Created at Source Raw Value Validated value
June 25, 2024, noon usa

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. * within 14 days of known exposure to someone with confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection or coronavirus disease (covid-19). * acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. * participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that emergency use authorization (eua) vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to vaccination on protocol. participants will be allowed to enroll if they have already received booster doses of vaccine prior to enrolling on the protocol at least four weeks prior to vaccination on protocol. in this case, the protocol will administer a single booster dose of vaccination. documentation will be required. * known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. * chronic cardiovascular disease that is not controlled. * participants with a history of myocarditis (inflammation of the heart) or pericarditis (inflammation of the pericardium) * history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. * bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. * participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a participant on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. * prior/concomitant therapy * has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. * has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. * has received an inactivated vaccine within 14 days before the first dose of study treatment. * have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the participant must be sufficiently recovered and stable before treatment administration. --history of severe allergic reactions to any components of the study treatment. * has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (aes), or compromise the ability of the participant to give written informed consent. * active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). * history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * has involvement in the planning and/or conduct of the study. * female who is pregnant or breastfeeding * male or female participant of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. * within 14 days of known exposure to someone with confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection or coronavirus disease (covid-19). * acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. * participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that emergency use authorization (eua) vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to vaccination on protocol. participants will be allowed to enroll if they have already received booster doses of vaccine prior to enrolling on the protocol at least four weeks prior to vaccination on protocol. in this case, the protocol will administer a single booster dose of vaccination. documentation will be required. * known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. * chronic cardiovascular disease that is not controlled. * participants with a history of myocarditis (inflammation of the heart) or pericarditis (inflammation of the pericardium) * history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. * bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. * participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a participant on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. * prior/concomitant therapy * has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. * has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. * has received an inactivated vaccine within 14 days before the first dose of study treatment. * have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the participant must be sufficiently recovered and stable before treatment administration. --history of severe allergic reactions to any components of the study treatment. * has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (aes), or compromise the ability of the participant to give written informed consent. * active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). * history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * has involvement in the planning and/or conduct of the study. * female who is pregnant or breastfeeding * male or female participant of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

June 11, 2024, 4 p.m. usa

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. within 14 days of known exposure to someone with confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection or coronavirus disease (covid-19). acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that emergency use authorization (eua) vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to vaccination on protocol. participants will be allowed to enroll if they have already received booster doses of vaccine prior to enrolling on the protocol at least four weeks prior to vaccination on protocol. in this case, the protocol will administer a single booster dose of vaccination. documentation will be required. known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. chronic cardiovascular disease that is not controlled. participants with a history of myocarditis (inflammation of the heart) or pericarditis (inflammation of the pericardium) history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a participant on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. prior/concomitant therapy has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. has received an inactivated vaccine within 14 days before the first dose of study treatment. have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the participant must be sufficiently recovered and stable before treatment administration. --history of severe allergic reactions to any components of the study treatment. has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (aes), or compromise the ability of the participant to give written informed consent. active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. has involvement in the planning and/or conduct of the study. female who is pregnant or breastfeeding male or female participant of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. within 14 days of known exposure to someone with confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection or coronavirus disease (covid-19). acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that emergency use authorization (eua) vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to vaccination on protocol. participants will be allowed to enroll if they have already received booster doses of vaccine prior to enrolling on the protocol at least four weeks prior to vaccination on protocol. in this case, the protocol will administer a single booster dose of vaccination. documentation will be required. known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. chronic cardiovascular disease that is not controlled. participants with a history of myocarditis (inflammation of the heart) or pericarditis (inflammation of the pericardium) history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a participant on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. prior/concomitant therapy has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. has received an inactivated vaccine within 14 days before the first dose of study treatment. have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the participant must be sufficiently recovered and stable before treatment administration. --history of severe allergic reactions to any components of the study treatment. has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (aes), or compromise the ability of the participant to give written informed consent. active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. has involvement in the planning and/or conduct of the study. female who is pregnant or breastfeeding male or female participant of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

Nov. 3, 2022, 4 a.m. usa

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that eua vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to vaccination on protocol. participants will be allowed to enroll if they have already received booster doses of vaccine prior to enrolling on the protocol at least four weeks prior to vaccination on protocol. in this case, the protocol will administer a single booster dose of vaccination. documentation will be required. known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. chronic cardiovascular disease that is not controlled. participants with a history of myocarditis (inflammation of the heart) or pericarditis (inflammation of the pericardium) history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a participant on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. prior/concomitant therapy has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. has received an inactivated vaccine within 14 days before the first dose of study treatment. have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the participant must be sufficiently recovered and stable before treatment administration. --history of severe allergic reactions to any components of the study treatment. has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the participant to give written informed consent. active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. has involvement in the planning and/or conduct of the study. female who is pregnant or breastfeeding male or female participant of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that eua vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to vaccination on protocol. participants will be allowed to enroll if they have already received booster doses of vaccine prior to enrolling on the protocol at least four weeks prior to vaccination on protocol. in this case, the protocol will administer a single booster dose of vaccination. documentation will be required. known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. chronic cardiovascular disease that is not controlled. participants with a history of myocarditis (inflammation of the heart) or pericarditis (inflammation of the pericardium) history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a participant on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. prior/concomitant therapy has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. has received an inactivated vaccine within 14 days before the first dose of study treatment. have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the participant must be sufficiently recovered and stable before treatment administration. --history of severe allergic reactions to any components of the study treatment. has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the participant to give written informed consent. active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. has involvement in the planning and/or conduct of the study. female who is pregnant or breastfeeding male or female participant of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

June 10, 2022, 4:30 p.m. usa

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that eua vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to vaccination on protocol. patientparticipants will be allowed to enroll if they have already received a booster dose of vaccine prior to enrolling on the protocol at least four weeks prior to vaccination on protocol. in this case, the protocol will administer a single booster dose of vaccination. documentation will be required. known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. chronic cardiovascular disease that is not controlled. history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a participant on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. prior/concomitant therapy has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. has received an inactivated vaccine within 14 days before the first dose of study treatment. have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the participant must be sufficiently recovered and stable before treatment administration. history of severe allergic reactions to any components of the study treatment. active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: vitiligo or alopecia hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement any chronic skin condition such as eczema or celiac disease that does not require systemic therapy celiac disease controlled by diet alone. history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. solid tumor participants with a history of leptomeningeal carcinomatosis. has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the participant to give written informed consent. active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. has involvement in the planning and/or conduct of the study. female who is pregnant or breastfeeding male or female participant of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that eua vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to vaccination on protocol. patientparticipants will be allowed to enroll if they have already received a booster dose of vaccine prior to enrolling on the protocol at least four weeks prior to vaccination on protocol. in this case, the protocol will administer a single booster dose of vaccination. documentation will be required. known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. chronic cardiovascular disease that is not controlled. history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a participant on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. prior/concomitant therapy has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. has received an inactivated vaccine within 14 days before the first dose of study treatment. have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the participant must be sufficiently recovered and stable before treatment administration. history of severe allergic reactions to any components of the study treatment. active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: vitiligo or alopecia hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement any chronic skin condition such as eczema or celiac disease that does not require systemic therapy celiac disease controlled by diet alone. history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. solid tumor participants with a history of leptomeningeal carcinomatosis. has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the participant to give written informed consent. active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. has involvement in the planning and/or conduct of the study. female who is pregnant or breastfeeding male or female participant of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

June 9, 2022, 4 p.m. usa

None

None

Feb. 19, 2022, 5 p.m. usa

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that eua vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to vaccination on protocol. patientparticipants will be allowed to enroll if they have already received a booster dose of vaccine prior to enrolling on the protocol at least four weeks prior to vaccination on protocol. in this case, the protocol will administer a single booster dose of vaccination. documentation will be required. known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. chronic cardiovascular disease that is not controlled. history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a participant on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. prior/concomitant therapy has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. has received an inactivated vaccine within 14 days before the first dose of study treatment. have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the participant must be sufficiently recovered and stable before treatment administration. history of severe allergic reactions to any components of the study treatment. active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: vitiligo or alopecia hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement any chronic skin condition such as eczema or celiac disease that does not require systemic therapy celiac disease controlled by diet alone. history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. solid tumor participants with a history of leptomeningeal carcinomatosis. has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the participant to give written informed consent. active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. has involvement in the planning and/or conduct of the study. female who is pregnant or breastfeeding male or female participant of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that eua vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to vaccination on protocol. patientparticipants will be allowed to enroll if they have already received a booster dose of vaccine prior to enrolling on the protocol at least four weeks prior to vaccination on protocol. in this case, the protocol will administer a single booster dose of vaccination. documentation will be required. known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. chronic cardiovascular disease that is not controlled. history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a participant on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. prior/concomitant therapy has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. has received an inactivated vaccine within 14 days before the first dose of study treatment. have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the participant must be sufficiently recovered and stable before treatment administration. history of severe allergic reactions to any components of the study treatment. active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: vitiligo or alopecia hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement any chronic skin condition such as eczema or celiac disease that does not require systemic therapy celiac disease controlled by diet alone. history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. solid tumor participants with a history of leptomeningeal carcinomatosis. has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the participant to give written informed consent. active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. has involvement in the planning and/or conduct of the study. female who is pregnant or breastfeeding male or female participant of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

Nov. 17, 2021, 7 p.m. usa

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that eua vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to enrollment. documentation will be required. current treatment with investigational agents for prophylaxis against covid-19. known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. chronic cardiovascular disease that is not controlled. history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a patient on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. prior/concomitant therapy has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. has received an inactivated vaccine within 14 days before the first dose of study treatment. have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the patient must be sufficiently recovered and stable before treatment administration. history of severe allergic reactions to any components of the study treatment. active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: vitiligo or alopecia hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement any chronic skin condition such as eczema or celiac disease that does not require systemic therapy celiac disease controlled by diet alone. history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. solid tumor participants with a history of leptomeningeal carcinomatosis. has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the patient to give written informed consent. active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. has involvement in the planning and/or conduct of the study. female who is pregnant or breastfeeding male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. participants on the vaccine na(sqrroot) ve arms cannot have received any doses of the covid-19 vaccine. participants who have not completed a standard vaccination series due to initiation of vaccination in a foreign location (e.g., single dose of astra-zeneca vaccine or a similar situation) may be enrolled after discussion with the principal investigator. participants on the booster arms must have received all doses of their initial covid-19 vaccine (participants vaccinated with the janssen vaccine must have received the single dose of that eua vaccine for covid19, but all others must have received 2 doses) at least 4 weeks prior to enrollment. documentation will be required. current treatment with investigational agents for prophylaxis against covid-19. known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. chronic cardiovascular disease that is not controlled. history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a patient on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. prior/concomitant therapy has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. has received an inactivated vaccine within 14 days before the first dose of study treatment. have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the patient must be sufficiently recovered and stable before treatment administration. history of severe allergic reactions to any components of the study treatment. active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: vitiligo or alopecia hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement any chronic skin condition such as eczema or celiac disease that does not require systemic therapy celiac disease controlled by diet alone. history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. solid tumor participants with a history of leptomeningeal carcinomatosis. has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the patient to give written informed consent. active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. has involvement in the planning and/or conduct of the study. female who is pregnant or breastfeeding male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment.

June 11, 2021, 12:32 a.m. usa

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. - known history of sars-cov-2 infection or within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. - acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - prior administration of an investigational coronavirus (e.g., sars-cov-2, sars-cov, mers-cov) vaccine. - current treatment with investigational agents for prophylaxis against covid-19. - known history of hypotension or systolic blood pressure < 85 mm hg at the screening visit (day 0). - known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. - chronic cardiovascular disease that is not controlled. - history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. - bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. - participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a patient on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. - prior/concomitant therapy - has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. - has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. - has received an inactivated vaccine within 14 days before the first dose of study treatment. - have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the patient must be sufficiently recovered and stable before treatment administration. - history of severe allergic reactions to any components of the study treatment. - active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: - vitiligo or alopecia - hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement - any chronic skin condition such as eczema or celiac disease that does not require systemic therapy - celiac disease controlled by diet alone. - history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. - solid tumor participants with a history of leptomeningeal carcinomatosis. - has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the patient to give written informed consent. - active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). - history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - has involvement in the planning and/or conduct of the study. - female who is pregnant or breastfeeding - male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment. - post-allogeneic transplant participants who have not converted to donor chimerism.

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. - known history of sars-cov-2 infection or within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. - acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - prior administration of an investigational coronavirus (e.g., sars-cov-2, sars-cov, mers-cov) vaccine. - current treatment with investigational agents for prophylaxis against covid-19. - known history of hypotension or systolic blood pressure < 85 mm hg at the screening visit (day 0). - known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. - chronic cardiovascular disease that is not controlled. - history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. - bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. - participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a patient on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. - prior/concomitant therapy - has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. - has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. - has received an inactivated vaccine within 14 days before the first dose of study treatment. - have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the patient must be sufficiently recovered and stable before treatment administration. - history of severe allergic reactions to any components of the study treatment. - active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: - vitiligo or alopecia - hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement - any chronic skin condition such as eczema or celiac disease that does not require systemic therapy - celiac disease controlled by diet alone. - history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. - solid tumor participants with a history of leptomeningeal carcinomatosis. - has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the patient to give written informed consent. - active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). - history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - has involvement in the planning and/or conduct of the study. - female who is pregnant or breastfeeding - male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment. - post-allogeneic transplant participants who have not converted to donor chimerism.

April 29, 2021, 10:18 a.m. usa

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. - known history of sars-cov-2 infection or within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. - acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - prior administration of an investigational coronavirus (e.g., sars-cov-2, sars-cov, mers-cov) vaccine. - current treatment with investigational agents for prophylaxis against covid-19. - known history of hypotension or systolic blood pressure < 85 mm hg at the screening visit (day 0). - known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. - chronic cardiovascular disease that is not controlled. - history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. - bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. - participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a patient on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. - prior/concomitant therapy - has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. - has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. - has received an inactivated vaccine within 14 days before the first dose of study treatment. - have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the patient must be sufficiently recovered and stable before treatment administration. - diagnostic assessments - must not have experienced a > grade 3 immune related ae while receiving immunotherapy. note: participants with endocrine aes of any grade are permitted to enroll if they are stable while maintained on appropriate replacement therapy and are asymptomatic. - history of severe allergic reactions to any components of the study treatment. - active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: - vitiligo or alopecia - hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement - any chronic skin condition such as eczema or celiac disease that does not require systemic therapy - celiac disease controlled by diet alone. - history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. - solid tumor participants with a history of leptomeningeal carcinomatosis. - has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the patient to give written informed consent. - active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), - history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - has involvement in the planning and/or conduct of the study. - female who is pregnant or breastfeeding - male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment. - post-allogenic transplant participants who have not fully converted to donor chimerism, still on immunosuppressants such as cyclosporine, mycophenolate mofetil, tacrolimus (fk506), or participants with acute or chronic gvhd will be excluded.

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. - known history of sars-cov-2 infection or within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. - acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - prior administration of an investigational coronavirus (e.g., sars-cov-2, sars-cov, mers-cov) vaccine. - current treatment with investigational agents for prophylaxis against covid-19. - known history of hypotension or systolic blood pressure < 85 mm hg at the screening visit (day 0). - known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. - chronic cardiovascular disease that is not controlled. - history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. - bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. - participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a patient on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. - prior/concomitant therapy - has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. - has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. - has received an inactivated vaccine within 14 days before the first dose of study treatment. - have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the patient must be sufficiently recovered and stable before treatment administration. - diagnostic assessments - must not have experienced a > grade 3 immune related ae while receiving immunotherapy. note: participants with endocrine aes of any grade are permitted to enroll if they are stable while maintained on appropriate replacement therapy and are asymptomatic. - history of severe allergic reactions to any components of the study treatment. - active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: - vitiligo or alopecia - hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement - any chronic skin condition such as eczema or celiac disease that does not require systemic therapy - celiac disease controlled by diet alone. - history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. - solid tumor participants with a history of leptomeningeal carcinomatosis. - has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the patient to give written informed consent. - active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), - history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - has involvement in the planning and/or conduct of the study. - female who is pregnant or breastfeeding - male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment. - post-allogenic transplant participants who have not fully converted to donor chimerism, still on immunosuppressants such as cyclosporine, mycophenolate mofetil, tacrolimus (fk506), or participants with acute or chronic gvhd will be excluded.

April 23, 2021, 12:31 a.m. usa

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. - known history of sars-cov-2 infection or within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. - acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - prior administration of an investigational coronavirus (e.g., sars-cov-2, sars-cov, mers-cov) vaccine. - current treatment with investigational agents for prophylaxis against covid-19. - known history of hypotension or systolic blood pressure < 85 mm hg at the screening visit (day 0). - known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. - chronic cardiovascular disease that is not controlled. - history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. - bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. - participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a patient on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. - prior/concomitant therapy - has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. - has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. - have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the patient must be sufficiently recovered and stable before treatment administration. - diagnostic assessments - must not have experienced a > grade 3 immune related ae while receiving immunotherapy. note: participants with endocrine aes of any grade are permitted to enroll if they are stable while maintained on appropriate replacement therapy and are asymptomatic. - history of severe allergic reactions to any components of the study treatment. - active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: - vitiligo or alopecia - hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement - any chronic skin condition such as eczema or celiac disease that does not require systemic therapy - celiac disease controlled by diet alone. - history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. - solid tumor participants with a history of leptomeningeal carcinomatosis. - has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the patient to give written informed consent. - active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), - history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - has involvement in the planning and/or conduct of the study. - female who is pregnant or breastfeeding - male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment. - post-allogenic transplant participants who have not fully converted to donor chimerism, still on immunosuppressants such as cyclosporine, mycophenolate mofetil, tacrolimus (fk506), or participants with acute or chronic gvhd will be excluded.

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. - known history of sars-cov-2 infection or within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. - acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 degrees c/100.4 degrees f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - prior administration of an investigational coronavirus (e.g., sars-cov-2, sars-cov, mers-cov) vaccine. - current treatment with investigational agents for prophylaxis against covid-19. - known history of hypotension or systolic blood pressure < 85 mm hg at the screening visit (day 0). - known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. - chronic cardiovascular disease that is not controlled. - history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. - bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. - participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a patient on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. - prior/concomitant therapy - has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. - has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-guerin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. - have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the patient must be sufficiently recovered and stable before treatment administration. - diagnostic assessments - must not have experienced a > grade 3 immune related ae while receiving immunotherapy. note: participants with endocrine aes of any grade are permitted to enroll if they are stable while maintained on appropriate replacement therapy and are asymptomatic. - history of severe allergic reactions to any components of the study treatment. - active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: - vitiligo or alopecia - hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement - any chronic skin condition such as eczema or celiac disease that does not require systemic therapy - celiac disease controlled by diet alone. - history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. - solid tumor participants with a history of leptomeningeal carcinomatosis. - has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the patient to give written informed consent. - active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), - history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - has involvement in the planning and/or conduct of the study. - female who is pregnant or breastfeeding - male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment. - post-allogenic transplant participants who have not fully converted to donor chimerism, still on immunosuppressants such as cyclosporine, mycophenolate mofetil, tacrolimus (fk506), or participants with acute or chronic gvhd will be excluded.

April 22, 2021, 12:31 a.m. usa

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. - known history of sars-cov-2 infection or within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. - acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 (infinite)c/100.4 (infinite)f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - prior administration of an investigational coronavirus (e.g., sars-cov-2, sars-cov, mers-cov) vaccine. - current treatment with investigational agents for prophylaxis against covid-19. - known history of hypotension or systolic blood pressure < 85 mm hg at the screening visit (day 0). - known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. - chronic cardiovascular disease that is not controlled. - history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. - bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. - participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a patient on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. - prior/concomitant therapy - has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. - has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-gu(sqrroot)(copyright)rin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. - have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the patient must be sufficiently recovered and stable before treatment administration. - diagnostic assessments - must not have experienced a > grade 3 immune related ae while receiving immunotherapy. note: participants with endocrine aes of any grade are permitted to enroll if they are stable while maintained on appropriate replacement therapy and are asymptomatic. - history of severe allergic reactions to any components of the study treatment. - active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: - vitiligo or alopecia - hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement - any chronic skin condition such as eczema or celiac disease that does not require systemic therapy - celiac disease controlled by diet alone. - history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. - solid tumor participants with a history of leptomeningeal carcinomatosis. - has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the patient to give written informed consent. - active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), - history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - has involvement in the planning and/or conduct of the study. - female who is pregnant or breastfeeding - male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment. - post-allogenic transplant participants who have not fully converted to donor chimerism, still on immunosuppressants such as cyclosporine, mycophenolate mofetil, tacrolimus (fk506), or participants with acute or chronic gvhd will be excluded.

all participants meeting any of the exclusion criteria at baseline will be excluded from study participation. - known history of sars-cov-2 infection or within 14 days of known exposure to someone with confirmed sars cov2 infection or covid-19. - acutely ill or febrile 24 hours prior to or at the screening visit (day 0). fever is defined as a body temperature greater than or equal to 38.0 (infinite)c/100.4 (infinite)f. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. - prior administration of an investigational coronavirus (e.g., sars-cov-2, sars-cov, mers-cov) vaccine. - current treatment with investigational agents for prophylaxis against covid-19. - known history of hypotension or systolic blood pressure < 85 mm hg at the screening visit (day 0). - known diagnosis of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, asthma) that is not controlled. - chronic cardiovascular disease that is not controlled. - history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. - bleeding disorder considered a contraindication to intramuscular (im) injection or phlebotomy. - participated in an interventional clinical trial with an investigational agent within 28 days prior to the screening visit (day 0) or plans to do so while participating in this study. the site investigator may enroll a patient on the trial earlier than 28 days if enough time has passed to ensure that at least five half-lives have occurred. - prior/concomitant therapy - has received prior radiotherapy within 14 days before the first dose of study treatment. participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. a 7-day washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non-central nervous system (cns) disease. - has received a live vaccine within 30 days before the first dose of study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus calmette-gu(sqrroot)(copyright)rin (bcg), and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., flumist (registered trademark)) are live attenuated vaccines and are not allowed. - have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment. in all cases, the patient must be sufficiently recovered and stable before treatment administration. - diagnostic assessments - must not have experienced a > grade 3 immune related ae while receiving immunotherapy. note: participants with endocrine aes of any grade are permitted to enroll if they are stable while maintained on appropriate replacement therapy and are asymptomatic. - history of severe allergic reactions to any components of the study treatment. - active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or crohn s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome [granulomatosis with polyangiitis, graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). the following are exceptions to this criterion: - vitiligo or alopecia - hypothyroidism (e.g., following hashimoto syndrome) stable on hormone replacement - any chronic skin condition such as eczema or celiac disease that does not require systemic therapy - celiac disease controlled by diet alone. - history of primary immunodeficiency, allogenic solid organ transplantation, or tuberculosis. - solid tumor participants with a history of leptomeningeal carcinomatosis. - has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe or ongoing interstitial lung disease (ild), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring aes, or compromise the ability of the patient to give written informed consent. - active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), - history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - has involvement in the planning and/or conduct of the study. - female who is pregnant or breastfeeding - male or female patient of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study treatment. - post-allogenic transplant participants who have not fully converted to donor chimerism, still on immunosuppressants such as cyclosporine, mycophenolate mofetil, tacrolimus (fk506), or participants with acute or chronic gvhd will be excluded.