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

inclusion criteria: 1. men and women between the ages of 18 and 60 years (at the time of consent). 2. all study subjects have received three doses of registered mrna vaccine/s, the last dose given ≥ 3 months before inclusion in this study. 3. healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments. 4. no clinically significant laboratory abnormalities as determined by the investigator at screening. note: one retest of lab tests is allowed within the screening window. 5. negative hiv 1/2 antibody/antigen test, hepatitis b surface antigen (hbsag), and hepatitis c virus (hcv) antibody at screening. 6. participant with a body mass index (bmi) 20-30.0 kg/m2. 7. provide written informed consent before initiation of any study procedures. 8. a female participant is eligible for this study if she is one of the following: * of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year) * of childbearing potential but agrees to practice highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 3 months after vaccination. highly effective methods of contraception include one or more of the following: 1. male partner who is sterile (vasectomised) prior to the female study subject's entry into the study and is the sole sexual partner for the female subject; 2. hormonal (oral, intravaginal, transdermal, implantable or injectable) 3. an intrauterine hormone-releasing system (ius) 4. an intrauterine device (iud) with a documented failure rate of \< 1%. 9. a female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 3 months after vaccination. 10. a male participant who is sexually active is eligible if he is willing to use a condom from the screening visit up to 3 months after vaccination except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal, is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective method of contraception. 11. able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.

inclusion criteria: 1. men and women between the ages of 18 and 60 years (at the time of consent). 2. all study subjects have received three doses of registered mrna vaccine/s, the last dose given ≥ 3 months before inclusion in this study. 3. healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments. 4. no clinically significant laboratory abnormalities as determined by the investigator at screening. note: one retest of lab tests is allowed within the screening window. 5. negative hiv 1/2 antibody/antigen test, hepatitis b surface antigen (hbsag), and hepatitis c virus (hcv) antibody at screening. 6. participant with a body mass index (bmi) 20-30.0 kg/m2. 7. provide written informed consent before initiation of any study procedures. 8. a female participant is eligible for this study if she is one of the following: * of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year) * of childbearing potential but agrees to practice highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 3 months after vaccination. highly effective methods of contraception include one or more of the following: 1. male partner who is sterile (vasectomised) prior to the female study subject's entry into the study and is the sole sexual partner for the female subject; 2. hormonal (oral, intravaginal, transdermal, implantable or injectable) 3. an intrauterine hormone-releasing system (ius) 4. an intrauterine device (iud) with a documented failure rate of \< 1%. 9. a female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 3 months after vaccination. 10. a male participant who is sexually active is eligible if he is willing to use a condom from the screening visit up to 3 months after vaccination except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal, is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective method of contraception. 11. able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.

Jan. 19, 2023, 4 a.m. usa

inclusion criteria: men and women between the ages of 18 and 60 years (at the time of consent). all study subjects have received three doses of registered mrna vaccine/s, the last dose given ≥ 3 months before inclusion in this study. healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments. no clinically significant laboratory abnormalities as determined by the investigator at screening. note: one retest of lab tests is allowed within the screening window. negative hiv 1/2 antibody/antigen test, hepatitis b surface antigen (hbsag), and hepatitis c virus (hcv) antibody at screening. participant with a body mass index (bmi) 20-30.0 kg/m2. provide written informed consent before initiation of any study procedures. a female participant is eligible for this study if she is one of the following: of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year) of childbearing potential but agrees to practice highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 3 months after vaccination. highly effective methods of contraception include one or more of the following: male partner who is sterile (vasectomised) prior to the female study subject's entry into the study and is the sole sexual partner for the female subject; hormonal (oral, intravaginal, transdermal, implantable or injectable) an intrauterine hormone-releasing system (ius) an intrauterine device (iud) with a documented failure rate of < 1%. a female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 3 months after vaccination. a male participant who is sexually active is eligible if he is willing to use a condom from the screening visit up to 3 months after vaccination except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal, is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective method of contraception. able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.

inclusion criteria: men and women between the ages of 18 and 60 years (at the time of consent). all study subjects have received three doses of registered mrna vaccine/s, the last dose given ≥ 3 months before inclusion in this study. healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments. no clinically significant laboratory abnormalities as determined by the investigator at screening. note: one retest of lab tests is allowed within the screening window. negative hiv 1/2 antibody/antigen test, hepatitis b surface antigen (hbsag), and hepatitis c virus (hcv) antibody at screening. participant with a body mass index (bmi) 20-30.0 kg/m2. provide written informed consent before initiation of any study procedures. a female participant is eligible for this study if she is one of the following: of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year) of childbearing potential but agrees to practice highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 3 months after vaccination. highly effective methods of contraception include one or more of the following: male partner who is sterile (vasectomised) prior to the female study subject's entry into the study and is the sole sexual partner for the female subject; hormonal (oral, intravaginal, transdermal, implantable or injectable) an intrauterine hormone-releasing system (ius) an intrauterine device (iud) with a documented failure rate of < 1%. a female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 3 months after vaccination. a male participant who is sexually active is eligible if he is willing to use a condom from the screening visit up to 3 months after vaccination except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal, is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective method of contraception. able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.