Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

Phase 1 <br/ >1. Ability to provide written informed consent (Audio video consent for vulnerable <br/ >subjects). <br/ >2. Participants of either gender of age between �18 to �55 years. <br/ >3. Good general health as determined by the discretion of investigator (vital signs (heart rate �60 to�100 bpm, blood pressure systolic �90 mm Hg and <140 mm <br/ >Hg, diastolic � 60 mm Hg and <90 mm Hg, oral temperature <100.4ºF), medical <br/ >history, and physical examination). <br/ >4. Expressed interest and availability to fulfill the study requirements. <br/ >5. For a female participant of child-bearing potential, planning to avoid becoming <br/ >pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination <br/ >6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ >7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ >8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination <br/ >9. Agrees not to participate in another clinical trial at any time during the study period. <br/ >10. Agrees to remain in the study area for the entire duration of the study. <br/ >11. Willing to allow storage and future use of biological samples for future research. <br/ > <br/ >Phase 2: <br/ >1. Ability to provide written informed consent (Audio video consent for vulnerable subjects). <br/ >2. Participants of either gender of age between �12 to � 65 years. <br/ >3. Good general health as determined by the discretion of investigator (vital signs (heart rate �60 to�100 bpm, blood pressure systolic �90 mm Hg and <140 mm <br/ >Hg, diastolic � 60 mm Hg and <90 mm Hg, oral temperature <100.4ºF), medical history, and physical examination). <br/ >4. Expressed interest and availability to fulfill the study requirements. <br/ >5. For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study <br/ >enrolment until at least four weeks after the last vaccination and agrees not to participate in another clinical trial at any time during the study period. <br/ >6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ >7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ >8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination. <br/ >9. Agrees to remain in the study area for the entire duration of the study. <br/ >10. Willing to allow storage and future use of biological samples for future research. <br/ >

Phase 1 <br/ >1. Ability to provide written informed consent (Audio video consent for vulnerable <br/ >subjects). <br/ >2. Participants of either gender of age between �18 to �55 years. <br/ >3. Good general health as determined by the discretion of investigator (vital signs (heart rate �60 to�100 bpm, blood pressure systolic �90 mm Hg and <140 mm <br/ >Hg, diastolic � 60 mm Hg and <90 mm Hg, oral temperature <100.4ºF), medical <br/ >history, and physical examination). <br/ >4. Expressed interest and availability to fulfill the study requirements. <br/ >5. For a female participant of child-bearing potential, planning to avoid becoming <br/ >pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination <br/ >6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ >7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ >8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination <br/ >9. Agrees not to participate in another clinical trial at any time during the study period. <br/ >10. Agrees to remain in the study area for the entire duration of the study. <br/ >11. Willing to allow storage and future use of biological samples for future research. <br/ > <br/ >Phase 2: <br/ >1. Ability to provide written informed consent (Audio video consent for vulnerable subjects). <br/ >2. Participants of either gender of age between �12 to � 65 years. <br/ >3. Good general health as determined by the discretion of investigator (vital signs (heart rate �60 to�100 bpm, blood pressure systolic �90 mm Hg and <140 mm <br/ >Hg, diastolic � 60 mm Hg and <90 mm Hg, oral temperature <100.4ºF), medical history, and physical examination). <br/ >4. Expressed interest and availability to fulfill the study requirements. <br/ >5. For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study <br/ >enrolment until at least four weeks after the last vaccination and agrees not to participate in another clinical trial at any time during the study period. <br/ >6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ >7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ >8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination. <br/ >9. Agrees to remain in the study area for the entire duration of the study. <br/ >10. Willing to allow storage and future use of biological samples for future research. <br/ >

Nov. 13, 2021, 5:33 p.m. oms

July 30, 2021, 1:30 p.m. oms

Phase 1 <br/ >1. Ability to provide written informed consent (Audio video consent for vulnerable <br/ >subjects). <br/ >2. Participants of either gender of age between �18 to �55 years. <br/ >3. Good general health as determined by the discretion of investigator (vital signs (heart rate �60 to�100 bpm, blood pressure systolic �90 mm Hg and <140 mm <br/ >Hg, diastolic � 60 mm Hg and <90 mm Hg, oral temperature <100.4ºF), medical <br/ >history, and physical examination). <br/ >4. Expressed interest and availability to fulfill the study requirements. <br/ >5. For a female participant of child-bearing potential, planning to avoid becoming <br/ >pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination <br/ >6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ >7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ >8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination <br/ >9. Agrees not to participate in another clinical trial at any time during the study period. <br/ >10. Agrees to remain in the study area for the entire duration of the study. <br/ >11. Willing to allow storage and future use of biological samples for future research. <br/ > <br/ >Phase 2: <br/ >1. Ability to provide written informed consent (Audio video consent for vulnerable subjects). <br/ >2. Participants of either gender of age between �12 to � 65 years. <br/ >3. Good general health as determined by the discretion of investigator (vital signs (heart rate �60 to�100 bpm, blood pressure systolic �90 mm Hg and <140 mm <br/ >Hg, diastolic � 60 mm Hg and <90 mm Hg, oral temperature <100.4ºF), medical history, and physical examination). <br/ >4. Expressed interest and availability to fulfill the study requirements. <br/ >5. For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study <br/ >enrolment until at least four weeks after the last vaccination and agrees not to participate in another clinical trial at any time during the study period. <br/ >6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ >7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ >8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination. <br/ >9. Agrees to remain in the study area for the entire duration of the study. <br/ >10. Willing to allow storage and future use of biological samples for future research. <br/ >

Phase 1 <br/ >1. Ability to provide written informed consent (Audio video consent for vulnerable <br/ >subjects). <br/ >2. Participants of either gender of age between �18 to �55 years. <br/ >3. Good general health as determined by the discretion of investigator (vital signs (heart rate �60 to�100 bpm, blood pressure systolic �90 mm Hg and <140 mm <br/ >Hg, diastolic � 60 mm Hg and <90 mm Hg, oral temperature <100.4ºF), medical <br/ >history, and physical examination). <br/ >4. Expressed interest and availability to fulfill the study requirements. <br/ >5. For a female participant of child-bearing potential, planning to avoid becoming <br/ >pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination <br/ >6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ >7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ >8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination <br/ >9. Agrees not to participate in another clinical trial at any time during the study period. <br/ >10. Agrees to remain in the study area for the entire duration of the study. <br/ >11. Willing to allow storage and future use of biological samples for future research. <br/ > <br/ >Phase 2: <br/ >1. Ability to provide written informed consent (Audio video consent for vulnerable subjects). <br/ >2. Participants of either gender of age between �12 to � 65 years. <br/ >3. Good general health as determined by the discretion of investigator (vital signs (heart rate �60 to�100 bpm, blood pressure systolic �90 mm Hg and <140 mm <br/ >Hg, diastolic � 60 mm Hg and <90 mm Hg, oral temperature <100.4ºF), medical history, and physical examination). <br/ >4. Expressed interest and availability to fulfill the study requirements. <br/ >5. For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study <br/ >enrolment until at least four weeks after the last vaccination and agrees not to participate in another clinical trial at any time during the study period. <br/ >6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ >7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ >8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination. <br/ >9. Agrees to remain in the study area for the entire duration of the study. <br/ >10. Willing to allow storage and future use of biological samples for future research. <br/ >