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

inclusion criteria: 1. adults 18 to 65 years of age, inclusive, at screening. 2. willing and able to give informed consent prior to study enrollment and to comply with study procedures. 3. participants of childbearing potential (defined as any participant who has experienced menarche and who is not surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study or agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study. 1. condoms (male or female) with spermicide (if acceptable in-country) 2. diaphragm with spermicide 3. cervical cap with spermicide 4. intrauterine device 5. oral or patch contraceptives 6. norplant®, depo-provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy. 7. abstinence as a form of contraception is acceptable if in line with the participant's lifestyle. 4. vital signs must be within medically acceptable ranges prior to the first vaccination 5. agree to not participate in any other sars-cov-2 prevention or treatment trials for the duration of the study. for well-controlled plwh 6. plwh with a cluster of differentiation 4 (cd4) + t-cell count of ≥ 350 cells/μl at screening or viral load of ≤ 1,000 copies/ml. 7. plwh being managed on a stable/unchanged antiretroviral therapy (art) regimen for at least 2 months prior to enrollment. 8. no opportunistic infections in the past year. for less-well-controlled plwh 9. plwh with a cd4+ t-cell count of ≥ 200 and \< 350 cells/μl at screening or viral load of 1,000 to 10,000 copies/ml. 10. plwh being managed on a stable/unchanged (art) regimen for at least 1 month prior to enrollment.

inclusion criteria: 1. adults 18 to 65 years of age, inclusive, at screening. 2. willing and able to give informed consent prior to study enrollment and to comply with study procedures. 3. participants of childbearing potential (defined as any participant who has experienced menarche and who is not surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study or agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study. 1. condoms (male or female) with spermicide (if acceptable in-country) 2. diaphragm with spermicide 3. cervical cap with spermicide 4. intrauterine device 5. oral or patch contraceptives 6. norplant®, depo-provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy. 7. abstinence as a form of contraception is acceptable if in line with the participant's lifestyle. 4. vital signs must be within medically acceptable ranges prior to the first vaccination 5. agree to not participate in any other sars-cov-2 prevention or treatment trials for the duration of the study. for well-controlled plwh 6. plwh with a cluster of differentiation 4 (cd4) + t-cell count of ≥ 350 cells/μl at screening or viral load of ≤ 1,000 copies/ml. 7. plwh being managed on a stable/unchanged antiretroviral therapy (art) regimen for at least 2 months prior to enrollment. 8. no opportunistic infections in the past year. for less-well-controlled plwh 9. plwh with a cd4+ t-cell count of ≥ 200 and \< 350 cells/μl at screening or viral load of 1,000 to 10,000 copies/ml. 10. plwh being managed on a stable/unchanged (art) regimen for at least 1 month prior to enrollment.

Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: adults 18 to 65 years of age, inclusive, at screening. willing and able to give informed consent prior to study enrollment and to comply with study procedures. participants of childbearing potential (defined as any participant who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study or agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study. condoms (male or female) with spermicide (if acceptable in-country) diaphragm with spermicide cervical cap with spermicide intrauterine device oral or patch contraceptives norplant®, depo-provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy. abstinence as a form of contraception is acceptable if in line with the participant's lifestyle. vital signs must be within medically acceptable ranges prior to the first vaccination agree to not participate in any other sars-cov-2 prevention or treatment trials for the duration of the study. for well-controlled plwh plwh with a cluster of differentiation 4 (cd4) + t-cell count of ≥ 350 cells/μl at screening or viral load of ≤ 1,000 copies/ml. plwh being managed on a stable/unchanged antiretroviral therapy (art) regimen for at least 2 months prior to enrollment. no opportunistic infections in the past year. for less-well-controlled plwh plwh with a cd4+ t-cell count of ≥ 200 and < 350 cells/μl at screening or viral load of 1,000 to 10,000 copies/ml. plwh being managed on a stable/unchanged (art) regimen for at least 1 month prior to enrollment.

inclusion criteria: adults 18 to 65 years of age, inclusive, at screening. willing and able to give informed consent prior to study enrollment and to comply with study procedures. participants of childbearing potential (defined as any participant who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study or agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study. condoms (male or female) with spermicide (if acceptable in-country) diaphragm with spermicide cervical cap with spermicide intrauterine device oral or patch contraceptives norplant®, depo-provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy. abstinence as a form of contraception is acceptable if in line with the participant's lifestyle. vital signs must be within medically acceptable ranges prior to the first vaccination agree to not participate in any other sars-cov-2 prevention or treatment trials for the duration of the study. for well-controlled plwh plwh with a cluster of differentiation 4 (cd4) + t-cell count of ≥ 350 cells/μl at screening or viral load of ≤ 1,000 copies/ml. plwh being managed on a stable/unchanged antiretroviral therapy (art) regimen for at least 2 months prior to enrollment. no opportunistic infections in the past year. for less-well-controlled plwh plwh with a cd4+ t-cell count of ≥ 200 and < 350 cells/μl at screening or viral load of 1,000 to 10,000 copies/ml. plwh being managed on a stable/unchanged (art) regimen for at least 1 month prior to enrollment.

Nov. 11, 2021, 4:30 p.m. usa

inclusion criteria: 1. adults 18 to 65 years of age, inclusive, at screening. 2. willing and able to give informed consent prior to study enrollment and to comply with study procedures. 3. participants of childbearing potential (defined as any participant who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study or agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study. 1. condoms (male or female) with spermicide (if acceptable in-country) 2. diaphragm with spermicide 3. cervical cap with spermicide 4. intrauterine device 5. oral or patch contraceptives 6. norplant®, depo-provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy. 7. abstinence as a form of contraception is acceptable if in line with the participant's lifestyle. 4. vital signs must be within medically acceptable ranges prior to the first vaccination 5. agree to not participate in any other sars-cov-2 prevention or treatment trials for the duration of the study. for well-controlled plwh 6. plwh with a cluster of differentiation 4 (cd4) + t-cell count of ≥ 350 cells/μl at screening or viral load of ≤ 1,000 copies/ml. 7. plwh being managed on a stable/unchanged antiretroviral therapy (art) regimen for at least 2 months prior to enrollment. 8. no opportunistic infections in the past year. for less-well-controlled plwh 9. plwh with a cd4+ t-cell count of ≥ 200 and < 350 cells/μl at screening or viral load of 1,000 to 10,000 copies/ml. 10. plwh being managed on a stable/unchanged (art) regimen for at least 1 month prior to enrollment.

inclusion criteria: 1. adults 18 to 65 years of age, inclusive, at screening. 2. willing and able to give informed consent prior to study enrollment and to comply with study procedures. 3. participants of childbearing potential (defined as any participant who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study or agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study. 1. condoms (male or female) with spermicide (if acceptable in-country) 2. diaphragm with spermicide 3. cervical cap with spermicide 4. intrauterine device 5. oral or patch contraceptives 6. norplant®, depo-provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy. 7. abstinence as a form of contraception is acceptable if in line with the participant's lifestyle. 4. vital signs must be within medically acceptable ranges prior to the first vaccination 5. agree to not participate in any other sars-cov-2 prevention or treatment trials for the duration of the study. for well-controlled plwh 6. plwh with a cluster of differentiation 4 (cd4) + t-cell count of ≥ 350 cells/μl at screening or viral load of ≤ 1,000 copies/ml. 7. plwh being managed on a stable/unchanged antiretroviral therapy (art) regimen for at least 2 months prior to enrollment. 8. no opportunistic infections in the past year. for less-well-controlled plwh 9. plwh with a cd4+ t-cell count of ≥ 200 and < 350 cells/μl at screening or viral load of 1,000 to 10,000 copies/ml. 10. plwh being managed on a stable/unchanged (art) regimen for at least 1 month prior to enrollment.