Created at Source Raw Value Validated value
April 8, 2022, 3:30 p.m. oms

To be eligible for the study, each HIV (+) participants must satisfy all of the following criteria: 1. Adolescent male or female aged = 12 to 17 years at screening and adult male or female aged = 18 to 64 years at screening (inclusive). 2. Written informed consent (and assent if adolescent), after review of the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee. For participants who cannot read or write, the consent must be witnessed by a literate third party not involved in study conduct. 3. Comply with study procedures, including potential home visits for COVID-19 follow-up. 4. Has completed a primary homologous vaccination series at least 3 months but no more than 6 months prior to enrollment. Vaccinations allowed include: a) mRNA (Moderna mRNA-1273 or Pfizer/BNT) – primary series is 2 doses b) Adenovector 26 (Janssen Ad26COVS1) – primary series is 1 dose, c) Inactivated whole virus (Sinopharm-BIBP) – primary series is 2 doses, 5. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level =40 mIU/mL]) must agree to consistently use an effective method of contraception from enrolment and agree to continue adequate contraception until 12 weeks after vaccination:a. Condoms (male or female) b. Diaphragm with spermicide c. Cervical cap with spermicide d. Intrauterine device e. Oral or patch contraceptives f. Hormonal Contraceptives implants or injection e.g., Norplant®, Depo-Provera®. g. Abstinence, as a form of contraception, is acceptable if in line with the participant’s lifestyle. NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Theseprocedures and laboratory test results must be confirmed by physical examination, by participant recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure.6. Medically stable at screening, as determined by the investigator (based on review of health status, vital signs, medical history, and targeted physical examination). Acceptable Vital signs as determined by the Principal Investigator or designee. 7. Receiving highly active antiretroviral therapy (HAART) and using the same regimen the past 8 weeks before screening. Changes in antiretroviral dosage within 8 weeks prior to entering the study are permitted. In addition, the exchange of pharmacological formulation (e.g., the conventional formulation for combination formulations) is allowed. If regimen has changed then the participant can be reconsidered for inclusion once the 8 weeks has passed. 8. An HIV-1 viral load < 1000 copies/mL and/or CD4 Count = 200 cells/mm3 within 3 months before randomization. May be taken during screening or utilize medical testing from clinic. 9. Documentation of HIV test result by HIV rapid test or assay as per the Ministry of Health guidelines in the respective countries irrespective of HIV status. Each HIV (-) participant must meet all the following criteria to be enrolled in this study: 1. Male or female aged = 18 to 64 years at screening, inclusive. 2. Willing and able to give informed consent prior to study enrolment and co

To be eligible for the study, each HIV (+) participants must satisfy all of the following criteria: 1. Adolescent male or female aged = 12 to 17 years at screening and adult male or female aged = 18 to 64 years at screening (inclusive). 2. Written informed consent (and assent if adolescent), after review of the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee. For participants who cannot read or write, the consent must be witnessed by a literate third party not involved in study conduct. 3. Comply with study procedures, including potential home visits for COVID-19 follow-up. 4. Has completed a primary homologous vaccination series at least 3 months but no more than 6 months prior to enrollment. Vaccinations allowed include: a) mRNA (Moderna mRNA-1273 or Pfizer/BNT) – primary series is 2 doses b) Adenovector 26 (Janssen Ad26COVS1) – primary series is 1 dose, c) Inactivated whole virus (Sinopharm-BIBP) – primary series is 2 doses, 5. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level =40 mIU/mL]) must agree to consistently use an effective method of contraception from enrolment and agree to continue adequate contraception until 12 weeks after vaccination:a. Condoms (male or female) b. Diaphragm with spermicide c. Cervical cap with spermicide d. Intrauterine device e. Oral or patch contraceptives f. Hormonal Contraceptives implants or injection e.g., Norplant®, Depo-Provera®. g. Abstinence, as a form of contraception, is acceptable if in line with the participant’s lifestyle. NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Theseprocedures and laboratory test results must be confirmed by physical examination, by participant recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure.6. Medically stable at screening, as determined by the investigator (based on review of health status, vital signs, medical history, and targeted physical examination). Acceptable Vital signs as determined by the Principal Investigator or designee. 7. Receiving highly active antiretroviral therapy (HAART) and using the same regimen the past 8 weeks before screening. Changes in antiretroviral dosage within 8 weeks prior to entering the study are permitted. In addition, the exchange of pharmacological formulation (e.g., the conventional formulation for combination formulations) is allowed. If regimen has changed then the participant can be reconsidered for inclusion once the 8 weeks has passed. 8. An HIV-1 viral load < 1000 copies/mL and/or CD4 Count = 200 cells/mm3 within 3 months before randomization. May be taken during screening or utilize medical testing from clinic. 9. Documentation of HIV test result by HIV rapid test or assay as per the Ministry of Health guidelines in the respective countries irrespective of HIV status. Each HIV (-) participant must meet all the following criteria to be enrolled in this study: 1. Male or female aged = 18 to 64 years at screening, inclusive. 2. Willing and able to give informed consent prior to study enrolment and co