A Partially-Blinded, Randomized, Phase 3 Study to Evaluate the Immunogenicity and Safety of CpG/Alum-adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) in Healthy Adults and Individuals with HIV Infection

INTERVENTION: CpG 1018 alumadjuvanted SCB2019 vaccine placebo CONDITION: ; severe acute respiratory syndrome coronavirus 2 SARS CoV 2 severe acute respiratory syndrome coronavirus 2 SARS CoV 2 PRIMARY OUTCOME: To describe immunogenicity of the SCB‐2019 vaccine in both participants with HIV infection and healthy participants, who received 2‐dose vaccination series 3 or 6 weeks apart, in terms of SARS‐CoV‐2 neutralizing titers, 21 days after second vaccination with SCB‐2019. SECONDARY OUTCOME: ; ‐To describe immunogenicity of the SCB‐2019 vaccine in both participants with HIV infection and healthy participants, who received 2‐dose vaccination series 3 or 6 weeks apart, in terms of SARS‐CoV‐2 neutralizing titers and antibodies specific to SCB‐2019 antigen ; ‐To describe immunogenicity of the SCB‐2019 vaccine in participants with HIV infection, who received 2‐dose vaccination series 3 or 6 weeks apart, by baseline CD4+ T‐cell count and RNA viral load ; ‐To describe changes in CD4+ T‐cell count and HIV RNA viral load compared to baseline ; INCLUSION CRITERIA: 1. Male or female =18 years of age. 2. Individuals or their witnesses in case of illiteracy are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures. 3. Individuals are willing and able to give an informed consent, prior to screening. 4. Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception using a highly effective licensed method of birth control for 30 days prior to the first vaccination and has a negative pregnancy test on the day of vaccination and must agree to continue such precautions during until 90 days after the last vaccination. 5. Male participants must agree to employ acceptable contraception from the day of first dose of the study vaccine/comparator until 6 months after the first dose of the study vaccine/comparator and refrain from donating sperm during this period.