HIV/AIDS,COVID-19
Conditions
Interventions
HIV-infected individuals with good immune reconstitution (COVID-19 inactivated vaccine booster dose cohort):None
HIV-infected individuals with poor immune reconstitution (COVID-19 inactivated vaccine booster dose cohort):None
Healthy controls (COVID-19 inactivated vaccine booster dose cohort):None
HIV-infected individuals (SARS-CoV-2 breakthrough infection cohort):None
Healthy controls (SARS-CoV-2 breakthrough infection cohort):None
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. COVID-19 Inactivated Vaccine Booster Vaccination Cohort (1) Inclusion criteria for HIV-infected participants: 1) Aged 18–60 years, either gender; 2) HIV-1 antibody positive by ELISA and confirmed by Western Blot; 3) Have completed two doses of COVID-19 inactivated vaccine (developed by Sinovac Life Sciences Co., Ltd. or Beijing Institute of Biological Products Co., Ltd., China National Biotec Group) at least 6 months prior; 4) No history of COVID-19 infection or exposure; 5) On ART for >2 years and with sustained virological suppression (2 years and with sustained virological suppression (<50 copies/mL); 7) Willing to sign the informed consent form. (2) Inclusion criteria for healthy controls: 1) Age and sex matched to HIV-infected participants; 2) Have completed three doses of COVID-19 inactivated vaccine (developed by Sinovac Life Sciences Co., Ltd. or Beijing Institute of Biological Products Co., Ltd., China National Biotec Group); 3) Confirmed SARS-CoV-2 infection by nucleic acid testing or antigen self-testing during December 10, 2022 to December 14, 2022; 4) No prior history of COVID-19 infection or exposure; 5) Willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. COVID-19 Inactivated Vaccine Booster Vaccination Cohort (1) Exclusion criteria for HIV-infected participants: 1) Presence of active opportunistic infections or AIDS-related malignancies at the time of blood sampling; or occurrence of opportunistic infections within 3 months prior to sampling with unstable condition within 2 weeks before sampling; 2) Severe hepatic or renal insufficiency at the time of blood sampling; 3) History of allergy to previous vaccinations; 4) Receipt of other vaccines within the past 1 month; 5) Pregnant or breastfeeding women. (2) Exclusion criteria for healthy controls: 1) Severe hepatic or renal insufficiency at the time of blood sampling; 2) History of allergy to previous vaccinations; 3) Receipt of other vaccines within the past 1 month; 4) Pregnant or breastfeeding women. 2. COVID-19 Breakthrough Infection Cohort (1) Exclusion criteria for HIV-infected participants: 1) Presence of active opportunistic infections or AIDS-related malignancies at the time of blood sampling; or occurrence of opportunistic infections within 3 months prior to sampling with unstable condition within 2 weeks before sampling; 2) Severe hepatic or renal insufficiency at the time of blood sampling; 3) Pregnant or breastfeeding women. (2) Exclusion criteria for healthy controls: 1) Severe hepatic or renal insufficiency at the time of blood sampling; 2) Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-S-RBD IgG;Neutralizing antibody;ADCC effector;CD4 cell count;HIV viral load; | — |
Countries
China
Contacts
Public ContactZhao Hongxin
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed