Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
HIV-infected people vaccinated with COVID-19 vaccine:None
Non-HIV infected people vaccinated with COVID-19 vaccine:None
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Exposure group: (1) Aged between 18 and 65 years (provide legal identification); (2) Able to understand and voluntarily sign written informed consent; (3) Willing to complete the experiment according to the study plan; (4) Two doses of Sinovac novel coronavirus vaccine have been completed, and the current dose is 5-9 months after the second dose; (5) Subjects were scheduled to receive Sinovac booster vaccine within the last month; (6) HIV antibody positive after rapid HIV test. 2. Control group: (1) Aged between 18 and 65 years (provide legal identification); (2) Able to understand and voluntarily sign written informed consent; (3) Willing to complete the experiment according to the study plan; (4) Two doses of Sinovac novel coronavirus vaccine have been completed, and the current dose is 5-9 months after the second dose; (5) Subjects were scheduled to receive Sinovac booster vaccine within the last month; (6) HIV antibody negative after rapid HIV test and no record of previous HIV diagnosis; (7) The age (up and down 3 years), gender and related underlying diseases of the HIV infected subjects were balanced and comparable with those of the exposed group.
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical trials before enrollment and during the follow-up period, or planned to participate in other clinical trials during the clinical trials; 2. History of novel coronavirus infection (laboratory confirmed); 3. Have received three or more doses of COVID-19 vaccine; 4. Experience of mixed vaccination of COVID-19 vaccine; 5. Severe adverse reactions, such as urticaria, dyspnea and angioneurotic edema, occurred during the basic immunization phase of COVID-19 vaccine; 6. Have an autoimmune disease (e.g., systemic lupus erythematosus) or an immune deficiency/immunosuppression not associated with HIV infection (e.g., after organ transplantation); 7. Subjects with serious chronic diseases, such as severe cardiovascular diseases, hypertension that cannot be controlled by drugs, diabetes, liver and kidney diseases, malignant tumors, etc.; 8. Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; 9. Abnormal coagulation function (such as lack of coagulation factor, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder diagnosed by a doctor; 10. Have received immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, superficial corticosteroid therapy for acute non-concurrent dermatitis) in the past 6 months or plans to receive them during the study period; 11. A long history of alcohol or drug abuse; 12. Received blood products in the 3 months prior to participating in the study, or planned to receive treatment for the above-mentioned diseases during the study period; 13. Subjects have any other factors that, in the investigator's judgment, make them unfit to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of adverse effect;Total antibody;S-IgG;S-IgM;N-IgG;Neutralizing antibody; | — |
Secondary
| Measure | Time frame |
|---|---|
| T cell immunity; | — |
Countries
China
Contacts
Public ContactXu Junjie
Peking University Shenzhen Hospital
Outcome results
None listed