The Efficacy of COVID-19 Vaccine in Patients With HIV Infection，a Prospective and Multicenter Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- People Living With HIV
- Sponsor
- Beijing 302 Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection
- Last Updated
- 4 years ago
Overview
Brief Summary
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with HIV may be at higher risk than those without HIV for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of coronavirus vaccine for patients with HIV.
Detailed Description
This study is a prospective, single-arm, open-label clinical trial. A total of 200 patients with HIV infection were included in this vaccination study. All of the patients will further accept 12 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age above 18 years and less than 60 years
- •Patients diagnosed as HIV infection with viral inhibition or preparing to start antivirus therapy were included .
- •The functions of multi-organs were normal or basically normal, and there are no contraindications for vaccination.
Exclusion Criteria
- •Patients with acute attack of chronic diseases.
- •Patients have history of convulsion, epilepsy, encephalopathy and psychosis.
- •Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
- •Pregnant or lactating women.
- •Suffering serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
- •Patients have severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / uroedema.
- •Patients who are receiving immunosuppressants such as glucocorticoid.
Outcomes
Primary Outcomes
The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection
Time Frame: Within 2 months after the first dose of COVID-19 vaccination
We design a questionnaire for collecting the side effect, answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire. The questionnaire will be collected on each visit, and blood is drawn for laboratory test.
The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection
Time Frame: Within 2 months after the first dose of COVID-19 vaccination
The titers of anti-SARS-CoV-2 antibodies will be detected on each follow-up time for evaluating the efficacy and persistence of COVID-19 vaccine in patients with HIV infection.
Secondary Outcomes
- The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection(Within 13 months after the first dose of COVID-19 vaccination)
- The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection(Within 13 months after the first dose of COVID-19 vaccination)