Immunogenicity and Safety of COVID-19 Vaccine in People Living With HIV

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of COVID-19 Vaccine in Patients With HIV Infection，a Prospective and Multicenter Clinical Trial

Conditions
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People Living With HIV, COVID-19, Vaccine

Intervention / Treatment
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* Biological: Coronavirus vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coronavirus vaccination<br>Patients in the experimental need to accept the coronavirus vaccination | Biological: Coronavirus vaccine<br>* Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection | 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. | Within 2 months after the first dose of COVID-19 vaccination | 
| The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection | 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. | Within 2 months after the first dose of COVID-19 vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection | 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. | Within 13 months after the first dose of COVID-19 vaccination | 
| The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection | 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. | Within 13 months after the first dose of COVID-19 vaccination |