Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection

Study Overview
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Brief Summary
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On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). People infected with human immunodeficiency virus (HIV) are affected by their underlying diseases and are listed by the World Health Organization (WHO) as a high-risk population of SARS-CoV-2 infection.To evaluate the safety and effectiveness of COVID-19 vaccine in those patients with human immunodeficiency virus infection , and to guide the COVID-19 vaccination more scientifically, reasonably and effectively, this study was carried out.

Detailed Description
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People infected with human immunodeficiency virus (HIV), affected by their underlying diseases, are listed by the World Health Organization (WHO) as a high-risk population for SARS-CoV-2 infection.. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. The safety and effectiveness of COVID-19 vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively. The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University. Patients with contraindications for vaccination will be excluded. The detected indexes included blood routine test, CD4, HIV virus load, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and HIV infenction people after vaccination ( 1, 3, 6 months after vaccination). The adverse reactions related to the vaccine were recorded.

Official Title
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Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection

Conditions
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HIV Infections, Covid19

Intervention / Treatment
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* Biological: Biological/Vaccine: SARS-COV-2 VACCINE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infection group: a. The HIV positive diagnosis is clear; b. 18-80 years old; c. Has been vaccinated against the COVID-19 ; d. Volunteer to participate in the project; Healthy control group: a. HIV negative; b. Age 18-80 years old; c. The COVID-19 vaccination has been completed; d. Volunteer to participate in the project Exclusion Criteria: Previous confirmed case of COVID-19 confirmed contact history of COVID-19 vaccination contraindications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV infenction/AIDS<br>experimental group | Biological: Biological/Vaccine: SARS-COV-2 VACCINE<br>* The antibody titer and adverse reactions were observed.<br>|
| Healthy population<br>Control group | Biological: Biological/Vaccine: SARS-COV-2 VACCINE<br>* The antibody titer and adverse reactions were observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events after injection | The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated. | 1 month after vaccination | 
| Number of participants with adverse events after injection | The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated. | 3 months after vaccination | 
| Number of participants with adverse events after injection | The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated. | 6 months after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 1 month | 1 month after vaccination | 
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 3 months | 3 months after vaccination | 
| Titer and duration of COVID-19 antibody production after vaccination | The titer and duration of COVID-19 antibody were produced at 6 months | 6 months after vaccination |