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

• Conditions: HIV Infections; Covid19

• Registration Number: NCT05043129
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-04
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-13
• Study First Posted: 2021-09-14
• Last Update Posted: 2021-09-17
• Primary Completion: 2022-03-01
• Study Completion: 2022-09-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. 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;
2. 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

1. Previous confirmed case of COVID-19
2. confirmed contact history of COVID-19
3. vaccination contraindications.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events after injection	6 months after vaccination	The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.

Secondary Outcome Measures

Name	Time	Method
Titer and duration of COVID-19 antibody production after vaccination	6 months after vaccination	The titer and duration of COVID-19 antibody were produced at 6 months

Trial Locations

Locations (1)

China; 🇨🇳 Chongqing, China