Clinical trial NCT05043129: Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Official title: Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Covid19
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected persons vaccinated with COVID-19 vaccine

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with adverse events after injection
timeFrame: 1 month after vaccination
measure: Number of participants with adverse events after injection
timeFrame: 3 months after vaccination
measure: Number of participants with adverse events after injection
timeFrame: 6 months after vaccination
Secondary outcomes:
measure: Titer and duration of COVID-19 antibody production after vaccination
timeFrame: 1 month after vaccination
measure: Titer and duration of COVID-19 antibody production after vaccination
timeFrame: 3 months after vaccination
measure: Titer and duration of COVID-19 antibody production after vaccination
timeFrame: 6 months after vaccination
Other outcomes:
Locations:
city: Chongqing
country: China
facility: China
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Hong Ren, PHD
role: PRINCIPAL_INVESTIGATOR
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