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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05043129
Enrollment
200
Registered
2021-09-14
Start date
2021-09-04
Completion date
2022-09-04
Last updated
2021-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, HIV Infections

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.

Interventions

BIOLOGICALBiological/Vaccine: SARS-COV-2 VACCINE

The antibody titer and adverse reactions were observed.

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with adverse events after injection1 month after vaccinationThe vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.

Secondary

MeasureTime frameDescription
Titer and duration of COVID-19 antibody production after vaccination1 month after vaccinationThe titer and duration of COVID-19 antibody were produced at 1 month

Countries

China

Contacts

Primary ContactCHUAN DA CAI, PHD
597521685@qq.com18323409779
Backup ContactDAZHI ZHANG, PHD
dzhzhang@yahoo.com13452382818

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026