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

NCT ID: NCT05043129

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-04
• Study Completion Date: 2022-09-04

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.

Conditions

HIV Infections; Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV infenction/AIDS

experimental group

Biological/Vaccine: SARS-COV-2 VACCINE

Intervention Type: BIOLOGICAL

The antibody titer and adverse reactions were observed.

Healthy population

Control group

Biological/Vaccine: SARS-COV-2 VACCINE

Intervention Type: BIOLOGICAL

The antibody titer and adverse reactions were observed.

Interventions

Biological/Vaccine: SARS-COV-2 VACCINE

The antibody titer and adverse reactions were observed.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hong Ren

Dr/ Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Ren, PHD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Chongqing Medical University

Locations

China

Chongqing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

CHUAN DA CAI, PHD

Role: CONTACT

597521685@qq.com

18323409779

DAZHI ZHANG, PHD

Role: CONTACT

dzhzhang@yahoo.com

13452382818

Facility Contacts

DACHUAN CAI, PHD

Role: primary

597521685@qq.com

18323409779

DAZHI ZHANG, PHD

Role: backup

dzhzhang@yahoo.com

13452382818

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 34446016 (View on PubMed)

Ao L, Lu T, Cao Y, Chen Z, Wang Y, Li Z, Ren X, Xu P, Peng M, Chen M, Zhang G, Xiang D, Cai D, Hu P, Shi X, Zhang D, Ren H. Safety and immunogenicity of inactivated SARS-CoV-2 vaccines in people living with HIV. Emerg Microbes Infect. 2022 Dec;11(1):1126-1134. doi: 10.1080/22221751.2022.2059401.

Reference Type: DERIVED

PMID: 35369854 (View on PubMed)

Other Identifiers

2021-43

Identifier Type: -

Identifier Source: org_study_id