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A prospective cohort study on side effects, production of protective antibodies and effects of antiretroviral therapy in HIV infected patients after vaccination with SARS-CoV-2 vaccines

A prospective cohort study on side effects, production of protective antibodies and effects of antiretroviral therapy in HIV infected patients after vaccination with SARS-CoV-2 vaccines

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043183
Enrollment
Unknown
Registered
2021-02-08
Start date
2021-02-05
Completion date
Unknown
Last updated
2021-05-24

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

Conditions

AIDS/COVID-19

Interventions

non-exposed group 1: non-HIV patients vaccinated with SARS-CoV-2 vaccines:Nil
non-exposed group 2: HIV-patients without SARS-CoV-2 vaccines:Nil
exposure group: HIV-patients vaccinated with SARS-CoV-2 vaccines:Nil

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Exposure group (HIV infected persons vaccinated with new crown vaccine): (1) Those who were HIV positive by Western blotting and had a confirmed HIV report. (2) Subjects aged 18-65 years old. (3) The subjects who were recently vaccinated with new crown vaccine. (4) The subjects who signed the written informed consent for the investigation contents and laboratory testing items of the project. (5) Subjects willing to participate in the 9-month follow-up survey. 2. Non exposure group 1 (non HIV infected subjects vaccinated with the new crown vaccine) 1. Subjects with negative HIV antibody by rapid blood test. 2. Articles 2-5 are the same as those in the exposure group. 3. Subjects matched with the characteristics of HIV infected people who enrolled in the project. 3. Non exposure group 2 (HIV infected subjects who were not vaccinated with the new crown vaccine) (1) Western blot was used to detect HIV antibody positive subjects with confirmed HIV diagnosis report. (2) Subjects aged 18-65 years old. (3) Subjects who were not vaccinated with neocrown vaccine. (4) The subjects who signed the written informed consent for the investigation contents and laboratory testing items of the project. (5) Subjects willing to participate in the 9-month follow-up survey.

Exclusion criteria

Exclusion criteria: 1. Exposure group (HIV infected persons vaccinated with new crown vaccine): (1) Patients with severe mental and neurological disorders. (2) Patients with mental retardation or inability to communicate effectively with researchers. 2. Non exposure group 1 (non HIV infected subjects vaccinated with the new crown vaccine) (1) The above two exclusion criteria are the same as those for HIV infected people. (2) HIV fast test positive subjects. 3. Non exposure group 2 (HIV infected subjects who were not vaccinated with the new crown vaccine) (1) Patients with severe mental and neurological disorders. (2) Subjects with mental retardation or inability to communicate effectively with researchers.

Design outcomes

Primary

MeasureTime frame
Side effects after SARS-CoV-2 vaccination;HIV viral load;SARS-CoV-2 neutralizing antibody;CD4+T cell count;

Secondary

MeasureTime frame
Inhibitory /Cytotoxic T lymphocytes;

Countries

China

Contacts

Public ContactJunjie Xu

The First Affiliated Hospital of China Medical University

xjjcmu@163.com+86 15002476278

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026