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The safety, immunogenicity and antiretroviral therapy effects of COVID-19 inactivated vaccine in HIV-infected patients: a prospective cohort study

The safety, immunogenicity and antiretroviral therapy effects of COVID-19 inactivated vaccine in HIV-infected patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047769
Enrollment
Unknown
Registered
2021-06-26
Start date
2021-07-01
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Case series:No
Control group:No

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Exposure group: HIV-infected subjects who received the new crown vaccine: (1) HIV antibody positive by Western blotting and a report of HIV diagnosis; (2) Aged 18 to 65 years; (3) Received two doses of Kexings new crown vaccine recently, and the interval between two doses of vaccine is 3-5 weeks; (4) Within 2-4 weeks of receiving the second dose of Kexings new crown vaccine; (5) Signed a written informed consent for the investigation content and laboratory testing items of this project, and are willing to participate in a 6-month follow-up investigation. 2. Control group: Non-HIV-infected subjects who received the new crown vaccine: (1) Those who are negative for HIV antibodies in the on-site blood HIV rapid test; (2) Aged 18 to 65 years; (3) Received two doses of Kexings new crown vaccine recently, and the interval between two doses of vaccine is 3-5 weeks; (4) Within 2-4 weeks of receiving the second dose of Kexings new crown vaccine; (5) Signed written informed consent for the investigation content and laboratory testing items of this project, and are willing to participate in the 6-month follow-up investigation; (6) Those who match the characteristics (age, gender, ethnicity, and length of time after vaccination) of HIV-infected persons enrolled in this project.

Exclusion criteria

Exclusion criteria: 1. Exposure group: HIV-infected subjects who received the new crown vaccine: (1) Patients with serious mental and neurological diseases; (2) Those with intellectual disabilities or those who cannot communicate effectively with researchers. 2. Control group: Non-HIV-infected subjects who received the new crown vaccine: (1) Patients with serious mental and neurological diseases; (2) Those with intellectual disabilities or those who cannot communicate effectively with researchers.

Design outcomes

Primary

MeasureTime frame
Rate of Adverse Effect;total antibody;neutralizing antibody;

Countries

China

Contacts

Public ContactXu Junjie

Peking University Shenzhen Hospital

xjjluck100@163.com+86 18002490980

Outcome results

None listed

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