NCT05085145

Immunogenicity and Safety of COVID-19 Vaccine in People Living With HIV

The Efficacy of COVID-19 Vaccine in Patients With HIV Infection，a Prospective and Multicenter Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with HIV may be at higher risk than those without HIV for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of coronavirus vaccine for patients with HIV.

Detailed description

This study is a prospective, single-arm, open-label clinical trial. A total of 200 patients with HIV infection were included in this vaccination study. All of the patients will further accept 12 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.

Conditions

• People Living With HIV
• COVID-19
• Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Coronavirus vaccine	Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-10-20
• Last updated: 2021-10-20

Locations

1 site across 1 country: China