Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People With HIV Infected
- Conditions
- COVID-19HIV Infections
- Interventions
- Biological: Inactivated COVID-19 vaccine
- Registration Number
- NCT05075070
- Lead Sponsor
- China National Biotec Group Company Limited
- Brief Summary
Evaluation of immunogenicity and safety of the subjects infected with HIV to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days .
- Detailed Description
The subjects infected with HIV were recruited to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days .
Blood samples will be collected 2 times: before the 1st dose of vaccinatioin and 28 days after the 2nd dose of vaccination.
Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Group Inactivated COVID-19 vaccine A total 400 HIV-infected subjects receive two doses inactivated COVID-19 vaccine with the interval of 21 days.
- Primary Outcome Measures
Name Time Method Neutralizing antibody level 28 days after the 2th dose(Day 49) Neutralizing antibody GMT against coronavirus after the 2th dose
Seroconversion rate 28 days after the 2th dose (Day 49) The rate of seroconversion against coronavirus
Baseline neutralizing antibody level Before vaccination (Day 0) Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
- Secondary Outcome Measures
Name Time Method Baseline T cell count before vaccination (Day 0) T cell count （CD4+T，CD8+T，etc.）
Adverse events rate 0-21days following vaccinations Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
Serious adverse event rate 0-6 months Report and analyse serious adverse events
T cell count 28 days after the 2th dose (Day 49) T cell count （CD4+T，CD8+T，etc.）
HIV viral load 28 days after the 2th dose (Day 49) HIV viral load
Baseline HIV viral load before vaccination (Day 0) HIV viral load
Trial Locations
- Locations (1)
Zhejiang provincial center for disease control and prevention
🇨🇳Hangzhou, Zhejiang, China