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 .
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
400
two doses inactivated COVID-19 vaccine
Zhejiang provincial center for disease control and prevention
Hangzhou, Zhejiang, China
RECRUITINGSeroconversion rate
The rate of seroconversion against coronavirus
Time frame: 28 days after the 2th dose (Day 49)
Baseline neutralizing antibody level
Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
Time frame: Before vaccination (Day 0)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus after the 2th dose
Time frame: 28 days after the 2th dose(Day 49)
Adverse events rate
Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
Time frame: 0-21days following vaccinations
Serious adverse event rate
Report and analyse serious adverse events
Time frame: 0-6 months
Baseline T cell count
T cell count (CD4+T,CD8+T,etc.)
Time frame: before vaccination (Day 0)
Baseline HIV viral load
HIV viral load
Time frame: before vaccination (Day 0)
T cell count
T cell count (CD4+T,CD8+T,etc.)
Time frame: 28 days after the 2th dose (Day 49)
HIV viral load
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HIV viral load
Time frame: 28 days after the 2th dose (Day 49)