Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People With HIV Infected

Phase 4

• Conditions: COVID-19; HIV Infections

• 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.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-06
• Study Start: 2021-10-08
• Study First Posted: 2021-10-12
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-22
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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