Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People Aged ≥18 Years With HIV Infected

Phase 4

• Conditions: HIV Infections; COVID-19
• Interventions: Biological: Inactivated COVID-19 vaccine

• Registration Number: NCT05075044
• Lead Sponsor: China National Biotec Group Company Limited

Brief Summary

Evaluation of immunogenicity and safety of the subjects aged 18 years and above with HIV-infected recruited to receive three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively .

Detailed Description

The subjects aged 18 years and above with HIV-infected were recruited to receive three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively.

Blood samples were collected before the first dose, 28 days after the second dose, before the third dose, 28 days after the third dose and 6 months after the third dose, respectively.

Any local or systemic adverse events that occurred within 21/28 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: 2021-10-20
• Last Update Posted: 2021-10-22
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

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

Arm && Interventions

Group	Intervention	Description
Experimental Group	Inactivated COVID-19 vaccine	A total 400 HIV-infected subjects receive three doses inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively .

Primary Outcome Measures

Name	Time	Method
Seroconversion rate	28 days after the 3th dose (Day 139)	The rate of seroconversion against coronavirus after the third dose of booster immunization
Baseline neutralizing antibody level	Before vaccination (Day 0)	Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
Neutralizing antibody level	6 months after the 3th dose(Day 291)	Neutralizing antibody GMT against coronavirus after the 3th dose

Secondary Outcome Measures

Name	Time	Method
Adverse events rate	0 -21/28 days 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

Trial Locations

Locations (1)

Hubei Center for Disease Control and Prevention; 🇨🇳 Wuhan, Hubei, China