Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With HIV Infected

Phase 4

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

• Registration Number: NCT05105295
• Lead Sponsor: China National Biotec Group Company Limited

Brief Summary

Evaluation of immunogenicity, safety and persistence of the subjects with HIV infected received the third dose of inactivated COVID-19 vaccine .

Detailed Description

The subjects aged ≥18 years with HIV infected who have completed the schedule of two doses for 3 months recruited to receive a third dose of inactivated COVID-19 vaccine.

Blood samples will be collected 3 times: before the third dose of vaccinatioin，28 days and 6 months after the third 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: 2021-10-22
• Study First Submitted QC: 2021-10-22
• Last Update Submitted: 2021-10-22
• Study First Posted: 2021-11-03
• Last Update Posted: 2021-11-03
• Study Start: 2021-12
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

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

Inclusion Criteria

• Subjects aged ≥18.
• Body temperature < 37.3 ° C confirmed by clinical examination before enrollment .
• Subjects who meet the diagnostic criteria for HIV infection and AIDS.
• CD4+ count is less than 500/ul and more than 50/ul .
• Female subjects of reproductive age declare that they are not pregnant, have no birth plan in the first 3 months after enrollment, and have taken effective contraceptive measures in the first 2 weeks before enrollment.
• Able and willing to complete the entire study plan during the study follow-up period.
• Have the ability to understand the study procedures, voluntarily sign informed consent, and comply with the requirements of the clinical study protocol.
• Subjects participating in the past clinical trial have completed two doses of COVID-19 vaccine and blood collection before and after immunization;

Exclusion Criteria

• Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons.
• Being allergic to any component of vaccines (including excipients) .
• Subjects who have experienced severe allergic reactions to vaccines (e.g. acute anaphylaxis, urticaria, angoneeurotic edema, dyspnea, etc.).
• Having uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome.
• Injection of non-specific immunoglobulin within 1 month before enrollment.
• Pregnant and lactating women.
• The subjects are suffering from an acute illness; Or thrombocytopenia patients with platelet count < 20×10^9/L within three days before inoculation, that is, patients at high risk of spontaneous bleeding.
• Acute HIV infection and opportunistic infection.
• Subjects with co-opportunistic infections who did not receive antiviral therapy.
• Subjects with CD4+ count less than 50/ul who have not received antiviral therapy.
• HIV-infected subjects undergoing treatment with severe drug interactions and overlapping toxicity (kidney damage, liver damage, hematological problems, etc.).
• Patients with malignant tumors are undergoing chemotherapy and radiotherapy before and after surgery.
• Subjects who had vaccine-related adverse reactions after the second dose.
• Having high fever (axillary temperature ≥39.0℃) for three days after the second dose of inoculation, or severe allergic reaction.
• Having any adverse nervous system reaction after the second dose.
• Other subjects whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	Inactivated COVID-19 vaccine	Subjects receive a third dose of inactivated COVID-19 vaccine

Primary Outcome Measures

Name	Time	Method
Seroconversion rate	28 days after the 3th dose (Day 28)	The rate of seroconversion against coronavirus
Neutralizing antibody level	6 months after the 3th dose	Neutralizing antibody GMT against coronavirus after the 3th dose

Secondary Outcome Measures

Name	Time	Method
Serious adverse event rate	0-6 months	Report and analyse serious adverse events
T cell count	28 days after the 3th dose (Day 28)	T cell count （CD4+T，CD8+T，etc.）
HIV viral load	28 days after the 3th dose (Day 28)	HIV viral load
Adverse events rate	0-21days following vaccinations	Analyse the incidence of adverse events following vaccination, both solicited and unsolicited

Trial Locations

Locations (1)

Zhejiang provincial center for disease control and prevention; 🇨🇳 Hangzhou, Zhejiang, China