Clinical trial NCT05105295: Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With HIV Infected
Official title: Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With Human Immunodeficiency Virus Infected
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19
HIV Infections
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Zhejiang Provincial Center for Disease Control and Prevention
name: Beijing Institute of Biological Products Co Ltd.
First posted: 2021-11-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects aged ≥18 with infected with HIV who have completed the schedule of two doses for 3 months receive a third dose of inactivated COVID-19 vaccine.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Seroconversion rate
timeFrame: 28 days after the 3th dose (Day 28)
measure: Neutralizing antibody level
timeFrame: Before the 3th dose (Day 0)
measure: Neutralizing antibody level
timeFrame: 28 days after the 3th dose (Day 28)
measure: Neutralizing antibody level
timeFrame: 6 months after the 3th dose
Secondary outcomes:
measure: Adverse events rate
timeFrame: 0-21days following vaccinations
measure: Serious adverse event rate
timeFrame: 0-6 months
measure: T cell count
timeFrame: before the 3th dose (Day 0)
measure: T cell count
timeFrame: 28 days after the 3th dose (Day 28)
measure: HIV viral load
timeFrame: before the 3th dose (Day 0)
measure: HIV viral load
timeFrame: 28 days after the 3th dose (Day 28)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang provincial center for disease control and prevention
state: Zhejiang
Study officials:
affiliation: Zhejiang Provincial Center for Disease Control and Prevention
name: Hanqing He
role: PRINCIPAL_INVESTIGATOR
References: