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

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

Detailed Description
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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.

Official Title
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Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With Human Immunodeficiency Virus Infected

Conditions
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COVID-19, HIV Infections

Intervention / Treatment
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* Biological: Inactivated COVID-19 vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Subjects receive a third dose of inactivated COVID-19 vaccine | Biological: Inactivated COVID-19 vaccine<br>* receive a third dose of inactivated COVID-19 vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate | The rate of seroconversion against coronavirus | 28 days after the 3th dose (Day 28) | 
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus before the 3th dose | Before the 3th dose (Day 0) | 
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 3th dose | 28 days after the 3th dose (Day 28) | 
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 3th dose | 6 months after the 3th dose | 

Secondary Outcome Measures

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