Clinical trial NCT05075070: Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People With HIV Infected
Official title: Immunogenicity and Safety of an Inactivated COVID-19 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: 2021-10-12
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 infected with HIV receive two doses inactivated COVID-19 vaccine
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion criteria:

* Subjects aged ≥18.
* Body temperature \< 37.3 ° C confirmed by clinical examination before enrollment .
* 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.

Exclusion criteria for the first dose:

* 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.
* 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.
* Other subjects whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.

Exclusion criteria for the second dose:

* Subjects who had vaccine-related adverse reactions after the first dose.
* Having high fever (axillary temperature ≥39.0℃) for three days after the first dose of inoculation, or severe allergic reaction.
* Having any adverse nervous system reaction after the first dose.
* During the acute onset of a chronic disease, or the recovery of acute complications less than two weeks.
* Subjects with severe immunodeficiency (CD4+ count less than 50/ul).
* Acute HIV infection and opportunistic infection.
* Subjects with co-opportunistic infections who did not receive antiviral therapy.
* HIV-infected subjects undergoing treatment with severe drug interactions and overlapping toxicity (kidney damage, liver damage, hematological problems, etc.).
* Other reasons for exclusion considered by the investigator.

Primary outcomes:
measure: Seroconversion rate
timeFrame: 28 days after the 2th dose (Day 49)
measure: Baseline neutralizing antibody level
timeFrame: Before vaccination (Day 0)
measure: Neutralizing antibody level
timeFrame: 28 days after the 2th dose(Day 49)
Secondary outcomes:
measure: Adverse events rate
timeFrame: 0-21days following vaccinations
measure: Serious adverse event rate
timeFrame: 0-6 months
measure: Baseline T cell count
timeFrame: before vaccination (Day 0)
measure: Baseline HIV viral load
timeFrame: before vaccination (Day 0)
measure: T cell count
timeFrame: 28 days after the 2th dose (Day 49)
measure: HIV viral load
timeFrame: 28 days after the 2th dose (Day 49)
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: