Clinical trial NCT05075044: Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People Aged ≥18 Years With HIV Infected
Official title: Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥18 Years With Human Immunodeficiency Virus Infected
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
COVID-19
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Hubei Provincial Center for Disease Control and Prevention
name: Wuhan 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 three doses inactivated COVID-19 vaccine
Primary purpose: PREVENTION

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.

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.
* Female subjects of childbearing age declare that they are not pregnant, have no birth plan in the first 6 months after enrollment, and have taken effective contraceptive measures within 2 weeks before enrollment, and all the above statements are signed and confirmed; For those who are not known to be pregnant, a negative urine pregnancy test is required to confirm that they are not pregnant.
* 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:

* Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons.
* Subjects have history of vaccination against COVID-19.
* Being allergic to any component of vaccines (including excipients) .
* Having uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome.
* Pregnant and lactating women.
* 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)
measure: Seroconversion rate
timeFrame: 28 days after the 3th dose (Day 139)
measure: Neutralizing antibody level
timeFrame: Before the 3th vaccination (Day 111)
measure: Neutralizing antibody level
timeFrame: 28 days after the 3th dose(Day 139)
measure: Neutralizing antibody level
timeFrame: 6 months after the 3th dose(Day 291)
Secondary outcomes:
measure: Adverse events rate
timeFrame: 0 -21/28 days following vaccinations
measure: Serious adverse event rate
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Center for Disease Control and Prevention
state: Hubei
Study officials:
affiliation: Hubei Provincial Center for Disease Control and Prevention
name: Xianfeng Zhang
role: PRINCIPAL_INVESTIGATOR
References: