Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People Aged ≥18 Years With HIV Infected

NCT ID: NCT05075044

Last Updated: 2021-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-08
• Study Completion Date: 2022-12-30

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.

Conditions

HIV Infections; COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental Group

A total 400 HIV-infected subjects receive three doses inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively .

Group Type: EXPERIMENTAL

Inactivated COVID-19 vaccine

Intervention Type: BIOLOGICAL

three doses of inactivated COVID-19 vaccine

Interventions

Inactivated COVID-19 vaccine

three doses of inactivated COVID-19 vaccine

Intervention Type: BIOLOGICAL

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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hubei Provincial Center for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

Wuhan Institute of Biological Products Co., Ltd

INDUSTRY

Sponsor Role: collaborator

China National Biotec Group Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xianfeng Zhang

Role: PRINCIPAL_INVESTIGATOR

Hubei Provincial Center for Disease Control and Prevention

Locations

Hubei Center for Disease Control and Prevention

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xianfeng Zhang

Role: CONTACT

hbcdczxf@163.com

(86)17702795737

Facility Contacts

Xuhua GUAN

Role: primary

552371433@qq.com

+86-13871244927

Other Identifiers

WIBP2021HIV

Identifier Type: -

Identifier Source: org_study_id