Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People With HIV Infected

China National Biotec Group (CNBG)

Status and phase

Unknown

Phase 4

Conditions

COVID-19

HIV Infections

Treatments

Biological: Inactivated COVID-19 vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05075070

BIBP2021HIV

Details and patient eligibility

About

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 .

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.