Immunogenicity and Safety of COVID-19 Vaccine in People Living With HIV

Beijing 302 Hospital

Status and phase: Unknown; Phase 4

Conditions: COVID-19; Vaccine; People Living With HIV

Treatments: Biological: Coronavirus vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05085145

ky-2021-7-6-1

Details and patient eligibility

About

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with HIV may be at higher risk than those without HIV for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of coronavirus vaccine for patients with HIV.

Full description

This study is a prospective, single-arm, open-label clinical trial. A total of 200 patients with HIV infection were included in this vaccination study. All of the patients will further accept 12 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age above 18 years and less than 60 years
2. Patients diagnosed as HIV infection with viral inhibition or preparing to start antivirus therapy were included .
3. The functions of multi-organs were normal or basically normal, and there are no contraindications for vaccination.

Exclusion criteria

1. Patients with acute attack of chronic diseases.
2. Patients have history of convulsion, epilepsy, encephalopathy and psychosis.
3. Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
4. Pregnant or lactating women.
5. Suffering serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
6. Patients have severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / uroedema.
7. Patients who are receiving immunosuppressants such as glucocorticoid.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Coronavirus vaccination

Experimental group

Description:

Patients in the experimental need to accept the coronavirus vaccination

Treatment:

Biological: Coronavirus vaccine