Clinical trial NCT05085145: Immunogenicity and Safety of COVID-19 Vaccine in People Living With HIV
Official title: The Efficacy of COVID-19 Vaccine in Patients With HIV Infection，a Prospective and Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: People Living With HIV
COVID-19
Vaccine
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection
timeFrame: Within 2 months after the first dose of COVID-19 vaccination
measure: The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection
timeFrame: Within 2 months after the first dose of COVID-19 vaccination
Secondary outcomes:
measure: The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection
timeFrame: Within 13 months after the first dose of COVID-19 vaccination
measure: The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection
timeFrame: Within 13 months after the first dose of COVID-19 vaccination
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Shu-juan Li, MD
role: STUDY_DIRECTOR
References: