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

COVID-19 Clinical Trial

Official title:

The Efficacy of COVID-19 Vaccine in Patients With HIV Infection，a Prospective and Multicenter Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05085145
• Other study ID #: ky-2021-7-6-1
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2021
• Source: Beijing 302 Hospital
• Contact: Fu-Sheng G Wang, MD
• Phone: 8610-66933328
• Email: fswang302[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• People Living With HIV
• Vaccine

Intervention

Biological:
• Coronavirus vaccine
Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively

Locations

Country	Name	City	State
China	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection	We design a questionnaire for collecting the side effect, answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire. The questionnaire will be collected on each visit, and blood is drawn for laboratory test.	Within 2 months after the first dose of COVID-19 vaccination
Primary	The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection	The titers of anti-SARS-CoV-2 antibodies will be detected on each follow-up time for evaluating the efficacy and persistence of COVID-19 vaccine in patients with HIV infection.	Within 2 months after the first dose of COVID-19 vaccination
Secondary	The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection	We design a questionnaire for collecting the side effect, answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire. The questionnaire will be collected on each visit, and blood is drawn for laboratory test.	Within 13 months after the first dose of COVID-19 vaccination
Secondary	The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection	The titers of anti-SARS-CoV-2 antibodies will be detected on each follow-up time for evaluating the efficacy and persistence of COVID-19 vaccine in patients with HIV infection.	Within 13 months after the first dose of COVID-19 vaccination