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

Sponsor

Beijing 302 Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05085145

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
People Living With HIV COVID-19 Vaccine	Biological: Coronavirus vaccine	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coronavirus vaccination Patients in the experimental need to accept the coronavirus vaccination	Biological: Coronavirus vaccine Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively

Arm

Intervention/Treatment

Experimental: Coronavirus vaccination

Patients in the experimental need to accept the coronavirus vaccination

Biological: Coronavirus vaccine

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

Outcome Measures

Primary Outcome Measures

The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection [Within 2 months after the first dose of COVID-19 vaccination]
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.
The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection [Within 2 months after the first dose of COVID-19 vaccination]
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.

Secondary Outcome Measures

The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection [Within 13 months after the first dose of COVID-19 vaccination]
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.
The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection [Within 13 months after the first dose of COVID-19 vaccination]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Patients with acute attack of chronic diseases.
Patients have history of convulsion, epilepsy, encephalopathy and psychosis.
Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
Pregnant or lactating women.
Suffering serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
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.
Patients who are receiving immunosuppressants such as glucocorticoid.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing	China	100039

Sponsors and Collaborators

Beijing 302 Hospital

Investigators

Study Director: Shu-juan Li, MD, Beijing 302 Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beijing 302 Hospital

ClinicalTrials.gov Identifier:

NCT05085145

Other Study ID Numbers:

ky-2021-7-6-1

First Posted:

Oct 20, 2021

Last Update Posted:

Oct 20, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Oct 20, 2021