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UNKNOWNPhase 4NCT05085145

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

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 (CO...

Lead sponsor: Beijing 302 Hospital•1 locations•View source on ClinicalTrials.gov

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Contacts

Fu-Sheng G Wang, MD

CONTACT

8610-66933328 fswang302@163.com

Huihuang G Huang, MD

CONTACT

8610-66933471 hhh302@163.com

Sponsors

Lead Sponsor

Beijing 302 Hospital

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.

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 20, 2021Terms

Trial snapshot

StatusUNKNOWN

PhasePHASE4

Enrollment200

Start dateSep 2021

Last updatedOct 20, 2021

Condition

People Living With HIV COVID-19 Vaccine

Locations shown

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2021Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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