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

NCT ID: NCT05085145

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-09-01

Brief Summary

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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

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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.

Conditions

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People Living With HIV COVID-19 Vaccine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Coronavirus vaccination

Patients in the experimental need to accept the coronavirus vaccination

Group Type EXPERIMENTAL

Coronavirus vaccine

Intervention Type BIOLOGICAL

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

Interventions

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Coronavirus vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing 302 Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shu-juan Li, MD

Role: STUDY_DIRECTOR

Beijing 302 Hospital

Locations

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The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fu-Sheng G Wang, MD

Role: CONTACT

[email protected]
8610-66933328

Huihuang G Huang, MD

Role: CONTACT

[email protected]
8610-66933471

Facility Contacts

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Fu-Sheng Wang, MD

Role: primary

[email protected]
01066933328

Other Identifiers

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ky-2021-7-6-1

Identifier Type: -

Identifier Source: org_study_id