NCT05085145

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 20, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 20, 2021

Last Update Submit

October 18, 2021

Conditions

People Living With HIVCOVID-19Vaccine

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • 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

  • The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection

    Within 13 months after the first dose of COVID-19 vaccination

Study Arms (1)

Coronavirus vaccination

EXPERIMENTAL

Patients in the experimental need to accept the coronavirus vaccination

Biological: Coronavirus vaccine

Interventions

Coronavirus vaccineBIOLOGICAL

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

Coronavirus vaccination

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Shu-juan Li, MD

    Beijing 302 Hospital

    STUDY DIRECTOR

Central Study Contacts

Fu-Sheng G Wang, MD

CONTACT

8610-66933328fswang302@163.com

Huihuang G Huang, MD

CONTACT

8610-66933471hhh302@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2021

First Posted

October 20, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

October 20, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)