Back to resultsImmunogenicity and Safety of COVID-19 Vaccine in People Living With HIV
Primary Purpose
People Living With HIV, COVID-19, Vaccine
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Coronavirus vaccine
Sponsored by
About this trial
This is an interventional treatment trial for People Living With HIV
Eligibility Criteria
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.
Sites / Locations
- The Fifth Medical Center of PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Coronavirus vaccination
Arm Description
Patients in the experimental need to accept the coronavirus vaccination
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05085145
Brief Title
Immunogenicity and Safety of COVID-19 Vaccine in People Living With HIV
Official Title
The Efficacy of COVID-19 Vaccine in Patients With HIV Infection，a Prospective and Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing 302 Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
People Living With HIV, COVID-19, Vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Coronavirus vaccination
Arm Type
Experimental
Arm Description
Patients in the experimental need to accept the coronavirus vaccination
Intervention Type
Biological
Intervention Name(s)
Coronavirus vaccine
Intervention Description
Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively
Primary Outcome Measure Information:
Title
The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection
Description
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.
Time Frame
Within 2 months after the first dose of COVID-19 vaccination
Title
The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection
Description
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.
Time Frame
Within 2 months after the first dose of COVID-19 vaccination
Secondary Outcome Measure Information:
Title
The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection
Description
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.
Time Frame
Within 13 months after the first dose of COVID-19 vaccination
Title
The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection
Description
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.
Time Frame
Within 13 months after the first dose of COVID-19 vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fu-Sheng G Wang, MD
Phone
8610-66933328
Email
fswang302@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huihuang G Huang, MD
Phone
8610-66933471
Email
hhh302@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-juan Li, MD
Organizational Affiliation
Beijing 302 Hospital
Official's Role
Study Director
Facility Information:
Facility Name
The Fifth Medical Center of PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fu-Sheng Wang, MD
Phone
01066933328
Email
fswang302@163.com
First Name & Middle Initial & Last Name & Degree
Fu-sheng Wang, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immunogenicity and Safety of COVID-19 Vaccine in People Living With HIV
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