- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05043129
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
September 13, 2021 updated by: Hong Ren, The Second Affiliated Hospital of Chongqing Medical University
On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SARS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19).
People infected with human immunodeficiency virus (HIV) are affected by their underlying diseases and are listed by the World Health Organization (WHO) as a high-risk population of SARS-CoV-2 infection.To evaluate the safety and effectiveness of COVID-19 vaccine in those patients with human immunodeficiency virus infection , and to guide the COVID-19 vaccination more scientifically, reasonably and effectively, this study was carried out.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
People infected with human immunodeficiency virus (HIV), affected by their underlying diseases, are listed by the World Health Organization (WHO) as a high-risk population for SARS-CoV-2 infection..
More attention should be paid to personal protection and disease prevention.
Vaccination of COVID-19 can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality.
The safety and effectiveness of COVID-19 vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively.
The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University.
Patients with contraindications for vaccination will be excluded.
The detected indexes included blood routine test, CD4, HIV virus load, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and HIV infenction people after vaccination ( 1, 3, 6 months after vaccination).
The adverse reactions related to the vaccine were recorded.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: CHUAN DA CAI, PHD
- Phone Number: 18323409779
- Email: 597521685@qq.com
Study Contact Backup
- Name: DAZHI ZHANG, PHD
- Phone Number: 13452382818
- Email: dzhzhang@yahoo.com
Study Locations
-
-
-
Chongqing, China
- Recruiting
- China
-
Contact:
- DAZHI ZHANG, PHD
- Phone Number: 13452382818
- Email: dzhzhang@yahoo.com
-
Contact:
- DACHUAN CAI, PHD
- Phone Number: 18323409779
- Email: 597521685@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
HIV infected persons vaccinated with COVID-19 vaccine
Description
Inclusion Criteria:
- HIV infection group: a. The HIV positive diagnosis is clear; b. 18-80 years old; c. Has been vaccinated against the COVID-19 ; d. Volunteer to participate in the project;
- Healthy control group: a. HIV negative; b. Age 18-80 years old; c. The COVID-19 vaccination has been completed; d. Volunteer to participate in the project
Exclusion Criteria:
- Previous confirmed case of COVID-19
- confirmed contact history of COVID-19
- vaccination contraindications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy population
Control group
|
The antibody titer and adverse reactions were observed.
|
HIV infenction/AIDS
experimental group
|
The antibody titer and adverse reactions were observed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events after injection
Time Frame: 1 month after vaccination
|
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
|
1 month after vaccination
|
Number of participants with adverse events after injection
Time Frame: 3 months after vaccination
|
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
|
3 months after vaccination
|
Number of participants with adverse events after injection
Time Frame: 6 months after vaccination
|
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
|
6 months after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Titer and duration of COVID-19 antibody production after vaccination
Time Frame: 1 month after vaccination
|
The titer and duration of COVID-19 antibody were produced at 1 month
|
1 month after vaccination
|
Titer and duration of COVID-19 antibody production after vaccination
Time Frame: 3 months after vaccination
|
The titer and duration of COVID-19 antibody were produced at 3 months
|
3 months after vaccination
|
Titer and duration of COVID-19 antibody production after vaccination
Time Frame: 6 months after vaccination
|
The titer and duration of COVID-19 antibody were produced at 6 months
|
6 months after vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hong Ren, PHD, The Second Affiliated Hospital of Chongqing Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available. Erratum In: Lancet Respir Med. 2020 Feb 25;:
- Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, Wu SP, Wang Z, Wu XH, Xu JJ, Zhang Z, Jia SY, Wang BS, Hu Y, Liu JJ, Zhang J, Qian XA, Li Q, Pan HX, Jiang HD, Deng P, Gou JB, Wang XW, Wang XH, Chen W. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020 Aug 15;396(10249):479-488. doi: 10.1016/S0140-6736(20)31605-6. Epub 2020 Jul 20.
- Madhi SA, Baillie V, Cutland CL, Voysey M, Koen AL, Fairlie L, Padayachee SD, Dheda K, Barnabas SL, Bhorat QE, Briner C, Kwatra G, Ahmed K, Aley P, Bhikha S, Bhiman JN, Bhorat AE, du Plessis J, Esmail A, Groenewald M, Horne E, Hwa SH, Jose A, Lambe T, Laubscher M, Malahleha M, Masenya M, Masilela M, McKenzie S, Molapo K, Moultrie A, Oelofse S, Patel F, Pillay S, Rhead S, Rodel H, Rossouw L, Taoushanis C, Tegally H, Thombrayil A, van Eck S, Wibmer CK, Durham NM, Kelly EJ, Villafana TL, Gilbert S, Pollard AJ, de Oliveira T, Moore PL, Sigal A, Izu A; NGS-SA Group; Wits-VIDA COVID Group. Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant. N Engl J Med. 2021 May 20;384(20):1885-1898. doi: 10.1056/NEJMoa2102214. Epub 2021 Mar 16.
- Haynes BF. SARS-CoV-2 and HIV-1 - a tale of two vaccines. Nat Rev Immunol. 2021 Sep;21(9):543-544. doi: 10.1038/s41577-021-00589-w. Epub 2021 Jul 16. Erratum In: Nat Rev Immunol. 2021 Aug 4;: Nat Rev Immunol. 2022 Jan;22(1):66.
- Treskova-Schwarzbach M, Haas L, Reda S, Pilic A, Borodova A, Karimi K, Koch J, Nygren T, Scholz S, Schonfeld V, Vygen-Bonnet S, Wichmann O, Harder T. Pre-existing health conditions and severe COVID-19 outcomes: an umbrella review approach and meta-analysis of global evidence. BMC Med. 2021 Aug 27;19(1):212. doi: 10.1186/s12916-021-02058-6.
- Ao L, Lu T, Cao Y, Chen Z, Wang Y, Li Z, Ren X, Xu P, Peng M, Chen M, Zhang G, Xiang D, Cai D, Hu P, Shi X, Zhang D, Ren H. Safety and immunogenicity of inactivated SARS-CoV-2 vaccines in people living with HIV. Emerg Microbes Infect. 2022 Dec;11(1):1126-1134. doi: 10.1080/22221751.2022.2059401.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 4, 2021
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
September 4, 2022
Study Registration Dates
First Submitted
September 10, 2021
First Submitted That Met QC Criteria
September 10, 2021
First Posted (Actual)
September 14, 2021
Study Record Updates
Last Update Posted (Actual)
September 17, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- COVID-19
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 2021-43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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