Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HIV infenction/AIDS experimental group |
Biological: Biological/Vaccine: SARS-COV-2 VACCINE
The antibody titer and adverse reactions were observed.
|
| Healthy population Control group |
Biological: Biological/Vaccine: SARS-COV-2 VACCINE
The antibody titer and adverse reactions were observed.
|
Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events after injection [1 month after vaccination]
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
- Number of participants with adverse events after injection [3 months after vaccination]
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
- Number of participants with adverse events after injection [6 months after vaccination]
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Secondary Outcome Measures
- Titer and duration of COVID-19 antibody production after vaccination [1 month after vaccination]
The titer and duration of COVID-19 antibody were produced at 1 month
- Titer and duration of COVID-19 antibody production after vaccination [3 months after vaccination]
The titer and duration of COVID-19 antibody were produced at 3 months
- Titer and duration of COVID-19 antibody production after vaccination [6 months after vaccination]
The titer and duration of COVID-19 antibody were produced at 6 months
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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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:
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Previous confirmed case of COVID-19
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confirmed contact history of COVID-19
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vaccination contraindications.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China | Chongqing | China |
Sponsors and Collaborators
- The Second Affiliated Hospital of Chongqing Medical University
Investigators
- Principal Investigator: Hong Ren, PHD, The Second Affiliated Hospital of Chongqing Medical University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
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- Treskova-Schwarzbach M, Haas L, Reda S, Pilic A, Borodova A, Karimi K, Koch J, Nygren T, Scholz S, Schönfeld 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. Review.
- 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. 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.
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