Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection

HIV Infections Clinical Trial

Official title:

Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043129
• Other study ID #: 2021-43
• Status: Recruiting
• Start date: September 4, 2021
• Est. completion date: September 4, 2022

Study information

• Verified date: September 2021
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: CHUAN DA CAI, PHD
• Phone: 18323409779
• Email: 597521685[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 4, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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;

2. 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:

1. Previous confirmed case of COVID-19

2. confirmed contact history of COVID-19

3. vaccination contraindications.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• COVID-19
• Covid19
• HIV Infections
• Infections

Intervention

Biological:
• Biological/Vaccine: SARS-COV-2 VACCINE
The antibody titer and adverse reactions were observed.

Locations

Country	Name	City	State
China	China	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

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;:. — View Citation

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. — View Citation

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. — View Citation

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;:. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events after injection	The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.	1 month after vaccination
Primary	Number of participants with adverse events after injection	The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.	3 months after vaccination
Primary	Number of participants with adverse events after injection	The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.	6 months after vaccination
Secondary	Titer and duration of COVID-19 antibody production after vaccination	The titer and duration of COVID-19 antibody were produced at 1 month	1 month after vaccination
Secondary	Titer and duration of COVID-19 antibody production after vaccination	The titer and duration of COVID-19 antibody were produced at 3 months	3 months after vaccination
Secondary	Titer and duration of COVID-19 antibody production after vaccination	The titer and duration of COVID-19 antibody were produced at 6 months	6 months after vaccination

External Links

•   Interim Guidance for COVID-19 and Persons with HIV