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

NCT05043129 | Unknown

• 1 other identifier: 2021-43
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Covid19

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Titer and duration of COVID-19 antibody production after vaccination

  1 month after vaccination

• Titer and duration of COVID-19 antibody production after vaccination

  3 months after vaccination

• Titer and duration of COVID-19 antibody production after vaccination

  6 months after vaccination

Study Arms (2)

HIV infenction/AIDS

experimental group

Biological: Biological/Vaccine: SARS-COV-2 VACCINE

Healthy population

Control group

Biological: Biological/Vaccine: SARS-COV-2 VACCINE

Interventions

Biological/Vaccine: SARS-COV-2 VACCINE BIOLOGICAL

The antibody titer and adverse reactions were observed.

HIV infenction/AIDS; Healthy population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV infected persons vaccinated with COVID-19 vaccine

You may qualify if:

• 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

You may not qualify if:

• Previous confirmed case of COVID-19
• confirmed contact history of COVID-19
• vaccination contraindications.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

China

Chongqing, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 32085846 BACKGROUND

• 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.

  PMID: 32702299 BACKGROUND

• 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.

  PMID: 33725432 BACKGROUND

• 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.

  PMID: 34272508 BACKGROUND

• 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.

  PMID: 34446016 BACKGROUND

• 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.

  PMID: 35369854 DERIVED

MeSH Terms

Conditions

HIV Infections; COVID-19

Interventions

Biological Products; COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures; Viral Vaccines; Vaccines

Study Officials

• Hong Ren, PHD

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHUAN DA CAI, PHD

CONTACT

18323409779; 597521685@qq.com

DAZHI ZHANG, PHD

CONTACT

13452382818; dzhzhang@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr/ Prof.

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 14, 2021
• Study Start: September 4, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 4, 2022
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)