Immunogenicity of COVID-19 Vaccination in PLWH
HIV-COV
Immunogenicity Outcomes in People Living With HIV Following Vaccination for COVID-19 (HIV-COV)
1 other identifier
observational
500
1 country
3
Brief Summary
Various facts support the study of COVID-19 vaccine immunogenicity in People Living With HIV (PLWH) at this time: (1) Many PLWH in Canada will be eligible to receive COVID-19 vaccination as they are in a high priority risk group, such as residents or staff of shared living facilities for seniors, health care workers with direct patient contact, aged 70 years of age or older, or adults in Indigenous communities; (2) As vaccines against many other pathogens, it is plausible that the current standard vaccination strategy of COVID-19 is less effective in PLWH; (3) The potential burden of significant COVID-19 infection in PLWH is likely large given many PLWH are aging and have co-morbidities known to predispose to worse COVID-19 outcomes; (4) The vaccine clinical trials which include PLWH63, have stringent exclusion criteria, making results non-generalizable to many PLWH such as those with lower CD4 counts. With the rapid roll-out of COVID-19 vaccination, many PLWH will be receiving the COVID-19 vaccine. Through vaccination, the provision of the same dosage of antigen stimulation to all individuals will result in a controlled method to measure immune response in PLWH. Therefore, we propose to develop a pan-Canadian cohort of PLWH receiving a COVID-19 vaccine(s) to assess a spectrum of immune responses. We also aim to assess the safety and tolerability of the COVID-19 vaccines in PLWH. These data may provide support for the use of one vaccine product over another and for exploring alternate vaccination strategies in PLWH (i.e., increased dose or double-dose vaccination and so forth).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Start
First participant enrolled
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedOctober 15, 2021
October 1, 2021
10 months
May 18, 2021
October 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
immunogenicity of COVID-19 vaccination
as assessed by COVID-19-specific IgG ELISA 6 months following vaccination
6 months
Secondary Outcomes (4)
Percentage of individuals with COVID-19-specific IgG
12 months
Percentage of persons whose plasma demonstrate COVID-19 neutralization capacity
12 months
Proportion and activation status of CD4 T cells, CD8 T cells, B cells, natural killer cells and monocytes, pre- and post-vaccination
12 months
Percentage of persons with local or systemic adverse events or use of antipyretic or pain medication within 7 days and 30 days of either first or second injection
7 and 30 days, post-injection
Other Outcomes (3)
Proportion of individuals with COVID-19-specific IgG at 6 months
6 months
Proportion of individuals with COVID-19-specific IgG at 6 months that cross-recognizes S protein variants of interest, including N501Y and/or E484K.
12 months
Proportion of individuals with COVID-19-specific T cell responses at 6 months, stratified by HLA genotype and immunodominant epitopes in S protein.
12 months
Study Arms (2)
PLWH
HIV positive
Control
HIV negative
Interventions
Eligibility Criteria
PLWH and HIV negative controls who have received at least one dose of COVID-19 vaccine
You may qualify if:
- Age \>/=16 years (Sites may choose to only enrol adults based on their provincial age of majority)
- HIV positive for HIV group; For HIV negative group, individuals should be immunocompetent and generally in good health (i.e. participants should not have a condition associated with immunodeficiency nor be receiving immunosuppressant medication)
- Receiving at least 1 dose of COVID-19 vaccine, or have received 1 or 2 doses of a COVID-19 vaccine
- Able to provide signed, informed consent
- Able to attend study visits
You may not qualify if:
- Signs or symptoms of active COVID-19 infection
- For HIV-uninfected persons: immune-compromising conditions or on medication which suppresses the immune response
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The Ottawa Hospital (TOH)
Ottawa, Ontario, Canada
University Health Network (UHN)
Toronto, Ontario, Canada
Chronic Viral Illness Service (CVIS) McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Related Publications (3)
Costiniuk CT, Singer J, Lee T, Galipeau Y, McCluskie PS, Arnold C, Langlois MA, Needham J, Jenabian MA, Burchell AN, Samji H, Chambers C, Walmsley S, Ostrowski M, Kovacs C, Tan DHS, Harris M, Hull M, Brumme ZL, Lapointe HR, Brockman MA, Margolese S, Mandarino E, Samarani S, Vulesevic B, Lebouche B, Angel JB, Routy JP, Cooper CL, Anis AH; COVAXHIV Study Group. Antibody neutralization capacity after coronavirus disease 2019 vaccination in people with HIV in Canada. AIDS. 2023 Oct 1;37(12):F25-F35. doi: 10.1097/QAD.0000000000003680. Epub 2023 Aug 2.
PMID: 37534695DERIVEDCostiniuk CT, Singer J, Lee T, Langlois MA, Arnold C, Galipeau Y, Needham J, Kulic I, Jenabian MA, Burchell AN, Shamji H, Chambers C, Walmsley S, Ostrowski M, Kovacs C, Tan DHS, Harris M, Hull M, Brumme ZL, Lapointe HR, Brockman MA, Margolese S, Mandarino E, Samarani S, Vulesevic B, Lebouche B, Angel JB, Routy JP, Cooper CL, Anis AH; COVAXHIV Study Group. COVID-19 vaccine immunogenicity in people with HIV. AIDS. 2023 Jan 1;37(1):F1-F10. doi: 10.1097/QAD.0000000000003429. Epub 2022 Nov 18.
PMID: 36476452DERIVEDCostiniuk CT, Singer J, Langlois MA, Kulic I, Needham J, Burchell A, Jenabian MA, Walmsley S, Ostrowski M, Kovacs C, Tan D, Harris M, Hull M, Brumme Z, Brockman M, Margolese S, Mandarino E, Angel JB, Routy JP, Anis AH, Cooper C. CTN 328: immunogenicity outcomes in people living with HIV in Canada following vaccination for COVID-19 (HIV-COV): protocol for an observational cohort study. BMJ Open. 2021 Dec 16;11(12):e054208. doi: 10.1136/bmjopen-2021-054208.
PMID: 34916326DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cecilia Costiniuk, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
- PRINCIPAL INVESTIGATOR
Curtis Cooper, MD
The Ottawa Hospital (TOH)
- PRINCIPAL INVESTIGATOR
Aslam Anis, PhD
CIHR Canadian HIV Trials Network
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2021
First Posted
May 20, 2021
Study Start
June 10, 2021
Primary Completion
March 31, 2022
Study Completion
July 31, 2023
Last Updated
October 15, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
Data will be shared with Canada's COVID-19 Immunity Task Force (CITF) in accordance with the CITF data sharing agreement. Coded participant data (core data elements: demographics, COVID-19 infection history, health conditions, vaccination, blood testing results) will be deposited into the CITF database every two months for future research concerning COVID-19 and related health outcomes. To request coded centralized data, researchers apply to the CITF Data Access Committee (DAC). The DAC will ask researchers to confirm their intended research activities have received necessary ethics approvals.