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Immunogenicity of COVID-19 Vaccination in PLWH

NCT ID: NCT04894448

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-10

Study Completion Date

2023-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PLWH

HIV positive

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Any COVID-19 vaccine (1 or more doses)

Control

HIV negative

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Any COVID-19 vaccine (1 or more doses)

Interventions

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COVID-19 Vaccine

Any COVID-19 vaccine (1 or more doses)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Signs or symptoms of active COVID-19 infection
* For HIV-uninfected persons: immune-compromising conditions or on medication which suppresses the immune response
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role collaborator

The Ottawa Hospital (TOH)

UNKNOWN

Sponsor Role collaborator

CIHR Canadian HIV Trials Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cecilia Costiniuk, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Curtis Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital (TOH)

Aslam Anis, PhD

Role: PRINCIPAL_INVESTIGATOR

CIHR Canadian HIV Trials Network

Locations

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The Ottawa Hospital (TOH)

Ottawa, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

University Health Network (UHN)

Toronto, Ontario, Canada

Site Status RECRUITING

Chronic Viral Illness Service (CVIS) McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Lianne Thai

Role: primary

[email protected]
416-340-4800 ext. 2240

Florian Bobeuf

Role: primary

[email protected]
514.934-1934 ext. 32225

References

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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.

Reference Type DERIVED
PMID: 37534695 (View on PubMed)

Costiniuk 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.

Reference Type DERIVED
PMID: 36476452 (View on PubMed)

Costiniuk 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.

Reference Type DERIVED
PMID: 34916326 (View on PubMed)

Other Identifiers

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CTN 328

Identifier Type: -

Identifier Source: org_study_id