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HIV InfectionsHIV-COVNCT04894448

Immunogenicity of COVID-19 Vaccination in PLWH

An observational study of HIV Infections, run by CIHR Canadian HIV Trials Network at 3 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
HIV Infections
What is being tested?
COVID-19 Vaccine
Type of treatment
Vaccines
How many people
500 participants
Where
3 sitesCanada
Study dates
10 Jun 2021to 31 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: PLWH and HIV negative controls who have received at least one dose of COVID-19 vaccine

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites, 2 recruiting

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

    Montreal, Quebec

    Florian Bobeuf, 514.934-1934 ext. 32225, florian.bobeuf@much.mcgill.ca

    Cecilia C Costiniuk, MD

    Recruiting

  • The Ottawa Hospital (TOH)

    Ottawa, Ontario

    Active, not recruiting

  • University Health Network (UHN)

    Toronto, Ontario

    Lianne Thai, 416-340-4800 ext. 2240, lianne.thai@uhn.ca

    Sharon Walmsley, MD

    Recruiting

Other trials in Canada

About this study

Official title: Immunogenicity Outcomes in People Living With HIV Following Vaccination for COVID-19 (HIV-COV)

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).

Conditions
HIV Infections
Being tested
COVID-19 Vaccine
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVID-19 VaccineBiological

    Any COVID-19 vaccine (1 or more doses)

Study groups in NCT04894448
Study groupRoleWhat they receive
PLWHHIV positive
Receives: Biological: COVID-19 Vaccine
ControlHIV negative
Receives: Biological: COVID-19 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. immunogenicity of COVID-19 vaccination

    as assessed by COVID-19-specific IgG ELISA 6 months following vaccination

    Measured: 6 months

Secondary outcomes (4)

  1. Percentage of individuals with COVID-19-specific IgG

    Percentage of individuals with COVID-19-specific IgG at 12 months

    Measured: 12 months

  2. Percentage of persons whose plasma demonstrate COVID-19 neutralization capacity

    as assessed by a pseudotyped viral infection assay

    Measured: 12 months

  3. Proportion and activation status of CD4 T cells, CD8 T cells, B cells, natural killer cells and monocytes, pre- and post-vaccination

    Proportion and activation status of CD4 T cells, CD8 T cells, B cells, natural killer cells and monocytes, pre- and post-vaccination

    Measured: 12 months

  4. 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

    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

    Measured: 7 and 30 days, post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start10 Jun 2021
  3. Primary completion31 Mar 2022 (estimated)
  4. Study completion31 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04894448
Sponsor's protocol ID
CTN 328
Acronym
HIV-COV
Status last verified
Oct 2021
First submitted
18 May 2021
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37534695

  • 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.

    PubMed 36476452

  • 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.

    PubMed 34916326

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by CIHR Canadian HIV Trials Network at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

immunogenicity of COVID-19 vaccination (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04894448, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.

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