Immunogenicity of COVID-19 Vaccination in PLWH

Last updated: October 7, 2021
Sponsor: CIHR Canadian HIV Trials Network
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT04894448
CTN 328
  • Ages > 16
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >/=16 years (Sites may choose to only enrol adults based on their provincial ageof majority)
  • HIV positive for HIV group; For HIV negative group, individuals should beimmunocompetent and generally in good health (i.e. participants should not have acondition associated with immunodeficiency nor be receiving immunosuppressantmedication)
  • Receiving at least 1 dose of COVID-19 vaccine, or have received 1 or 2 doses of aCOVID-19 vaccine
  • Able to provide signed, informed consent
  • Able to attend study visits

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 500
Study Start date:
June 10, 2021
Estimated Completion Date:
July 31, 2023

Connect with a study center

  • The Ottawa Hospital (TOH)

    Ottawa, Ontario
    Canada

    Site Not Available

  • University Health Network (UHN)

    Toronto, Ontario
    Canada

    Active - Recruiting

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

    Montreal, Quebec
    Canada

    Active - Recruiting

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