Recruiting

COVID-19 Vaccination

Sponsor:

CIHR Canadian HIV Trials Network

Code:

NCT04894448

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

COVID-19 Vaccine

Study Details

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).

Conditions

HIV Infections

Study ID

NCT04894448

Start date

Jun 10, 2021

Status verified date

Oct, 2021

Completion date

Jul 31, 2023

Anticipated

Primary completion date

Mar 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

PLWH

HIV positive

Control

HIV negative

Interventions

COVID-19 Vaccine

Any COVID-19 vaccine (1 or more doses)

Primary outcome measure

  • immunogenicity of COVID-19 vaccination [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

University Health Network (UHN)

Recruiting

Toronto, Ontario, Canada

Contacts

Principal Investigator:

Sharon Walmsley, MD

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

Recruiting

Montreal, Quebec, Canada

Contacts

Principal Investigator:

Cecilia C Costiniuk, MD

More Information

Sponsor

CIHR Canadian HIV Trials Network

Last update posted

Oct 15, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CIHR Canadian HIV Trials Network on 2021-10-15.