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Immunogenicity of COVID-19 Vaccination in PLWH

NCT04894448 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2021-10-15

No results posted yet for this 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).

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

COVID-19 Vaccine

Any COVID-19 vaccine (1 or more doses)

Sponsors & Collaborators

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

    collaborator OTHER

  • The Ottawa Hospital (TOH)

    collaborator UNKNOWN

  • CIHR Canadian HIV Trials Network

    lead NETWORK

Principal Investigators

  • Cecilia Costiniuk, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Curtis Cooper, MD · The Ottawa Hospital (TOH)

  • Aslam Anis, PhD · CIHR Canadian HIV Trials Network

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2022-03-31
Completion
2023-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04894448 on ClinicalTrials.gov