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NCT06731127

Vaccines in a Time of Dual Pandemic: COVID-19 Vaccine in People With HIV

Completed Last updated 2 December 2025
What this trial tests

trial in HIV Infections in 75 participants. Completed in 1 December 2022.

Timeline
10 April 2021
Primary endpoint
1 December 2022
1 December 2022

Quick facts

Lead sponsorUniversity of Toronto
StatusCompleted
Study typeOBSERVATIONAL
Enrollment75
Start date10 April 2021
Primary completion1 December 2022
Estimated completion1 December 2022
Sites1 location across Canada

Conditions studied

Sponsor

University of Toronto

Who can join

55 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, non-randomized observational study to examine SARS-CoV-2 vaccine immunogenicity, immune activation and HIV reservoirs in people with HIV infection in comparison with HIV-negative individuals, in those aged 55 or more. As Canada is currently rolling out COVID-19 vaccines, the two most imminent vaccines are mRNA vaccines. These are the Pfizer-BioNTech COVID-19 vaccine given 3 weeks apart and the Moderna COVID-19 vaccine given 4 weeks apart. Given the unique storage requirements of these vaccines, it is expected that the Moderna vaccine will be used primarily in primary care clinics such as Maple Leaf Medical Clinic, Toronto. However, the protocol will also allow observational study of individuals being administered with the Pfizer-BioNTech vaccine if it is also available. The investigators predict general availability of both vaccines to the primary care population by March 1, 2021. Vaccination will occur as per clinical and public health guidelines. COVID-19 vaccines will not be administered as a part of this research study. This is a single site longitudinal study where 75 participants in total are followed over 48 weeks with blood draws and saliva sampling. The breakdown of study arms is described here: • PWH Immune responders (n= 35): undetectable viral load for 1+ year, CD4 \>500/uL, CD4/CD8 ratio \>1 including individuals with a historical, low CD4 nadir • PWH Immune non-responders (n= 10): undetectable viral load, CD4 \<350/uL or CD4/CD8 ratio \<0.75 for 1+ year • PWH Low-level viremics (n= 10): low-level viremia (\<1,000 copies/mL) for 1+ year, any CD4, any CD4/CD8 ratio • HIV-negative control (n= 20): age and sex matched

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for HIV Infections

Currently open trials in the same condition.

Other University of Toronto trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06731127.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing