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

NCT06731127 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2025-12-02

No results posted yet for this study

Summary

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

Conditions

  • HIV Infections

Sponsors & Collaborators

  • University of Toronto

    lead OTHER

Principal Investigators

  • Mario Ostrowski, MD · University of Toronto

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-10
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • Canada

Study Locations

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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 NCT06731127 on ClinicalTrials.gov