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NCT06731127
Vaccines in a Time of Dual Pandemic: COVID-19 Vaccine in People With HIV
trial in HIV Infections in 75 participants. Completed in 1 December 2022.
1 December 2022
Quick facts
| Lead sponsor | University of Toronto |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 75 |
| Start date | 10 April 2021 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 1 location across Canada |
Conditions studied
- HIV Infections — all drugs for HIV Infections →
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.
Verify or expand the search:
- PubMed search for NCT06731127
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06731127 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Toronto
- Last refreshed: 2 December 2025
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.
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