Actively Recruiting
A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
Led by University of British Columbia · Updated on 2026-02-05
275
Participants Needed
10
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the immune response to the nonavalent HPV (9vHPV) vaccine in women living with HIV (WLWH), a group particularly vulnerable to HPV and cervical cancer. There is limited data on reduced-dose schedules of the 9vHPV vaccine in this population, which is important as the previously used quadrivalent HPV vaccine has been discontinued. The study seeks to inform global strategies for cervical cancer elimination by evaluating different dosing schedules in WLWH aged 18 to 45 years. Participants will be randomly assigned to one of two groups: one group will receive three doses of the 9vHPV vaccine following the routine schedule at 0, 2, and 6 months, while the other group will receive two doses at 0 and 6 months, with a third dose at month 12. This design follows current recommendations and allows comparison of immune responses between the routine and extended dosing schedules. During the two-year follow-up, participants will undergo regular assessments to measure immune responses, specifically anti-HPV16/18 antibody levels at months 7 and 24. Researchers will also evaluate vaccine safety, effectiveness, and attitudes toward self-collected HPV samples. Surveys will assess vaccine acceptability and comfort. The study includes monitoring for adverse events and aims to provide data to improve HPV vaccination programs for WLWH globally.
CONDITIONS
Brief Title
A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Living with HIV
- Has a uterine cervix
- Female aged 18 to 45 years
- Has not previously received any HPV vaccine
- Able to give fully informed consent
- Not pregnant and willing to avoid pregnancy during vaccination
You will not qualify if you...
- Unable to give fully informed consent
- Pregnant or unwilling to avoid pregnancy during vaccination
- Allergy to the vaccine or its components
- Prior receipt of any HPV vaccine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months depending on dosing schedule
Participants receive the Nonavalent HPV vaccine according to their assigned dosing schedule.
3 vaccination visits over 12 months for routine schedule or 3 vaccination visits over 12 months for extended schedule
Trial Site Locations
Total: 10 locations
1
Positive Health Services - Fraser Health
Surrey, British Columbia, Canada, V3T 0G9
Not Yet Recruiting
2
University of British Columbia
Vancouver, British Columbia, Canada, V6H 2N1
Actively Recruiting
3
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9
Not Yet Recruiting
4
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8S1A4
Not Yet Recruiting
5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Actively Recruiting
6
Toronto General Hospital
Toronto, Ontario, Canada, M5G2C4
Actively Recruiting
7
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T1C5
Actively Recruiting
8
McGill University Health Centre
Montreal, Quebec, Canada, H4A3J1
Not Yet Recruiting
9
Centre Hospitalier de l'Université Laval
Québec, Quebec, Canada, G1V4G2
Actively Recruiting
10
Regina General Hospital
Regina, Saskatchewan, Canada, S4P0W5
Not Yet Recruiting
Research Team
D
Deborah Money, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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