A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV (NCT05495906)
🩺 Plain-English Summary (8th-Grade Level)
There are very little data on human papillomavirus (HPV) vaccination among the 18 million women living with HIV (WLWH) globally, who constitute a population most vulnerable to HPV and the resultant cervical cancer. Particularly, there are no data to date on reduced-dose schedules of nonavalent HPV (9vHPV) vaccination in WLWH and there are very little data on the 9vHPV vaccine in this population overall. It is critical to examine the 9vHPV vaccine in WLWH now because the quadrivalent HPV (4vHPV) vaccine has been discontinued. Additionally, in order to reach the World Health Organization's global goal of cervical cancer elimination, we must determine the role of various HPV prevention strategies in this important population including reduced vaccine dosing which can drastically increase the feasibility of HPV vaccination programs globally. This randomized clinical trial will enrol WLWH aged 18-45 from across Canada who have not previously received an HPV vaccine. Participants will be randomized 1:1 to receive 3 doses of 9vHPV vaccine at the routine vaccine schedule of 0/2/6 months or 2 doses at an expanded schedule of 0/6 months with a third dose at month 12 to adhere to current recommendations for WLWH. We will compare the immune response generated to two versus three doses of 9vHPV vaccine and will follow participants for 2 years to examine the immune response over time. This study, which builds upon our team's prior work on HPV vaccination in WLWH, will determine whether two doses of 9vHPV vaccine can be used in WLWH instead of three, and will examine additional aspects of HPV vaccination in WLWH including the immune response to three doses, vaccine safety and efficacy, and attitudes towards self-collected HPV samples in this population. These data will inform global public health policy and programming and will inform the global strategy for cervical cancer elimination.
Who can join: Review the eligibility criteria below.
Location: Positive Health Services - Fraser Health — Surrey, British Columbia
Age range: 18 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- Positive Health Services - Fraser Health — Surrey, British Columbia
- University of British Columbia — Vancouver, British Columbia
- Health Sciences Centre — Winnipeg, Manitoba
- Hamilton Health Sciences — Hamilton, Ontario
- St. Michael's Hospital — Toronto, Ontario
- Toronto General Hospital — Toronto, Ontario
- Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec
- McGill University Health Centre — Montreal, Quebec
- Centre Hospitalier de l'Université Laval — Québec, Quebec
- Regina General Hospital — Regina, Saskatchewan
📞 Contact the Study Coordinator
Phone: (604) 875-2194
Email: deborah.money@ubc.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HPV
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- SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening — Birmingham, Alabama
- Self-sampling for HPV Screening — Sherbrooke, Quebec
- Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening — Austin, Texas
- A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer — Basking Ridge, New Jersey
- Playing Game to Learn About Children's Vaccine Project — Chandler, Arizona
Explore by condition: All HPV clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.