Reduced dosing of the HPV vaccine for women living with HIV
A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
This study is testing if a lower dose of the HPV vaccine can effectively protect women living with HIV from HPV and cervical cancer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 275 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of British Columbia Academic / other |
| Locations | 10 sites (Surrey, British Columbia and 9 other locations) |
| Trial ID | NCT05495906 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a reduced-dose schedule of the nonavalent HPV vaccine in women living with HIV, a group that is particularly vulnerable to HPV and cervical cancer. The study aims to enroll women aged 18-45 who have not previously received an HPV vaccine, with the goal of evaluating the feasibility of vaccination programs in this population. By focusing on reduced dosing, the trial seeks to contribute to global efforts to eliminate cervical cancer as outlined by the World Health Organization. Participants will be randomly assigned to receive the vaccine and monitored for outcomes related to HPV prevention.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-45 living with HIV who have not received any HPV vaccine.
Not a fit: Patients who are pregnant, have previously received an HPV vaccine, or have allergies to the vaccine components may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve HPV vaccination rates and cervical cancer prevention among women living with HIV.
How similar studies have performed: While there is limited data on reduced-dose HPV vaccination in women living with HIV, similar studies have shown promise in other populations, making this approach both novel and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Living with HIV * Has a uterine cervix Exclusion Criteria: * 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
Where this trial is running
Surrey, British Columbia and 9 other locations
- Positive Health Services - Fraser Health — Surrey, British Columbia, Canada (Not_yet_recruiting)
- University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)
- Health Sciences Centre — Winnipeg, Manitoba, Canada (Not_yet_recruiting)
- Hamilton Health Sciences — Hamilton, Ontario, Canada (Not_yet_recruiting)
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
- Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada (Recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Not_yet_recruiting)
- Centre Hospitalier de l'Université Laval — Québec, Quebec, Canada (Recruiting)
- Regina General Hospital — Regina, Saskatchewan, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Deborah Money, MD
- Email: deborah.money@ubc.ca
- Phone: 6048752194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.