Tests fewer doses of HPV vaccine in women living with HIV
Compares 2 versus 3 doses of HPV vaccine in women with HIV.
Plain-language title generated from the registry record
Registry title: A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
Key facts
- Where
- Hamilton, Montreal, Québec, Regina, Surrey, Toronto, Vancouver, and Winnipeg, CanadaSee the 10 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT05495906, who can take part
Where in Canada
- Hamilton Health SciencesHamilton, CanadaNot yet recruiting
- Centre Hospitalier Universitaire Sainte-JustineMontreal, CanadaTaking people
- McGill University Health CentreMontreal, CanadaNot yet recruiting
- Centre hospitalier de l'Université LavalQuébec, CanadaTaking people
- Regina General HospitalRegina, CanadaNot yet recruiting
- Positive Health Services - Fraser HealthSurrey, CanadaNot yet recruiting
- St. Michael's HospitalToronto, CanadaTaking people
- Toronto General HospitalToronto, CanadaTaking people
- University of British ColumbiaVancouver, CanadaTaking people
- Health Sciences CentreWinnipeg, CanadaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of British Columbia
- Trial code
- NCT05495906
- Record updated
- 5 February 2026
- Original description
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.Read full original descriptionShow less
A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
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.
Inclusion: Living with HIV; Has a uterine cervix.
Exclusion: Prior receipt of any HPV vaccine; Allergy to the vaccine or its components; Unable to give fully informed consent; Pregnant or unwilling to avoid pregnancy during vaccination.