A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nonavalent HPV vaccine.
- Who it may be relevant to
- Registry conditions: HPV, Human Papilloma Virus, Human Immunodeficiency Virus. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Biological Nonavalent HPV vaccine
Routine dosing form and dosage
Primary outcome measures
- Anti-HPV16/18 geometric mean titers (GMTs) at month 7 [Time frame: Month 7]
Secondary outcome measures (2)
- Anti-HPV16/18 GMTs at month 24 in both groups (i.e. routine and extended interval) [Time frame: Month 24]
- Quantitative summarization of survey responses regarding vaccine acceptability, comfort, and willingness to use HPV self-sampling as a screening methodology in future [Time frame: Month 24]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Canada · 10 centers
- Positive Health Services - Fraser Health — Surrey
- University of British Columbia — Vancouver
- Health Sciences Centre — Winnipeg
- Hamilton Health Sciences — Hamilton
- St. Michael's Hospital — Toronto
- Toronto General Hospital — Toronto
- Centre Hospitalier Universitaire Sainte-Justine — Montreal
- McGill University Health Centre — Montreal
- … and 2 more centers
Identifiers
NCT: NCT05495906 · H22-01707