A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
NCT ID: NCT05495906
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
275 participants
INTERVENTIONAL
2023-07-27
2028-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Routine schedule
Three doses of 9vHPV vaccine at the routine dosing schedule of 0/2/6 months
Nonavalent HPV vaccine
Routine dosing form and dosage
Extended schedule
Two doses of 9vHPV vaccine at an expanded dosing schedule of 0/6 months with a third dose given at month 12
Nonavalent HPV vaccine
Routine dosing form and dosage
Interventions
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Nonavalent HPV vaccine
Routine dosing form and dosage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a uterine cervix
Exclusion Criteria
* Pregnant or unwilling to avoid pregnancy during vaccination
* Allergy to the vaccine or its components
* Prior receipt of any HPV vaccine
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Deborah Money
Principle Investigator
Locations
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Positive Health Services - Fraser Health
Surrey, British Columbia, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre Hospitalier de l'Université Laval
Québec, Quebec, Canada
Regina General Hospital
Regina, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Geneviève Gagnon, R.N.
Role: backup
Other Identifiers
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H22-01707
Identifier Type: -
Identifier Source: org_study_id
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