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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-27

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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HPV Human Papilloma Virus Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Routine schedule

Three doses of 9vHPV vaccine at the routine dosing schedule of 0/2/6 months

Group Type ACTIVE_COMPARATOR

Nonavalent HPV vaccine

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

Nonavalent HPV vaccine

Intervention Type BIOLOGICAL

Routine dosing form and dosage

Interventions

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Nonavalent HPV vaccine

Routine dosing form and dosage

Intervention Type BIOLOGICAL

Other Intervention Names

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Gardasil9

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Deborah Money

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Positive Health Services - Fraser Health

Surrey, British Columbia, Canada

Site Status NOT_YET_RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

Site Status RECRUITING

Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status NOT_YET_RECRUITING

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status NOT_YET_RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Toronto General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Centre Hospitalier de l'Université Laval

Québec, Quebec, Canada

Site Status RECRUITING

Regina General Hospital

Regina, Saskatchewan, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Deborah Money, MD

Role: CONTACT

6048752194

Facility Contacts

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Henry Payette, BSc

Role: primary

Deborah Money, MD

Role: primary

6048752194

Emma Karlsen, BSc

Role: backup

604-875-2424 ext. 6379

Dozie Ochular

Role: primary

204-975-7723

Sudharsana R Ande, PhD

Role: backup

204-975-7723

Mariana Rusler, BSc Psych., CCRA

Role: primary

905-521-2100 ext. 73443

Klaudia Szczech, MSc

Role: primary

416-867-7460 ext. 49092

Arifa Rahman, M.B.B.S, MPH

Role: backup

416-867-7460 ext. 48047

Adriana D'Aquila, R.N.

Role: primary

416-340-4800 ext. 8170

Hasna Meddour

Role: primary

514-345-4931 ext. 7169

Suzanne Taillefer, PhD

Role: backup

Nathalie Paisible, R.N.

Role: primary

514-934-1934 ext. 32537

Hansi Peiris

Role: backup

514-934-1934 ext. 32547

Isabelle Chabot

Role: primary

418-525-4444 ext. 47778

Geneviève Gagnon, R.N.

Role: backup

418-525-4444 ext. 48914

Danielle Myrah, RN, BScN

Role: primary

306-766-3915

Sarah Craddock, CHIM

Role: backup

306-766-0576

Other Identifiers

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H22-01707

Identifier Type: -

Identifier Source: org_study_id

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