A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living with HIV

Phase 4

Recruiting

• Conditions: Human Immunodeficiency Virus; HPV; Human Papilloma Virus
• Interventions: Biological: Nonavalent HPV vaccine

• Registration Number: NCT05495906
• Lead Sponsor: University of British Columbia

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Study Start: 2023-07-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-08
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine schedule	Nonavalent HPV vaccine	Three doses of 9vHPV vaccine at the routine dosing schedule of 0/2/6 months
Extended schedule	Nonavalent HPV vaccine	Two doses of 9vHPV vaccine at an expanded dosing schedule of 0/6 months with a third dose given at month 12

Primary Outcome Measures

Name	Time	Method
Anti-HPV16/18 geometric mean titers (GMTs) at month 7	Month 7	Anti-HPV16/18 GMTs at month 7 (1 month post 3rd dose in Group 1 and 1 month post 2nd dose in Group 2)

Secondary Outcome Measures

Name	Time	Method
Anti-HPV16/18 GMTs at month 24 in both groups (i.e. routine and extended interval)	Month 24
Quantitative summarization of survey responses regarding vaccine acceptability, comfort, and willingness to use HPV self-sampling as a screening methodology in future	Month 24

Trial Locations

Locations (10)

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; 🇨🇦 Montréal, Quebec, Canada

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada

Centre Hospitalier de l'Université Laval; 🇨🇦 Québec, Quebec, Canada

Regina General Hospital; 🇨🇦 Regina, Saskatchewan, Canada