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

NCT05495906 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: H22-01707
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 10

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.

Conditions

Human Papilloma Virus; HPV; Human Immunodeficiency Virus

Keywords

HPV vaccination

Outcome Measures

Primary Outcomes (1)

• Anti-HPV16/18 geometric mean titers (GMTs) at 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)

  Month 7

Secondary Outcomes (2)

• 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

Other Outcomes (7)

• Anti-HPV6/11/31/33/45/52/58 GMTs at month 7 (1 month post 3rd dose in Group 1 and 1 month post 2nd dose in Group 2)

  Month 7

• Anti-HPV16/18 GMTs at month 6 (one-dose data) in the extended vaccine schedule group

  Month 6

• Incidence, type, and severity of 9vHPV significant adverse events in WLWH

  Month 24

Study Arms (2)

Routine schedule

ACTIVE COMPARATOR

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

Biological: Nonavalent HPV vaccine

Extended schedule

EXPERIMENTAL

Two doses of 9vHPV vaccine at an expanded dosing schedule of 0/6 months with a third dose given at month 12

Biological: Nonavalent HPV vaccine

Interventions

Nonavalent HPV vaccine BIOLOGICAL

Routine dosing form and dosage

Also known as: Gardasil9

Extended schedule; Routine schedule

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Living with HIV
• Has a uterine cervix

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (10)

Positive Health Services - Fraser Health

Surrey, British Columbia, V3T 0G9, Canada

NOT YET RECRUITING

University of British Columbia

Vancouver, British Columbia, V6H 2N1, Canada

RECRUITING

Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

NOT YET RECRUITING

Hamilton Health Sciences

Hamilton, Ontario, L8S1A4, Canada

NOT YET RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

RECRUITING

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

NOT YET RECRUITING

Centre Hospitalier de l'Université Laval

Québec, Quebec, G1V4G2, Canada

RECRUITING

Regina General Hospital

Regina, Saskatchewan, S4P0W5, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Deborah Money, MD

CONTACT

6048752194; deborah.money@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: July 27, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CA (10)