A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV (NOVA-HIV)

February 3, 2026 updated by: Deborah Money, University of British Columbia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

275

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 0G9
        • Not yet recruiting
        • Positive Health Services - Fraser Health
        • Contact:
        • Principal Investigator:
          • Michael Chapman, MD
      • Vancouver, British Columbia, Canada, V6H 2N1
        • Recruiting
        • University of British Columbia
        • Contact:
        • Principal Investigator:
          • Deborah Money, MD
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A1R9
        • Not yet recruiting
        • Health Sciences Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vanessa Poliquin, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8S1A4
        • Not yet recruiting
        • Hamilton Health Sciences
        • Contact:
          • Mariana Rusler, BSc Psych., CCRA
          • Phone Number: 73443 905-521-2100
          • Email: rusler@hhsc.ca
        • Principal Investigator:
          • Shariq Haider, MD
      • Toronto, Ontario, Canada, M5B1W8
      • Toronto, Ontario, Canada, M5G2C4
        • Recruiting
        • Toronto General Hospital
        • Principal Investigator:
          • Sharon Walmsley, MD
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3T1C5
      • Montreal, Quebec, Canada, H4A3J1
      • Québec, Quebec, Canada, G1V4G2
        • Recruiting
        • Centre Hospitalier de l'Universite Laval
        • Contact:
        • Contact:
          • Geneviève Gagnon, R.N.
          • Phone Number: 48914 418-525-4444
        • Principal Investigator:
          • Marie-Louise Vachon, MD
    • Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Routine schedule
Three doses of 9vHPV vaccine at the routine dosing schedule of 0/2/6 months
Biological: Nonavalent HPV vaccine
Routine dosing form and dosage
Other Names:
  • Gardasil9
Experimental: Extended schedule
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
Routine dosing form and dosage
Other Names:
  • Gardasil9

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-HPV16/18 geometric mean titers (GMTs) at month 7
Time Frame: 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 Outcome Measures

Outcome Measure
Time Frame
Anti-HPV16/18 GMTs at month 24 in both groups (i.e. routine and extended interval)
Time Frame: Month 24
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
Month 24

Other Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: Month 7
Month 7
Anti-HPV16/18 GMTs at month 6 (one-dose data) in the extended vaccine schedule group
Time Frame: Month 6
Month 6
Incidence, type, and severity of 9vHPV significant adverse events in WLWH
Time Frame: Month 24
Month 24
Incidence rates of abnormal cervical cytology and histology, and breakthrough persistent HPV infection
Time Frame: Month 24
Month 24
Peak anti-HPV16/18 GMTs to 1 dose at month 1
Time Frame: Month 1
Month 1
Viral and bacterial co-infection in the development of cervical dysplasia and vaccine breakthrough HPV infection in WLWH
Time Frame: Month 0-24
Month 0-24
Uptake of HPV vaccination in WLWH aged 18-45 across Canada prior to study
Time Frame: Month 0
Month 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H22-01707

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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