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

Human Immunodeficiency Virus Clinical Trial

— NOVA-HIV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495906
• Other study ID #: H22-01707
• Status: Recruiting
• Phase: Phase 3
• Start date: July 27, 2023
• Est. completion date: August 2026

Study information

• Verified date: March 2024
• Source: University of British Columbia
• Contact: Deborah Money, MD
• Phone: 6048752194
• Email: deborah.money[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: August 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HPV
• Human Immunodeficiency Virus
• Human Papilloma Virus
• Papilloma

Intervention

Biological:
• Nonavalent HPV vaccine
Routine dosing form and dosage

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	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	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Anti-HPV16/18 GMTs at month 6 (one-dose data) in the extended vaccine schedule group		Month 6
Other	Incidence, type, and severity of 9vHPV significant adverse events in WLWH		Month 24
Other	Incidence rates of abnormal cervical cytology and histology, and breakthrough persistent HPV infection		Month 24
Other	Peak anti-HPV16/18 GMTs to 1 dose at month 1		Month 1
Other	Viral and bacterial co-infection in the development of cervical dysplasia and vaccine breakthrough HPV infection in WLWH		Month 0-24
Other	Uptake of HPV vaccination in WLWH aged 18-45 across Canada prior to study		Month 0
Primary	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	Anti-HPV16/18 GMTs at month 24 in both groups (i.e. routine and extended interval)		Month 24
Secondary	Quantitative summarization of survey responses regarding vaccine acceptability, comfort, and willingness to use HPV self-sampling as a screening methodology in future		Month 24