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

University of British Columbia

Status and phase: Enrolling; Phase 4

Conditions: Human Immunodeficiency Virus; HPV; Human Papilloma Virus

Treatments: Biological: Nonavalent HPV vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05495906

H22-01707

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups

Routine schedule

Active Comparator group

Description:

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

Treatment:

Biological: Nonavalent HPV vaccine

Extended schedule

Experimental group

Description:

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

Treatment:

Biological: Nonavalent HPV vaccine