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

Study Overview
=================
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.

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

Conditions
-----------------
HPV, Human Papilloma Virus, Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Biological: Nonavalent HPV vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine schedule<br>Three doses of 9vHPV vaccine at the routine dosing schedule of 0/2/6 months | Biological: Nonavalent HPV vaccine<br>* Routine dosing form and dosage<br>* Other names: Gardasil9;|
| Experimental: Extended schedule<br>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<br>* Routine dosing form and dosage<br>* 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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HPV16/18 GMTs at month 7 in Group 1 compared with month 13 in Group 2 (1 month post 3rd dose in both groups) |  | Month 7 & 13 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV vaccination