Clinical trial NCT05495906: A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
Official title: A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: HPV
Human Papilloma Virus
Human Immunodeficiency Virus
Keywords: HPV vaccination
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Anti-HPV16/18 geometric mean titers (GMTs) at month 7
timeFrame: Month 7
Secondary outcomes:
measure: Anti-HPV16/18 GMTs at month 24 in both groups (i.e. routine and extended interval)
timeFrame: Month 24
measure: Quantitative summarization of survey responses regarding vaccine acceptability, comfort, and willingness to use HPV self-sampling as a screening methodology in future
timeFrame: Month 24
Other outcomes:
measure: 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)
timeFrame: Month 7
measure: Anti-HPV16/18 GMTs at month 6 (one-dose data) in the extended vaccine schedule group
timeFrame: Month 6
measure: Incidence, type, and severity of 9vHPV significant adverse events in WLWH
timeFrame: Month 24
measure: Incidence rates of abnormal cervical cytology and histology, and breakthrough persistent HPV infection
timeFrame: Month 24
measure: Peak anti-HPV16/18 GMTs to 1 dose at month 1
timeFrame: Month 1
measure: Viral and bacterial co-infection in the development of cervical dysplasia and vaccine breakthrough HPV infection in WLWH
timeFrame: Month 0-24
measure: Uptake of HPV vaccination in WLWH aged 18-45 across Canada prior to study
timeFrame: Month 0
Locations:
city: Surrey
country: Canada
facility: Positive Health Services - Fraser Health
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Québec
country: Canada
facility: Centre Hospitalier de l'Université Laval
state: Quebec
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
Study officials:
References: