Extended schedule for Human Papilloma Virus (HPV)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of British Columbia, Vancouver, Canada
Human Papilloma Virus (HPV)+5 More
Nonavalent HPV vaccine - Biological
Eligibility
18 - 65
Female
What conditions do you have?
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Study 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.

Eligible Conditions

  • Human Papilloma Virus (HPV)
  • Human Immunodeficiency Virus (HIV) Infections
  • HPV

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Human Papilloma Virus (HPV)

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Month 7 & 13

Month 24
Anti-HPV16/18 GMTs at month 24 in both groups (i.e. routine and extended interval)
Incidence rates of abnormal cervical cytology and histology, and breakthrough persistent HPV infection
Incidence, type, and severity of 9vHPV significant adverse events in WLWH
Quantitative summarization of survey responses regarding vaccine acceptability, comfort, and willingness to use HPV self-sampling as a screening methodology in future
Month 6
Anti-HPV16/18 GMTs at month 6 (one-dose data) in the extended vaccine schedule group
Month 7
Anti-HPV16/18 geometric mean titers (GMTs) at month 7
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 & 13
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)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Human Papilloma Virus (HPV)

Trial Design

2 Treatment Groups

Routine schedule
1 of 2
Extended schedule
1 of 2
Active Control
Experimental Treatment

450 Total Participants · 2 Treatment Groups

Primary Treatment: Extended schedule · No Placebo Group · Phase 3

Extended schedule
Biological
Experimental Group · 1 Intervention: Nonavalent HPV vaccine · Intervention Types: Biological
Routine schedule
Biological
ActiveComparator Group · 1 Intervention: Nonavalent HPV vaccine · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 7 & 13

Trial Background

Deborah Money, Principle Investigator
Principal Investigator
University of British Columbia
Closest Location: University of British Columbia · Vancouver, Canada
Photo of Vancouver  1Photo of Vancouver  2Photo of Vancouver  3
2004First Recorded Clinical Trial
3 TrialsResearching Human Papilloma Virus (HPV)
201 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · Female Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are living with HIV.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.