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Phase 4Recruiting
View on ClinicalTrials.gov

Testing Nonavalent HPV vaccine for HPV

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

Condition: HPVSponsor: University of British ColumbiaTarget enrollment: 275
  • Phase 4
  • 2 groups
  • Sites in Surrey, Vancouver and 6 more cities
  • Recruiting
Positive Health Services - Fraser Health, Surrey, British ColumbiaHealth Sciences Centre, Winnipeg, ManitobaHamilton Health Sciences, Hamilton, OntarioMcGill University Health Centre, Montreal, QuebecRegina General Hospital, Regina, SaskatchewanUniversity of British Columbia, Vancouver, British ColumbiaSt. Michael's Hospital, Toronto, OntarioToronto General Hospital, Toronto, OntarioCentre Hospitalier Universitaire Sainte-Justine, Montreal, QuebecCentre Hospitalier de l'Université Laval, Québec, Quebec

Interventions

  • Biological therapy

    Nonavalent HPV vaccine

    Routine dosing form and dosage

Canadian Sites (10)

5 of 10 recruiting

  • University of British Columbia

    Vancouver, British Columbia

    Recruiting

  • St. Michael's Hospital

    Toronto, Ontario

    Recruiting

  • Toronto General Hospital

    Toronto, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for6 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Living with HIV
  • +Has a uterine cervix

Exclusion

  • −Allergy to the vaccine or its components
  • −Unable to give fully informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
  • −Prior receipt of any HPV vaccine
  • −Pregnant or unwilling to avoid pregnancy during vaccination
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to prevent a condition from developing.

Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A, the comparison group, receives Nonavalent HPV vaccine.

Registry label: A: Routine schedule

Group B receives Nonavalent HPV vaccine.

Registry label: B: Extended schedule

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 18 years to 45 years.

The study lists female participants only.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 275 people.

The study is currently expected to finish around January 2028.

The main measurement is taken over: Month 7.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Anti-HPV16/18 geometric mean titers (GMTs) at month 7 — measured over Month 7.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05495906 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Nonavalent HPV vaccineBiological

Routine dosing form and dosage

From the trial registry — its own words, unedited.

What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 18 years to 45 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

See how your details line up — get matched
From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

Save this trial to share with your doctor
From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

Save this trial to share with your doctor
From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 18 years to 45 years.

It lists female participants only.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

See how your details line up — get matched
From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Month 7.

The study as a whole is currently expected to finish around 2028-01.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

Ask the study team directly
From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 275 people.

Save this trial to share with your doctor
From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 8 locations, including: Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Hamilton, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 2 more.

Sites can open and close during a study, so confirm with the team before travelling.

Ask the study team directly
From the trial registry
  • trial_locations

About This Trial

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.

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