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Cancer Vaccine

HPV Vaccine for Anal Cancer Prevention

Phase 2

Waitlist Available

Led By Irving Salit, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of any sexual activity with men, or both men and women, where sexual activity is defined as oral, vaginal, or anal intercourse

An ability to attend clinic for all study visits

Must not have

Current or prior history of cancer of the anogenital regions (e.g. penile, anal, or rectal) or of the oropharyngeal area (e.g. oral cavity, upper airway)

Previous HPV immunization.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the safety and efficacy of HPV vaccination in HIV-positive men who have sex with men.

Who is the study for?

This trial is for HIV-positive men who have had sexual activity with men or both genders, are at least 18 years old, and have high-grade anal dysplasia (AIN-2 or -3). They must be willing to undergo standard ablative therapy and either be on a stable antiretroviral regimen or not planning to start one within six months. Participants need documented HIV infection and the ability to attend all study visits.

What is being tested?

The trial is testing the safety and effectiveness of the 9-valent HPV vaccine in preventing recurrence of high-grade anal lesions in HIV-positive MSM. It explores how well this vaccine works as part of their overall health management strategy.

What are the potential side effects?

Potential side effects from the HPV vaccine may include reactions at the injection site like pain, redness, swelling, fatigue, headache, muscle or joint pain. Severe allergic reactions are rare but can occur in those sensitive to ingredients like yeast.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had sexual relations with men or both men and women.

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I can go to all required clinic visits for the study.

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I have been on a stable HIV treatment for at least 6 months with undetectable viral load.

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I have had sexual activity with men or both men and women.

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I have been on a stable HIV treatment for at least 6 months with undetectable viral load.

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I am a man aged 18 or older.

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I am a man aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had cancer in the genital, anal, rectal, or throat areas.

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I have been vaccinated against HPV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of participants in each arm with biopsy-proven HGAIN (AIN-2/3).

Secondary study objectives

The geometric mean titres (GMT) of antibody to each vaccine type above a pre-specified, validated cut-off. F

Other study objectives

Change in anal carriage of vaccine HPV types. Repeated detection of anal HPV will indicate the duration of carriage. This will be compared between the early and delayed vaccine groups.