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Cancer Vaccine

HPV Vaccine for Anal Cancer Prevention

Q: What is the novelty of this research?

<p>Merck Sharp &#x26; Dohme Corp. first conducted a clinical trial for 9-valent <a href="https://www.withpower.com/clinical-trials/hpv">HPV</a> vaccination in 2002, which completed Phase 3 and received drug approval. Since then, 116 studies have been completed by the corporation and other organizations. As of now, there are 34 active trials being conducted in 131 cities across 32 countries.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Other outcome measures

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate VaccinationExperimental Treatment1 Intervention

Administration of dose #1 of 9-valent HPV vaccination will be given at baseline visit, dose #2 at month 2, and dose #3 at month 6.

Group II: Delayed VaccinationActive Control1 Intervention

Administration of dose #1 of 9-valent HPV vaccination will be given at month 12, dose #2 at month 14, and dose #3 at month 18.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,343 Total Patients Enrolled

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,291 Total Patients Enrolled

Irving Salit, MDPrincipal InvestigatorToronto General Hospital, University Health Network

1 Previous Clinical Trials

71 Total Patients Enrolled

Media Library

9-valent HPV vaccination (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03947775 — Phase 2

Human Papillomavirus Research Study Groups: Delayed Vaccination, Immediate Vaccination

Human Papillomavirus Clinical Trial 2023: 9-valent HPV vaccination Highlights & Side Effects. Trial Name: NCT03947775 — Phase 2

9-valent HPV vaccination (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03947775 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What types of HPV strains does the 9-valent HPV vaccine protect against?

"The 9-valent HPV vaccine is an effective treatment against infections from human papillomavirus type 58 and 31, as well as general HPV infection."

Answered by AI

What is the current government stance on 9-valent HPV vaccination?

"While 9-valent HPV vaccination has only been studied in Phase 2 trials, there is some evidence supporting its safety. However, there is no clinical data yet to suggest that it is an effective medication."

Answered by AI

Are there currently patients participating in this trial?

"Currently, this clinical trial is not looking for new patients as noted onclinicaltrials.gov. This particular study was first posted on September 1st, 2022 and was last updated on June 9th, 2022; however, there are 3,578 other trials that are actively enrolling participants."

Answered by AI

How many people are agreed to participate in this experiment?

"Unfortunately, this study is not presently looking for new candidates. Although, it's possible that the status could change in the future as the trial was most recently updated on 6/9/2022. If you are interested in other studies, there are 3544 trials actively searching for patients with cancer and 34 trials for 9-valent HPV vaccination actively searching for participants."

Answered by AI

Are there other studies that have looked at the 9-valent HPV vaccine?

"At the moment, there are 34 ongoing clinical trials for 9-valent HPV vaccination worldwide. Out of these, 16 are in Phase 3. Bangkok and Chang Wat Nonthaburi are just two of the many locations conducting research on this topic."

Answered by AI

What is the novelty of this research?

"Merck Sharp & Dohme Corp. first conducted a clinical trial for 9-valent HPV vaccination in 2002, which completed Phase 3 and received drug approval. Since then, 116 studies have been completed by the corporation and other organizations. As of now, there are 34 active trials being conducted in 131 cities across 32 countries."

Answered by AI