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Cancer Vaccine

HPV Vaccine for Warts

Phase 2 & 3
Recruiting
Led By Lowell Nicholson, MD
Research Sponsored by Western Institute for Veterans Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of cutaneous warts
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up quality of life assessments will occur at 0 (baseline), 4, 8, and 24 weeks (primary endpoint)
Awards & highlights

Study Summary

This trial tests if HPV vaccine can treat warts that don't respond to other treatments.

Who is the study for?
This trial is for adults over 18 with stubborn skin warts that haven't gone away after treatments like freezing, acids, or injections. Participants must understand the study and agree to it in writing. People can't join if they have genital or oral warts, are very sick right now, have a weak immune system, are allergic to HPV vaccines, might get pregnant, or had wart treatment in the last month.Check my eligibility
What is being tested?
The study tests if the HPV vaccine can treat tough-to-remove skin warts compared to a placebo (a harmless saline solution). It's a double-blind trial where neither participants nor researchers know who gets the real vaccine or placebo until after results are collected.See study design
What are the potential side effects?
Possible side effects of the HPV vaccine may include pain at injection site, headache, fever, nausea and dizziness. Severe allergic reactions are rare but possible for those sensitive to ingredients in the vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with skin warts.
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I am 18 years old or older.
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I have tried treatments for skin warts before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~safety assessment will occur at 0, 4, 8, 20, and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and safety assessment will occur at 0, 4, 8, 20, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 24 weeks
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 4 weeks
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 8 weeks
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events
Skindex-16

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HPV VaccineExperimental Treatment1 Intervention
0.5-mL suspension of 9-valent Gardasil vaccine administered as intramuscular injection at weeks 0, 4, and 20
Group II: PlaceboPlacebo Group1 Intervention
0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human Papillomavirus 9-valent Vaccine, Recombinant
2017
Completed Phase 4
~20

Find a Location

Who is running the clinical trial?

Western Institute for Veterans ResearchLead Sponsor
1 Previous Clinical Trials
62 Total Patients Enrolled
University of UtahOTHER
1,099 Previous Clinical Trials
1,778,569 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,551 Total Patients Enrolled
4 Trials studying Warts
6,164 Patients Enrolled for Warts

Media Library

Human Papillomavirus 9-valent Vaccine, Recombinant (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05625633 — Phase 2 & 3
Warts Research Study Groups: Placebo, HPV Vaccine
Warts Clinical Trial 2023: Human Papillomavirus 9-valent Vaccine, Recombinant Highlights & Side Effects. Trial Name: NCT05625633 — Phase 2 & 3
Human Papillomavirus 9-valent Vaccine, Recombinant (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05625633 — Phase 2 & 3

Frequently Asked Questions

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

Are there any unfilled participant positions for this trial?

"Clinicaltrials.gov declares that this medical trial is not currently enrolling participants, as its last update was made on November 23rd 2022. However, there are presently 20 other studies which are actively recruiting candidates for study participation."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

What questions have other patients asked about this trial?

Has the vaccine been working so far has to been able to contain outbreaks possibly stop them?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts
2024. "Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05625633.
All > Hpv
~80 spots leftby Dec 2025
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