HPV Vaccine for Warts

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Warts
Human Papillomavirus 9-valent Vaccine, Recombinant - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This double-blinded clinical trial randomly assigns participants with refractory cutaneous warts to receive either treatment with the human papillomavirus (HPV) vaccine or a placebo to assess the efficacy of HPV vaccination for the treatment of refractory cutaneous warts.

Treatment Effectiveness

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Quality of life assessments will occur at 0 (baseline), 4, 8, and 24 weeks (primary endpoint)

Week 24
Skindex-16
Week 24
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
Week 4
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
Week 8
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
Week 24
Incidence of Treatment-Emergent Adverse Events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

HPV Vaccine
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

120 Total Participants · 2 Treatment Groups

Primary Treatment: HPV Vaccine · Has Placebo Group · Phase 2 & 3

HPV Vaccine
Biological
Experimental Group · 1 Intervention: Human Papillomavirus 9-valent Vaccine, Recombinant · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Normal Saline · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human Papillomavirus 9-valent Vaccine, Recombinant
2017
Completed Phase 4
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: quality of life assessments will occur at 0 (baseline), 4, 8, and 24 weeks (primary endpoint)

Who is running the clinical trial?

Western Institute for Veterans ResearchLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
University of UtahOTHER
992 Previous Clinical Trials
1,769,316 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,658 Previous Clinical Trials
4,955,022 Total Patients Enrolled
4 Trials studying Warts
6,164 Patients Enrolled for Warts
Lowell Nicholson, MDPrincipal InvestigatorUniversity of Utah Health Care System

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a clinical diagnosis of cutaneous warts.
You have received prior treatment for cutaneous warts.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: November 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.