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Cancer Vaccine
HPV Vaccine for Genital Warts
Phase 1 & 2
Recruiting
Led By Ayan Kusari, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed clinical diagnosis of genital condylomata with minimum of 3 genital condylomata, each measuring >3mm
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up to be measured at baseline (week 0) and week 12
Awards & highlights
Study Summary
This trial will test whether the HPV vaccine Gardasil 9 can help treat genital warts.
Who is the study for?
This trial is for adults over 18 with genital warts, specifically at least three warts larger than 3mm. Participants must not be on immune-suppressing drugs or have conditions affecting their immune system, and they can't be pregnant or planning to become pregnant soon. They also shouldn't have had an HPV vaccine before or be allergic to yeast and vaccine components.Check my eligibility
What is being tested?
The study is testing the effects of injecting small amounts of Gardasil 9, a nonavalent human papillomavirus vaccine, directly into genital warts to see if it helps treat them.See study design
What are the potential side effects?
While specific side effects are not listed here, typical reactions may include pain at the injection site, swelling, redness, headaches, fever and nausea. Serious allergic reactions could occur in those with sensitivities to yeast or other vaccine ingredients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with genital warts, with at least 3 warts each bigger than 3mm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ to be measured at baseline (week 0) and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to be measured at baseline (week 0) and week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Genitalia
Change in mean size of genital condyloma between Week 0 (baseline) and Week 4
Change in wart number between Week 0 (baseline) and Week 12
+1 moreSecondary outcome measures
Change in score of Dermatology quality of life index (DLQI)
Change in score of Specific Questionnaire for Condylomata Acuminata (CECA)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intralesional injection of nonavalent human papillomavirus vaccineExperimental Treatment1 Intervention
Single-arm, open-label study. Intervention consists of intralesional injection of nonavalent human papillomavirus vaccine at 0 and 4 weeks.
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,545 Total Patients Enrolled
Ayan Kusari, MDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will follow guidance on preventing pregnancy during the trial.Women who can get pregnant will be asked about their reproductive health and advised not to get pregnant while participating in the study. If they think they might be pregnant, they should contact the study team right away and will no longer receive the vaccine.I have been diagnosed with genital warts, with at least 3 warts each bigger than 3mm.I am not on immune suppressive medications nor do I have conditions affecting my immune system.You are allergic to yeast or any parts of the vaccine.I am 18 years old or older.I have received an HPV vaccine in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Intralesional injection of nonavalent human papillomavirus vaccine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we currently recruiting participants for this research?
"This study, which was posted on clinicaltrials.gov on 4/15/2022 and last updated on 5/20/2022, is currently looking for participants."
Answered by AI
How many people are signed up to participate in this research project?
"The latest information from clinicaltrials.gov indicates that this trial is still recruiting patients. This research was first made public on April 15th, 2022 and the 5/20/2022 update suggests that 1 site is looking for 10 total participants."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Zuckerberg San Francisco General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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