Gardasil-9 for Warts
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Gardasil-9, a vaccine typically used to prevent HPV, can treat recurring warts unresponsive to standard treatments. Participants will receive injections directly into their warts, using either Gardasil-9 or a placebo (a harmless solution with no active ingredients). The goal is to determine if the vaccine can reduce or eliminate the warts and improve quality of life. Individuals who have had at least one wart resist treatment and have tried at least two different treatments without success may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from an innovative approach.
Is there any evidence suggesting that Gardasil-9 is likely to be safe for treating warts?
Research shows that Gardasil-9, a vaccine used to prevent HPV (human papillomavirus) infections, is generally safe. Studies have found that most people tolerate it well, with side effects usually mild or moderate. These side effects often include pain, swelling, and redness at the injection site. In rare cases, some individuals might faint or experience an allergic reaction, but these occurrences are uncommon.
Gardasil-9 is widely used to prevent certain types of HPV-related cancers, supported by strong safety data. Although this study involves injecting the vaccine directly into warts, the vaccine's established safety record offers reassurance.12345Why do researchers think this study treatment might be promising?
Researchers are excited about using Gardasil-9 for treating warts because it offers a unique approach compared to existing treatments like topical solutions, cryotherapy, or laser therapy. Unlike these standard methods, which often remove warts physically or chemically, Gardasil-9 targets the virus directly by using the 9-valent human papillomavirus (HPV) vaccine. This intralesional injection method aims to boost the body's immune response to clear the virus, potentially leading to more lasting results. Additionally, this treatment could simplify the process, requiring fewer visits and offering an innovative solution for stubborn warts.
What evidence suggests that Gardasil-9 might be an effective treatment for warts?
Research has shown that Gardasil-9, a vaccine, is highly effective against certain types of human papillomavirus (HPV). It can prevent infections and diseases related to HPV types 6, 11, 16, and 18 with up to 97% effectiveness. Early studies suggested it might also help reduce the recurrence of warts. While Gardasil-9 is typically used to prevent HPV-related cancers and genital warts, its direct application on warts is still under investigation. In this trial, participants may receive Gardasil-9 via intralesional injection into the selected wart or warts. The vaccine has demonstrated long-term effectiveness, but more research is needed to determine its efficacy in treating existing warts.26789
Are You a Good Fit for This Trial?
This trial is for people with warts, including plantar and periungual warts, that have not improved after standard treatments. Participants must be able to receive injections directly into their wart.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intralesional injections of Gardasil-9 or sterile saline into selected warts. Up to three warts may be treated per visit.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Photographs are taken to document wart resolution.
Open-label extension
Participants who received sterile saline may opt to receive Gardasil-9. Those initially on Gardasil-9 may continue treatment if warts have not resolved.
What Are the Treatments Tested in This Trial?
Interventions
- 9-valent human papillomavirus vaccine
Trial Overview
The study tests if injecting Gardasil-9 vaccine directly into stubborn warts helps clear them up compared to a placebo (sterile saline). Participants are randomly assigned to one of the two groups, and neither they nor their doctor knows which treatment they're getting.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants randomized to this arm will receive 9-valent human papillomavirus (HPV) vaccine (Gardasil-9) administered by intralesional injection into the selected wart or warts. Up to three warts may be treated during a treatment visit. Participants will return approximately every 4-6 weeks for evaluation and may receive additional treatment if the treated wart or warts have not resolved.
Participants randomized to this arm will receive sterile saline administered by intralesional injection as the placebo comparator. Participants will return approximately every 4-6 weeks for evaluation and may receive additional blinded treatment if the treated wart or warts have not resolved. After completion of the blinded study period and disclosure of treatment assignment, participants who received sterile saline will have the option to receive intralesional Gardasil-9 during the open-label extension.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
Rush University Department of Dermatology
Collaborator
Citations
Impact and Effectiveness of the Quadrivalent Human ... - PMC
Rapid reductions up to approximately 90% in HPV 6/11/16/18 infections and genital warts after introduction of 4vHPV vaccination programs were first demonstrated ...
HPV Vaccine Safety and Effectiveness Data
Studies in the United States and other countries have shown that HPV vaccination is already preventing cancer-causing infections, anogenital warts, and cervical ...
Efficacy of GARDASIL®9 (Human Papillomavirus 9-valent ...
Efficacy of GARDASIL 9 against certain cancers caused by HPV Types 31, 33, 45, 52, and 58. ~97% Effectiveness of GARDASIL 9 against HPV Types 6, 11, 16, 18, 31 ...
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine ...
GARDASIL 9 helps protect individuals ages 9 to 45 against the following diseases caused by 9 types of HPV: cervical, vaginal, and vulvar cancers in females, ...
5.
publications.aap.org
publications.aap.org/pediatrics/article/152/4/e2022060993/193886/Ten-Year-Follow-up-of-9-Valent-HumanTen-Year Follow-up of 9-Valent Human Papillomavirus ...
The 9vHPV vaccine demonstrated sustained immunogenicity and effectiveness through ∼10 years post 3 doses of 9vHPV vaccination of boys and girls ...
Human Papillomavirus (HPV) Vaccine Safety
A closer look at the safety data · HPV vaccines are safe · Gardasil 9, Gardasil and Cervarix · Fainting and anaphylaxis · Guillain-Barré syndrome (GBS) · Postural ...
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine ...
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast,
Use of 9-Valent Human Papillomavirus (HPV) Vaccine - PMC
The vaccine was well-tolerated, and most adverse events were injection site-related pain, swelling, and erythema that were mild to moderate in intensity.
Merck to Present New Data Reinforcing Long-Term ...
Data show long-term effectiveness of GARDASIL®9 and GARDASIL® 14 years and 18 years, respectively, following vaccination with 3 doses.
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