A Randomized, Double-Blind, Placebo-Controlled Trial of Intralesional Gardasil-9 Vaccine for the Treatment of Recalcitrant Verrucae
Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study will evaluate whether Gardasil-9, a vaccine normally used to prevent human papillomavirus (HPV) infection, may be effective for treating recurring warts that have not responded to standard treatments. In this study, Gardasil-9 will be injected directly into a wart rather than into a muscle, which is an investigational use of the vaccine. Participants will be randomly assigned to receive injections of either Gardasil-9 or sterile saline (placebo) directly into a wart. Neither the participant nor the clinician administering the injection will know which treatment is being given. The study will evaluate participants during treatment and follow-up visits to assess their warts and quality of life.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Age 18 years or older.
• Immunocompetent (no history of organ transplantation, active malignancy requiring immunosuppressive therapy, or HIV positive status)
• At least one wart that has been refractory to treatment
• At least two treatment modalities failed, including but not limited to:
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.