Recruiting
Phase 2

Gardasil-9

Sponsor:

Rush University Medical Center

Code:

NCT07806617

Conditions

Warts

Verruca (Warts)

Verruca Vulgaris

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

9-valent human papillomavirus vaccine

Sterile Saline

Study Details

Brief 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.

Conditions

Warts

Verruca (Warts)

Verruca Vulgaris

Study ID

NCT07806617

Start date

Sep 2, 2025

Status verified date

Sep, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

cryotherapy, electrodessication, keratolytic agents, bleomycin, salicylic acid, excision.

Exclusion Criteria:

  • Unable to provide informed consent.
  • Younger than 18 years of age.
  • Pregnant.
  • Prisoner.
  • Vulnerable populations, including immunocompromised status (active cancer, active TB - latent or previous history of these would not exclude patients)
  • Previous severe reaction to HPV vaccination or known allergy to any vaccine component.

Study Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intralesional Gardasil-9

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.

placebo comparator: Intralesional Sterile Saline Placebo

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.

Interventions

9-valent human papillomavirus vaccine

9-valent human papillomavirus (HPV) vaccine administered by intralesional injection directly into the selected wart or warts. Up to three warts may be treated during a treatment visit. Participants may receive additional treatments at approximately 4-6 week intervals if the treated wart or warts have not resolved. Participants may elect to receive lidocaine for local anesthesia prior to administration of the study intervention.

Sterile Saline

Sterile saline administered by intralesional injection as the placebo comparator during the double-blind treatment period.

Primary outcome measure

  • Clearance of the Target Wart After Intralesional Gardasil-9 Treatment [ Time Frame: Baseline through 12-14 weeks ]
  • Incidence and Severity of Treatment-Related Adverse Reactions [ Time Frame: From first treatment through 12-14 weeks ]

Central Contacts and Locations

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

David C Reid, MD

(312) 942-2195David_c_reid@rush.edu

Principal Investigator:

David C Reid, MD

More Information

Sponsor

Rush University Medical Center

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Recalcitrant Warts
  • Recalcitrant Verrucae
  • Verruca Vulgaris
  • Human Papillomavirus
  • Gardasil-9
  • Intralesional Immunotherapy
  • Intralesional HPV Vaccine
  • HPV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-09-08.