Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts

NCT07806617 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: ORA#: 25042701-IRB01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Clearance of the Target Wart After Intralesional Gardasil-9 Treatment

  Clinical response of the target wart will be assessed using standardized photographs obtained before and after treatment. Short and long diameters of the wart will be measured from digital photographs, and changes in lesion area will be evaluated. Clinical response will also be assessed using the Physician Global Assessment (PGA) scale, ranging from 0 (complete response) to 4 (poor response), based on percentage improvement.

  Baseline through 12-14 weeks

• Incidence and Severity of Treatment-Related Adverse Reactions

  Safety will be assessed by documenting adverse reactions following intralesional treatment. Adverse reactions will be classified as mild, moderate, or severe based on their impact on participants' daily functioning and the need for clinician intervention.

  From first treatment through 12-14 weeks

Secondary Outcomes (1)

• Change in Dermatology Life Quality Index (DLQI) Score

  Baseline through completion of treatment

Other Outcomes (1)

• Clinical Response of Non-Injected Warts

  Baseline through 12-14 weeks

Study Arms (2)

Intralesional Gardasil-9

EXPERIMENTAL

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.

Biological: 9-valent human papillomavirus vaccine

Intralesional Sterile Saline Placebo

PLACEBO COMPARATOR

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.

Other: Sterile Saline

Interventions

Sterile Saline OTHER

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

Also known as: placebo

Intralesional Sterile Saline Placebo

9-valent human papillomavirus vaccine BIOLOGICAL

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.

Also known as: Gardasil-9

Intralesional Gardasil-9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Immunocompetent (no history of organ transplantation, active malignancy requiring immunosuppressive therapy, or HIV (human immunodeficiency virus) positive status)
• At least one wart that has been refractory to treatment
• At least two treatment modalities failed, including but not limited to:
• cryotherapy, electrodesiccation, keratolytic agents, bleomycin, salicylic acid, excision.

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Rush University Department of Dermatology: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (23)

• Kumar, S., Singh, O., Brar, S. K. & Gill, S. K. (2021). Efficacy and safety of intralesional quadrivalent human papillomavirus vaccine as immunotherapy in management of recalcitrant genital warts in a tertiary health care center of North India. National Journal of Physiology, Pharmacy and Pharmacology, 11 (5), 540-543. doi:10.5455/njppp.2021.11.03083202115032021

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MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and clinicians administering the study intervention are blinded to treatment assignment. Study treatments are prepared separately by the study coordinator so that the administering clinician does not know whether Gardasil-9 or sterile saline is being administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency Program Director

Model Details: Participants are randomized to receive intralesional Gardasil-9 or sterile saline during the double-blind, placebo-controlled treatment period. Following completion of the blinded treatment period and disclosure of treatment assignment, eligible participants may receive intralesional Gardasil-9 during an open-label extension.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: September 2, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)