Intralesional HPV Vaccine for Condylomata

NCT05087849 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 21-35086
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate whether injecting genital warts with small quantities of the Gardasil 9 vaccine has an effect on the warts.

Conditions

Human Papilloma Virus; Warts; Warts, Genital; Condyloma; Condylomata Acuminata

Keywords

Gardasil 9; nonavalent human papillomavirus vaccine; intralesional immunotherapy; condyloma; genital warts

Outcome Measures

Primary Outcomes (2)

• Change in Wart Number

  Change in number of warts in genital area.

  Baseline (week 0) and Week 12.

• Change in Average Size of Genital Warts in mm

  Mean size of warts in genital area, as measured by study personnel at study visits .

  to be measured at baseline (week 0) and Week 12

Secondary Outcomes (2)

• Change in Score of Specific Questionnaire for Condylomata Acuminata (CECA)

  to be measured at baseline (week 0) and week 12

• Change in Score of Dermatology Quality of Life Index (DLQI)

  to be measured at baseline (week 0) and week 12

Study Arms (1)

Intralesional injection of nonavalent human papillomavirus vaccine

EXPERIMENTAL

Single-arm, open-label study. Intervention consists of intralesional injection of nonavalent human papillomavirus vaccine at 0 and 4 weeks.

Biological: nonavalent human papillomavirus vaccine

Interventions

nonavalent human papillomavirus vaccine BIOLOGICAL

Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks

Intralesional injection of nonavalent human papillomavirus vaccine

Eligibility Criteria

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

You may qualify if:

• Patients of all genders aged ≥ 18 years
• Signed informed consent form
• Confirmed clinical diagnosis of genital condylomata with minimum of 3 genital condylomata, each measuring \>3mm
• Individuals who are able to become pregnant will be advised on the following:
• All individuals who are able to become pregnant will be asked about their reproductive health, sexual activity (partners, practices, prevention of pregnancy) and be advised that administration of vaccine during pregnancy is not recommended while data collection to monitor pregnancy and infant outcomes following exposure to the papillomavirus (9-valent) vaccine is ongoing. However, based on available data, an increased risk of adverse pregnancy outcomes, specifically miscarriage or congenital anomalies, has not been observed following inadvertent administration of the papillomavirus vaccine during pregnancy. Individuals who are able to become pregnant are advised to contact us immediately and will not receive any further intralesional vaccine.

You may not qualify if:

• Participants will be asked about pregnancy at time of recruitments. Individuals who are pregnant or are planning to become pregnant will not be permitted to participate in the study, as ACOG does not recommend Gardasil 9 during pregnancy. Participants will be encouraged not to participate in the study if they believe they may become pregnant during the study.
• Participants will be asked about allergic reaction to yeast and vaccine components at time of recruitment. Subjects with severe allergic reactions to baker's yeast (Saccharomyces cerevisiae, a vaccine component), or other vaccine components (ie polysorbate 80, Merck amorphous aluminum hydroxyphosphate sulfate) will not be permitted to participate in this study.
• Participants' vaccination history will be reviewed at time of recruitment. Patients who have previously received any prior human papillomavirus vaccine will not be permitted to participate in this study.
• Subjects' medical history and current medications will be reviewed at time of recruitment. Subjects taking immune suppressive medications (steroids such as prednisone or dexamethasone, immunosuppressive agents such as methotrexate, azathioprine, cyclosporine, immunomodulatory agents such as apremilast, or immunomodulatory biologic agents such as adalimumab, guselkumab or ustekinumab) will be excluded. Subjects with medical conditions that significantly alter the immune system, such as known HIV infection, leukemia or lymphoma will be excluded from this pilot study.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Warts; Condylomata Acuminata

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

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; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ayan Kusari
• Organization: UCSF

ayan.kusari@ucsf.edu

4153537800

Study Officials

• Ayan Kusari, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, single-arm study in which all participants will receive intralesional Gardasil 9 vaccine to their condyloma.

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 21, 2021
• Study Start: April 15, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 2, 2025
• Results First Posted: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)