Intralesional HPV Vaccine for Condylomata

NCT ID: NCT05087849

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2024-07-01

Brief Summary

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

Detailed Description

This is a prospective, open-label, proof-of-concept research study to assess the effectiveness of intralesional nonavalent in the treatment of patients with genital condylomata. The study will be conducted at Zuckerberg San Francisco General Hospital. The planned intervention is to provide 10 subjects with at least 3 genital condylomata with intralesional nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for change in wart size and wart number.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intralesional injection of nonavalent human papillomavirus vaccine

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

Group Type: EXPERIMENTAL

nonavalent human papillomavirus vaccine

Intervention Type: BIOLOGICAL

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

Interventions

nonavalent human papillomavirus vaccine

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayan Kusari, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

21-35086

Identifier Type: -

Identifier Source: org_study_id