NCT05087849

Intralesional HPV Vaccine for Condylomata

Therapeutic Intralesional Nonavalent HPV Vaccine for Genital Condylomata in Adults: an Open Label Pilot Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2022-04-15
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2021-10-21
• Last updated: 2025-10-02
• Results posted: 2025-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study