Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*

The investigators propose the study titled "Efficacy of booster injection with Gardasil-9 vaccine on intersurgical interval (ISI) for adults with recurrent respiratory papillomatosis (RRP)". Recurrent respiratory papillomatosis (RRP) is a human papilloma virus (HPV) mediated disease of recurrent benign papillomas within the aerodigestive tract. While the foundation of treatment remains surgical debulking and occasionally adjuvant therapies such as cidofovir and bevacizumab, there remains a population of patients suffering from aggressive disease recurrence despite treatment. Multiple studies have demonstrated treatment benefit in the form of an increase in intersurgical interval (ISI), following Gardasil vaccination. While adjuvant vaccination has favorably reduced recurrence of RRP and improved time course of disease recurrence for previously unvaccinated RRP patients, there remains a clinical population of adult patients suffering from persistent RRP that have previously undergone the Gardasil 3-vaccine series. Additionally, recent studies suggest a waning effect of Gardasil vaccination on ISI at longer time points. Therefore, the investigators propose administering GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) 0.5-mL suspension for injection as a one-time "booster" dose to adult patients \>18 years of age, who have previously completed the 3-course vaccination series.

NCT Number	NCT07339163
Lead Sponsor	Ohio State University Collaborators: Merck Sharp & Dohme LLC
Conditions	Recurrent Respiratory Papillomatosis (RRP)
Enrollment	50 participants
Start Date	2026-04-01
Primary Completion	2028-04-01 (estimated)
Study Completion	2035-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-22