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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07339163
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Recurrent Respiratory Papillomatosis (RRP)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) — BIOLOGICAL
    Administration of Gardasil-9 vaccine as booster dose following 3-dose vaccine series in patients with RRP.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Dec 2025
Primary completion
Apr 1, 2028
Completion
Apr 1, 2035

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Booster Administered

Primary Outcome Measure

Intersurgical Interval [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Otolaryngology - Head & Neck SurgeryColumbusOhio43212
Laura A. Matrka, Doctor of Medicine
[email protected]
614-366-3687
Emma T. Hill, Master degree
[email protected]
Laura Matrka, Doctor of Medicine (PRINCIPAL_INVESTIGATOR)

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By research site
Department of Otolaryngology - Head & Neck Surgery· Columbus, OH