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

January 21, 2026 updated by: Laura Matrka, Ohio State University

Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval (ISI) for Adults With Recurrent Respiratory Papillomatosis (RRP)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Department of Otolaryngology - Head & Neck Surgery
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura Matrka, Doctor of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age > 18 years old
  2. Has completed the 2- or 3-course Gardasil-9 vaccine series >2 years ago
  3. Has a diagnosis of recurrent respiratory papillomatosis
  4. Continue to have disease recurrence
  5. Have at least 2 interventions (in order to calculate ISI)

Exclusion Criteria:

  • Those who have not had at least two interventions prior to booster administration (inability to calculate ISI prior to 2- or 3-dose Gardasil-9 vaccine series and after completion of the vaccine series)
  • Patients who have had no interventions for their disease since vaccination (unable to calculate post-Gardasil 2- or 3-dose vaccine series ISI)
  • Have not completed the Gardasil-9 2- or 3-dose vaccine series greater than 2 years prior to proposed booster (not enough follow-up time to assess disease severity since vaccination)
  • Patients with active any HPV-related cancer - their treatment course may impact the data collected during the study duration
  • Any individual who has experienced anaphylaxis or hypersensitivity to a previous Gardasil vaccine (participation in this study would not be safe for the patient)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Booster Administered
Biological: GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
Administration of Gardasil-9 vaccine as booster dose following 3-dose vaccine series in patients with RRP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intersurgical Interval
Time Frame: 5 years

The primary objective of this study is to compare the cohort-mean ISI-3 (post and the cohort-mean ISI-2 to assess whether ISI lengthens following booster administration. Our primary hypothesis is that administration of an additional booster shot of the Gardasil-9 vaccine in patients who have previously completed the 2- or 3-dose vaccine series will result in an increased ISI-3 as compared to ISI-2.

The primary efficacy objective is to compare the cohort-mean of ISI-3 to the cohort-mean of ISI-2 to evaluate if administration of a booster dose of Gardasil-9 increases ISI. We will also calculate cohort-mean of ISI-1 to provide context and cohort ISI changes over time.

Intersurgical Interval (ISI) - time, in days, between any two surgical interventions for treatment of a patient's disease ISI-1: ISI prior to the administration of the 2- or 3-dose Gardasil-9 course ISI-2: ISI before the booster Gardasil-9 dose, but after completion of the 2-or 3-dose course ISI-3: ISI post-booster
5 years
Safety and Adverse Events
Time Frame: 5 years
The primary safety objective will characterize any adverse events and side effects that occur as a result of administration of the booster vaccine. Our primary safety hypothesis is that the administration of an additional booster vaccine of Gardasil-9 will not significantly increase the incidence of adverse events or side effects as compared to the side effect profile of the 2- or 3-dose vaccine series.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy and Safety
Time Frame: 5 years
Secondary objectives of this study are to further characterize the efficacy and safety of the Gardasil-9 booster in adults with recurrent respiratory papillomatosis (RRP) who have previously completed a 2- or 3-dose vaccine series. Specifically, we aim to evaluate the durability of ISI changes over time, assess subgroup differences (by age, sex, vaccination history, comorbidities, and baseline disease severity), and explore correlations between ISI improvement and key clinical outcomes such as recurrence rate and procedure frequency.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Laura Matrka, Doctor of Medicine, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2035

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20251324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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