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NCT Number: NCT07339163

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.

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Key information

Conditions

Recurrent Respiratory Papillomatosis (RRP) Recurrent respiratory papillomatosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Otolaryngology - Head & Neck Surgery

Columbus, Ohio, 43212, United States

Location contact

Emma T. Hill, Master degree

CONTACT

[email protected]

Laura A. Matrka, Doctor of Medicine

CONTACT

[email protected]

614-366-3687

Laura Matrka, Doctor of Medicine

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years old
  • Has completed the 2- or 3-course Gardasil-9 vaccine series >2 years ago
  • Has a diagnosis of recurrent respiratory papillomatosis
  • Continue to have disease recurrence
  • 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)

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Hill, Master degree

CONTACT

[email protected]

614-685-0847

Laura Matrka, Doctor of Medicine

CONTACT

[email protected]

614-366-3687

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: *ISI *RRP

Important dates

Study start
2026
Primary completion
2028
Study completion
2035
First posted
Jan 14, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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