Booster shot may extend time between surgeries for RRP patients
NCT ID NCT07339163
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a one-time booster dose of the Gardasil-9 vaccine can lengthen the time between surgeries for adults with recurrent respiratory papillomatosis (RRP), a condition where non-cancerous growths keep coming back in the airway. Researchers will enroll 50 adults who have already received the full Gardasil-9 series but still need repeat surgeries. The goal is to see if the booster reduces how often surgery is needed, without causing new side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Otolaryngology - Head & Neck Surgery
Columbus, Ohio, 43212, United States