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NCT07339163 · ClinicalTrials.gov registry record · Phase 1
Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*
A Phase 1 study, sponsored by Ohio State University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT07339163: Clinical Trial Phase 1 study, sponsored by Ohio State University.
NCT07339163 is a Phase 1 study that has not yet begun recruiting, run by Ohio State University. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07339163, a Phase 1 study, has not yet begun recruiting, sponsored by Ohio State University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- BIOLOGICAL GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2035-04-01 |
| Phase | Phase 1 |
What is known before NCT07339163 opens enrollment
NCT07339163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is the first listed.
NCT07339163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07339163 about?
NCT07339163 is a clinical study titled "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 be...
What is the current status of trial NCT07339163?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2026-04-01. Estimated completion is 2035-04-01.
What interventions are being tested in trial NCT07339163?
The interventions under investigation include: GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) (BIOLOGICAL).
Who is sponsoring clinical trial NCT07339163?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07339163's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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