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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 is a Phase 1 study that has not yet begun recruiting, run by Ohio State University. The registered enrollment target is 50 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07339163
The ClinicalTrials.gov registry entry for NCT07339163 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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