Gardasil-9 Booster for Respiratory Papillomatosis
(*ISI *RRP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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, we 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.
Who Is on the Research Team?
Laura Matrka, Doctor of Medicine
Principal Investigator
Ohio State University
Are You a Good Fit for This Trial?
Adults over 18 with recurrent respiratory papillomatosis (RRP), who have finished the Gardasil-9 vaccine series more than 2 years ago and still experience disease recurrence. Participants must have had at least two interventions to measure the time between surgeries.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Booster Administration
Participants receive a one-time booster dose of Gardasil-9 vaccine
Follow-up
Participants are monitored for safety and effectiveness after booster administration
What Are the Treatments Tested in This Trial?
Interventions
- GARDASIL®9
Trial Overview
The trial is testing if a booster shot of GARDASIL®9 can increase the time between surgeries for adults with RRP by reducing disease recurrence. It's a one-time injection given to those who've previously completed the vaccination series.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
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