Gardasil-9 Booster for Respiratory Papillomatosis
(*ISI *RRP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a booster shot of the Gardasil-9 vaccine can benefit adults with recurrent respiratory papillomatosis (RRP) who continue to face frequent issues despite previous vaccinations. RRP involves non-cancerous growths that repeatedly appear in the airways, caused by HPV (human papillomavirus). The researchers aim to determine if this booster can extend the interval between necessary surgeries. Suitable candidates have had RRP for a while, undergone at least two surgeries, and received the Gardasil-9 series over two years ago. As a Phase 1, Phase 2 trial, this research seeks to understand how the booster works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Studies have shown that the GARDASIL®9 vaccine, which protects against human papillomavirus (HPV), is safe. Over 15 years of research have confirmed its safety, with most side effects being minor. A ten-year review of reported cases found that side effects were generally mild. This vaccine has also successfully reduced the recurrence of respiratory papillomatosis, a condition where non-cancerous growths form in the airway.
Additionally, a long-term study found that the vaccine remains safe and effective even ten years after administration, continuing to protect without major safety concerns. The vaccine also improves health outcomes for patients with conditions like respiratory papillomatosis.
Overall, evidence shows that GARDASIL®9 is well-tolerated, making it a promising option for those considering participation in this booster vaccine study.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for respiratory papillomatosis, which often involve surgical interventions or antiviral medications, GARDASIL®9 is a vaccine that offers a preventative approach. Researchers are excited about this treatment because it works by boosting the immune response specifically against HPV types associated with the condition, potentially reducing the recurrence of papillomas. This vaccine-based strategy could significantly decrease the need for repeated surgeries and improve the quality of life for patients.
What evidence suggests that the Gardasil-9 booster could be an effective treatment for recurrent respiratory papillomatosis?
Research has shown that Gardasil-9 can reduce the number of surgeries needed for recurrent respiratory papillomatosis (RRP). In a study with 50 patients, the number of surgeries required decreased significantly after vaccination. Gardasil-9 provides long-lasting protection against HPV, the virus causing RRP, and extends the time between surgeries. Some evidence suggests the vaccine's effect might diminish over time, so this trial examines a booster dose for those who completed the initial vaccine series. Overall, Gardasil-9 has proven safe and effective in lessening RRP's impact on patients.15678
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
Citations
Outcomes After Human Papillomavirus Vaccination in ...
This nonrandomized clinical trial of 50 patients with RRP found a significant decline in postvaccination frequency of recurrences requiring surgical ...
Efficacy of Booster Injection With Gardasil-9 Vaccine on ...
Secondary objectives of this study are to further characterize the efficacy and safety of the Gardasil-9 booster in adults with recurrent ...
HPV Vaccine Safety and Effectiveness Data
More than 15 years of monitoring and research have accumulated reassuring evidence that HPV vaccination provides safe, effective, and long-lasting protection.
HPV vaccination improves immune response in children ...
The HPV vaccine is safe and effective in improving the overall health and quality of life of children with recurrent respiratory papillomatosis.
5.
catalogues.ema.europa.eu
catalogues.ema.europa.eu/system/files/2024-09/V503-088-01-v1-final-redaction.pdfV503-088-01-v1 final redaction - HMA-EMA Catalogues
study evaluating effectiveness of GARDASIL™/ GARDASILTM 9 against adult-onset recurrent respiratory papillomatosis (AoRRP) in Sweden, Denmark, ...
Adverse events following 9-valent human papillomavirus ...
This ten-year VAERS-based analysis reaffirms the overall safety profile of GARDASIL 9, with most reported adverse events being non-serious and ...
7.
publications.aap.org
publications.aap.org/pediatrics/article/152/4/e2022060993/193886/Ten-Year-Follow-up-of-9-Valent-HumanTen-Year Follow-up of 9-Valent Human Papillomavirus ...
These data demonstrate long-term immunogenicity, effectiveness, and safety of the 9vHPV vaccine, 10 years after its administration. These end-of ...
Outcomes After Human Papillomavirus Vaccination in ...
Significant declines in juvenile-onset recurrent respiratory papillomatosis following human papillomavirus (HPV) vaccine introduction in the ...
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