Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*
NCT ID: NCT07339163
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2026-04-01
2035-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Booster Administered
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
Administration of Gardasil-9 vaccine as booster dose following 3-dose vaccine series in patients with RRP.
Interventions
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GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
Administration of Gardasil-9 vaccine as booster dose following 3-dose vaccine series in patients with RRP.
Eligibility Criteria
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Inclusion Criteria
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
* 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)
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Ohio State University
OTHER
Responsible Party
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Laura Matrka
Professor of Clinical Otolaryngology
Principal Investigators
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Laura Matrka, Doctor of Medicine
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Department of Otolaryngology - Head & Neck Surgery
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Erickson EL, Freeman TE, Sun S, Koch B, Allen DZ, Sethia R, deSilva B, Matrka L. Recurrent respiratory papillomatosis disease course in immunosuppressed populations. J Laryngol Otol. 2024 May;138(5):576-580. doi: 10.1017/S0022215123001470. Epub 2023 Oct 25.
."Census Profile: Columbus, OH Metro Area." Census Reporter, censusreporter.org/profiles/31000US18140-columbus-oh-metro-area/. Accessed 1 July 2024. "Health Equity." The Ohio State University Wexner Medical Center, wexnermedical.osu.edu/health-equity. Accessed 1 July 2024.
Oshman LD, Davis AM. Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP). JAMA. 2020 Feb 4;323(5):468-469. doi: 10.1001/jama.2019.18411. No abstract available.
Buchinsky FJ, Ruszkay N, Valentino W, Derkay CS, McClay JE, Bastian RW, Myer CM, Lollar KW, Guris D. In RRP, serologic response to HPV is frequently absent and slow to develop. PLoS One. 2020 Mar 11;15(3):e0230106. doi: 10.1371/journal.pone.0230106. eCollection 2020.
Makiyama K, Hirai R, Matsuzaki H. Gardasil Vaccination for Recurrent Laryngeal Papillomatosis in Adult Men: First Report: Changes in HPV Antibody Titer. J Voice. 2017 Jan;31(1):104-106. doi: 10.1016/j.jvoice.2016.01.008. Epub 2016 Apr 8.
Tjon Pian Gi RE, San Giorgi MR, Pawlita M, Michel A, van Hemel BM, Schuuring EM, van den Heuvel ER, van der Laan BF, Dikkers FG. Immunological response to quadrivalent HPV vaccine in treatment of recurrent respiratory papillomatosis. Eur Arch Otorhinolaryngol. 2016 Oct;273(10):3231-6. doi: 10.1007/s00405-016-4085-3. Epub 2016 May 17.
Hocevar-Boltezar I, Maticic M, Sereg-Bahar M, Gale N, Poljak M, Kocjan B, Zargi M. Human papilloma virus vaccination in patients with an aggressive course of recurrent respiratory papillomatosis. Eur Arch Otorhinolaryngol. 2014 Dec;271(12):3255-62. doi: 10.1007/s00405-014-3143-y. Epub 2014 Jun 26.
Rosenberg T, Philipsen BB, Mehlum CS, Dyrvig AK, Wehberg S, Chirila M, Godballe C. Therapeutic Use of the Human Papillomavirus Vaccine on Recurrent Respiratory Papillomatosis: A Systematic Review and Meta-Analysis. J Infect Dis. 2019 Mar 15;219(7):1016-1025. doi: 10.1093/infdis/jiy616.
Ponduri A, Azmy MC, Axler E, Lin J, Schwartz R, Chirila M, Dikkers FG, Yang CJ, Mehta V, Gangar M. The Efficacy of Human Papillomavirus Vaccination as an Adjuvant Therapy in Recurrent Respiratory Papillomatosis. Laryngoscope. 2023 Sep;133(9):2046-2054. doi: 10.1002/lary.30560. Epub 2023 Jan 18.
Ivancic R, Freeman T, de Silva B, Forrest A, Kim B, Matrka L. Adjuvant Human Papillomavirus Vaccination in Recurrent Respiratory Papilloma Patients Older than 45. Laryngoscope. 2024 Jul;134(7):3226-3229. doi: 10.1002/lary.31368. Epub 2024 Feb 24.
Nyirjesy S, Osmundson P, Matrka L. Spontaneous Regression of Recurrent Respiratory Papillomatosis with HPV Vaccination: A Case Study. J Voice. 2022 Jul;36(4):587.e21-587.e25. doi: 10.1016/j.jvoice.2020.08.013. Epub 2020 Sep 3.
Ivancic R, Iqbal H, deSilva B, Pan Q, Matrka L. Current and future management of recurrent respiratory papillomatosis. Laryngoscope Investig Otolaryngol. 2018 Jan 14;3(1):22-34. doi: 10.1002/lio2.132. eCollection 2018 Feb.
Yiu Y, Fayson S, Smith H, Matrka L. Implementation of Routine HPV Vaccination in the Management of Recurrent Respiratory Papillomatosis. Ann Otol Rhinol Laryngol. 2019 Apr;128(4):309-315. doi: 10.1177/0003489418821695. Epub 2018 Dec 29.
Ballestas SA, Shelly S, Soriano RM, Klein A. Trends in recurrent respiratory papillomatosis treatment. Acta Otorrinolaringol Esp (Engl Ed). 2021 Mar-Apr;72(2):109-120. doi: 10.1016/j.otorri.2019.11.001. Epub 2020 Apr 17. English, Spanish.
Other Identifiers
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STUDY20251324
Identifier Type: -
Identifier Source: org_study_id
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