NCT07339163|Not Yet RecruitingPhase 1/2DMCFDA Drug
Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*
*ISI *RRP
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Sponsor study identifier
interventional
50
1 country
1
Study Start
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 4, 2026
Actual (reported)January 14, 2026
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Intersurgical Interval
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 to evaluate if administration of a booster dose of Gardasil-9 increases ISI. We will also calculate cohort-mean of ISI-1 to provide context and cohort ISI changes over time. Intersurgical Interval (ISI) - time, in days, between any two surgical interventions for treatment of a patient's disease ISI-1: ISI prior to the administration of the 2- or 3-dose Gardasil-9 course ISI-2: ISI before the booster Gardasil-9 dose, but after completion of the 2-or 3-dose course ISI-3: ISI post-booster
5 years
Safety and Adverse Events
The primary safety objective will characterize any adverse events and side effects that occur as a result of administration of the booster vaccine. Our primary safety hypothesis is that the administration of an additional booster vaccine of Gardasil-9 will not significantly increase the incidence of adverse events or side effects as compared to the side effect profile of the 2- or 3-dose vaccine series.
5 years
Efficacy and Safety
5 years
Administration of Gardasil-9 vaccine as booster dose following 3-dose vaccine series in patients with RRP.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Otolaryngology - Head & Neck Surgery
Columbus, Ohio, 43212, United States
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.
Laura Matrka, Doctor of Medicine
Ohio State University
First Submitted
January 4, 2026
First Posted
January 14, 2026
Study Start
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 1, 2028
Contact the study team to confirm eligibility.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2025-12
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