Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*

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.

Timeline

Start

2026-04-01

Primary completion

2028-04-01

Completion

2035-04-01

Publications

• Background 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.
• Background ."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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.

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