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

Официальное название

Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval (ISI) for Adults With Recurrent Respiratory Papillomatosis (RRP)

Обзор

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.

Вмешательства

• Биопрепарат 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.

Первичные конечные точки

• Intersurgical Interval [Срок оценки: 5 years]
• Safety and Adverse Events [Срок оценки: 5 years]

Вторичные конечные точки (1)

• Efficacy and Safety [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age > 18 years old
• Has completed the 2- or 3-course Gardasil-9 vaccine series >2 years ago
• Has a diagnosis of recurrent respiratory papillomatosis
• Continue to have disease recurrence
• Have at least 2 interventions (in order to calculate ISI)

Критерии исключения

• Those who have not had at least two interventions prior to booster administration (inability to calculate ISI prior to 2- or 3-dose Gardasil-9 vaccine series and after completion of the vaccine series)
• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Department of Otolaryngology - Head & Neck Surgery — Columbus

Публикации

• 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. PMID 37877153
• ."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. PMID 31930397
• 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. PMID 32160246
• 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. PMID 27068425
• 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. PMID 27188508
• 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. PMID 24964770
• 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. PMID 30358875

Идентификаторы

NCT: NCT07339163 · STUDY20251324

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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