Recurrent Respiratory Papillomatosis (RRP)Phase 1/2*ISI *RRPNCT07339163
Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*
A Phase 1/2 study testing GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in people with Recurrent Respiratory Papillomatosis (RRP), run by Ohio State University at 1 site in United States.
Trial 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)". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Respiratory Papillomatosis (RRP)
- What is being tested?
- GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Apr 2035
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Department of Otolaryngology - Head & Neck Surgery
Columbus, Ohio, 43212
Laura A. Matrka, Doctor of Medicine, 614-366-3687, Laura.Matrka@osumc.edu
Emma T. Hill, Master degree, emma.hill@osumc.edu
About this study
Official title: Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval (ISI) for Adults With Recurrent Respiratory Papillomatosis (RRP)
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.
Read more
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.
- Being tested
- GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
- Keywords
- Recurrent Respiratory Papillomatosis (RRP), Human Papilloma Virus (HPV), Gardasil, Gardasil-9, Intersurgical Interval (ISI)
- Medical subject headings
- Recurrent respiratory papillomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)Biological
Administration of Gardasil-9 vaccine as booster dose following 3-dose vaccine series in patients with RRP.
| Study group | Role | What they receive |
|---|---|---|
| Booster Administered | Experimental | Not described Receives: Biological: GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 5 years
Secondary outcomes (1)
Efficacy and Safety
Secondary objectives of this study are to further characterize the efficacy and safety of the Gardasil-9 booster in adults with recurrent respiratory papillomatosis (RRP) who have previously completed a 2- or 3-dose vaccine series. Specifically, we aim to evaluate the durability of ISI changes over time, assess subgroup differences (by age, sex, vaccination history, comorbidities, and baseline disease severity), and explore correlations between ISI improvement and key clinical outcomes such as recurrence rate and procedure frequency.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Recurrent Respiratory Papillomatosis (RRP)Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Laura Matrka, Ohio State University
- Investigators
- Laura Matrka, Doctor of Medicine, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339163
- Sponsor's protocol ID
- STUDY20251324
- Acronym
- *ISI *RRP
- Status last verified
- Dec 2025
- First submitted
- 4 Jan 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 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.
PubMed 31930397Buchinsky 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.
PubMed 32160246Makiyama 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.
PubMed 27068425Tjon 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.
PubMed 27188508Hocevar-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.
PubMed 24964770Rosenberg 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.
PubMed 30358875Ponduri 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.
PubMed 36651338Ivancic 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.
PubMed 38401115Nyirjesy 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.
PubMed 32891477Ivancic 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.
PubMed 29492465Yiu 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.
PubMed 30595025Ballestas 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.
PubMed 32312478