Immunotherapy for Respiratory Papillomatosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called an autologous dendritic cell vaccine for individuals with recurrent respiratory papillomatosis (RRP), a condition caused by HPV6 that results in airway growths. The trial aims to assess the vaccine's safety and its ability to enhance the immune system. Participants must have a confirmed diagnosis of RRP with growths in the voice box and must have experienced these growths at least once in the past 6-12 months. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that vaccines made from a person's own cells have been tested for safety in treating recurrent respiratory papillomatosis, a condition affecting the airways. In these studies, researchers examined potential side effects, such as systemic symptoms, irritation, and swelling. Results so far suggest that the vaccine is generally safe for patients. However, specific numbers or detailed results from these studies are not available. As this trial is in an early stage, its primary goal is to assess the vaccine's safety for people.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for Recurrent Respiratory Papillomatosis (RRP) such as surgery and antiviral medication, the Autologous Dendritic Cell Vaccine offers a novel approach. This vaccine is personalized, made from a patient’s own cells, and aims to harness the immune system to target the human papillomavirus (HPV) responsible for RRP. Researchers are excited because this treatment could potentially reduce the need for repetitive surgeries and provide a more sustainable solution by addressing the root cause of the disease.
What evidence suggests that this treatment might be an effective treatment for respiratory papillomatosis?
Research shows that the autologous dendritic cell vaccine, administered to participants in this trial, might be promising for treating recurrent respiratory papillomatosis (RRP). This vaccine uses special immune cells from the patient's own body to combat the disease. Studies have found that vaccines targeting the human papillomavirus (HPV), which causes RRP, can reduce the frequency of disease recurrence. Specifically, patients have required fewer surgeries. This suggests the vaccine could help manage the condition by strengthening the body's natural defenses against the virus.12678
Who Is on the Research Team?
David G Lott, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for individuals with recurrent respiratory papillomatosis (RRP), specifically those with HPV6+ RRP in the larynx. Participants must have had recent papilloma presence or recurrence, be able to consent, and commit to follow-up visits and sample provision. Excluded are those with severe diseases, compromised immunity, active cancers other than RRP, heart issues, steroid use, pregnancy/breastfeeding intentions, or autoimmune diagnoses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive autologous dendritic cell vaccine to evaluate safety and immunogenicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Dendritic Cell Vaccine
Trial Overview
The study tests the safety and immune response of an autologous dendritic cell vaccine on patients with RRP. This personalized immunotherapy aims to stimulate the patient's own immune system to fight the virus causing papillomas in the throat.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients with clinically confirmed human papilloma virus (HPV)6+ Recurrent Respiratory Papillomatosis (RRP) in the laryngeal mucosa at the time of recruitment and patients with records of RRP in laryngeal mucosa at least once in the past 6-12 months at the time of recruitment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Autologous Dendritic Cell Vaccine For Recurrent ...
To measure time to disease recurrence of patients treated with autologous immunotherapy, we will measure the number of laryngeal papilloma during the treatment.
2.
ctv.veeva.com
ctv.veeva.com/study/autologous-dendritic-cell-vaccine-for-recurrent-respiratory-papillomatosis-rrp-patientsAutologous Dendritic Cell Vaccine For Recurrent Respiratory ...
The purpose of this study is to evaluate the safety and immunogenicity of autologous DC vaccine in recurrent respiratory papillomatosis ...
Recurrent Respiratory Papillomatosis (RRP)—Meta-analyses ...
Our meta-analyses concludes that HPV vaccine is a beneficial adjunct therapy alongside surgery. Subject terms: Tumour virus infections, Viral infection
4.
thelancet.com
thelancet.com/cms/10.1016/S2213-2600(24)00368-0/attachment/7f325b77-512a-41b7-ac70-20e5b80fe613/mmc1.pdfSupplementary appendix
PRGN-2012 gene therapy in adults with recurrent respiratory papillomatosis: a pivotal phase 1/2 clinical trial. Lancet Respir Med 2025; ...
Outcomes After Human Papillomavirus Vaccination in ...
In patients with recurrent RRP, decreased frequency of recurrences requiring surgical treatment was present after vaccination (from 0.85 to 0.36 ...
Autologous Dendritic Cell Vaccine For Recurrent ...
Safety will be assessed as number of participants to experience adverse events, including systemic symptoms, irritation, inflammation, and any adverse events ...
Preclinical study of a novel therapeutic vaccine for recurrent ...
The safety and efficacy of a novel gorilla adenovirus vaccine expressing a protein designed to elicit immune responses directed against HPV6 ...
8.
htsyndication.com
htsyndication.com/us-fed-news/article/clinical-trial%3A-autologous-dendritic-cell-vaccine-for-recurrent-respiratory-papillomatosis--rrp--patients/555787373Clinical Trial: Autologous Dendritic Cell Vaccine For ...
01, 2025. Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of autologous DC vaccine in recurrent ...
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