4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children

Study Overview
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Brief Summary
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Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process. After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.

Detailed Description
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Enrollment ear-nose-throat (ENT) examination + oesophagoscopy immunological assessment assessment of selected humoral (antibodies) and cellular immune response parameters(INF gamma and granzyme B testing) in vitro and in vivo stimulation of PMBCs with the HPV-4 vaccine Immunization with 4-valent HPV vaccine at 0,2,6 months Follow up 1 month after 3rd vaccine dose - immunological assessment (same tests as in the enrollment phase) 6, 12 and 18 months after the 3rd vaccine dose - ENT + oesophagoscopy

Official Title
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Phase III, Single-center Clinical Trial to Evaluate the 4-valent HPV Vaccine for the Treatment and Prevention of Recurrent Respiratory Papillomatosis in Children

Conditions
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Recurrent Respiratory Papillomatosis

Intervention / Treatment
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* Biological: 4-valent HPV vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: respiratory papillomatosis at least 3 relapses in patient history HPV 6 and/or 11 positive papillomas able to mount neutralizing antibodies Exclusion Criteria: other chronic underlying condition other HPV type no antibody response

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4-valent HPV vaccine<br>4-valent HPV vaccine administered in months 0., 2., 6. | Biological: 4-valent HPV vaccine<br>* Vaccination with 4-valent HPV vaccine in months 0., 2., 6.<br>* Other names: Gardasil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Papilloma relapses | Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period | 18 months after the 3rd vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent respiratory papillomatosis, human papillomavirus, vaccine, treatment, immunology, relapse