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

Recurrent Respiratory Papillomatosis Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

1. 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

2. Immunization with 4-valent HPV vaccine at 0,2,6 months

3. 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 ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01995721
Study type Interventional
Source National Institute of Child Health, Hungary
Contact Zsofia Meszner, MD, PhD
Phone +36 1 365 1540
Email zmeszner@gmail.com
Status Not yet recruiting
Phase Phase 3
Start date February 2014
Completion date February 2017
View Details
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