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

Phase 3

• Conditions: Recurrent Respiratory Papillomatosis
• Interventions: Biological: 4-valent HPV vaccine

• Registration Number: NCT01995721
• Lead Sponsor: National Institute of Child Health, Hungary

Brief 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.

Detailed 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 Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-20
• Study First Submitted QC: 2013-11-20
• Last Update Submitted: 2013-11-20
• Study First Posted: 2013-11-27
• Last Update Posted: 2013-11-27
• Study Start: 2014-02
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4-valent HPV vaccine	4-valent HPV vaccine	4-valent HPV vaccine administered in months 0., 2., 6.

Primary Outcome Measures

Name	Time	Method
Papilloma relapses	18 months after the 3rd vaccine	Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period

Trial Locations

Locations (1)

National Institute of Child Health; 🇭🇺 Budapest, Hungary