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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01995721
• Other study ID #: 50934
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 20, 2013
• Last updated: November 20, 2013
• Start date: February 2014
• Est. completion date: February 2017

Study information

• Verified date: November 2013
• Source: National Institute of Child Health, Hungary
• Contact: Zsofia Meszner, MD, PhD
• Phone: +36 1 365 1540
• Email: zmeszner[@]gmail.com
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Papilloma
• Papillomavirus Infections
• Recurrent Respiratory Papillomatosis
• Respiratory Tract Infections

Intervention

Biological:
• 4-valent HPV vaccine
Vaccination with 4-valent HPV vaccine in months 0., 2., 6.

Locations

Country	Name	City	State
Hungary	National Institute of Child Health	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Child Health, Hungary	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No