search
Back to results

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

Primary Purpose

Recurrent Respiratory Papillomatosis

Status
Unknown status
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
4-valent HPV vaccine
Sponsored by
National Institute of Child Health, Hungary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Respiratory Papillomatosis focused on measuring recurrent respiratory papillomatosis, human papillomavirus, vaccine, treatment, immunology, relapse

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Child Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

4-valent HPV vaccine

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 20, 2013
Last Updated
November 20, 2013
Sponsor
National Institute of Child Health, Hungary
Collaborators
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01995721
Brief Title
4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Child Health, Hungary
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Respiratory Papillomatosis
Keywords
recurrent respiratory papillomatosis, human papillomavirus, vaccine, treatment, immunology, relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4-valent HPV vaccine
Arm Type
Experimental
Arm Description
4-valent HPV vaccine administered in months 0., 2., 6.
Intervention Type
Biological
Intervention Name(s)
4-valent HPV vaccine
Other Intervention Name(s)
Silgard, Gardasil
Intervention Description
Vaccination with 4-valent HPV vaccine in months 0., 2., 6.
Primary Outcome Measure Information:
Title
Papilloma relapses
Description
Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period
Time Frame
18 months after the 3rd vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zsofia Meszner, MD, PhD
Phone
+36 1 365 1540
Email
zmeszner@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zsofia Meszner, MD, PhD
Organizational Affiliation
National Institute of Child Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Child Health
City
Budapest
ZIP/Postal Code
1113
Country
Hungary
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsofia Meszner
Phone
+36 1 365-1540
Email
zmeszner@gmail.com
First Name & Middle Initial & Last Name & Degree
Zsofia Meszner, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs