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

November 20, 2013 updated by: dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1113
        • National Institute of Child Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 4-valent HPV vaccine
4-valent HPV vaccine administered in months 0., 2., 6.
Biological: 4-valent HPV vaccine
Vaccination with 4-valent HPV vaccine in months 0., 2., 6.
Other Names:
  • Gardasil
  • Silgard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Papilloma relapses
Time Frame: 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
18 months after the 3rd vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Child Health, Hungary

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Zsofia Meszner, MD, PhD, National Institute of Child Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

February 1, 2017

Study Completion (ANTICIPATED)

February 1, 2017

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (ESTIMATE)

November 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 20, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50934

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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