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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01995721
First Posted: November 27, 2013
Last Update Posted: November 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary
  Purpose

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.


Condition Intervention Phase
Recurrent Respiratory Papillomatosis Biological: 4-valent HPV vaccine Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Silgard
  • Gardasil

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995721


Contacts
Contact: Zsofia Meszner, MD, PhD +36 1 365 1540 zmeszner@gmail.com

Locations
Hungary
National Institute of Child Health Not yet recruiting
Budapest, Hungary, 1113
Contact: Zsofia Meszner    +36 1 365-1540    zmeszner@gmail.com   
Principal Investigator: Zsofia Meszner, MD, PhD         
Sponsors and Collaborators
National Institute of Child Health, Hungary
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Zsofia Meszner, MD, PhD National Institute of Child Health
  More Information

Responsible Party: dr. med habil Zsófia Meszner PhD, Professor, National Institute of Child Health, Hungary
ClinicalTrials.gov Identifier: NCT01995721     History of Changes
Other Study ID Numbers: 50934
First Submitted: November 20, 2013
First Posted: November 27, 2013
Last Update Posted: November 27, 2013
Last Verified: November 2013

Keywords provided by dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary:
recurrent respiratory papillomatosis
human papillomavirus
vaccine
treatment
immunology
relapse

Additional relevant MeSH terms:
Papilloma
Respiratory Tract Infections
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Infection
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs