ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01995721
Recruitment Status : Unknown
Verified November 2013 by dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary.
Recruitment status was:  Not yet recruiting
First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Recurrent Respiratory Papillomatosis Biological: 4-valent HPV vaccine Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : February 2014
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
  • Silgard
  • Gardasil


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: November 27, 2013    Key Record Dates
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