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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 National Institute of Child Health, Hungary.
Recruitment status was:  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary
ClinicalTrials.gov Identifier:
NCT01995721
First received: November 20, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted

November 20, 2013
November 20, 2013
February 2014
February 2017   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children
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.

  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
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Respiratory Papillomatosis
Biological: 4-valent HPV vaccine
Vaccination with 4-valent HPV vaccine in months 0., 2., 6.
Other Names:
  • Silgard
  • Gardasil
Experimental: 4-valent HPV vaccine
4-valent HPV vaccine administered in months 0., 2., 6.
Intervention: Biological: 4-valent HPV vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
February 2017
February 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
1 Year to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
 
NCT01995721
50934
No
Not Provided
Not Provided
Not Provided
dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary
National Institute of Child Health, Hungary
Merck Sharp & Dohme Corp.
Principal Investigator: Zsofia Meszner, MD, PhD National Institute of Child Health
National Institute of Child Health, Hungary
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP