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

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

  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

Sponsor: National Institute of Child Health, Hungary

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institute of Child Health, Hungary

Dates:
Date Received: November 20, 2013
Date Started: February 2014
Date Completion: February 2017
Last Updated: November 20, 2013
Last Verified: November 2013