Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

at least 3 relapses in patient history
able to mount neutralizing antibodies
respiratory papillomatosis
...
at least 3 relapses in patient history
able to mount neutralizing antibodies
respiratory papillomatosis
HPV 6 and/or 11 positive papillomas

Exclusion Criterias

no antibody response
other HPV type
other chronic underlying condition
no antibody response
other HPV type
other chronic underlying condition

Summary

Conditions
Recurrent Respiratory Papillomatosis
Type
Interventional
Phase
Phase 3
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 1 years and 17 years
Gender
Both males and females

Description

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 Immunization with 4-valent HPV...

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 Immunization with 4-valent HPV vaccine at 0,2,6 months 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

Inclusion Criterias

at least 3 relapses in patient history
able to mount neutralizing antibodies
respiratory papillomatosis
...
at least 3 relapses in patient history
able to mount neutralizing antibodies
respiratory papillomatosis
HPV 6 and/or 11 positive papillomas

Exclusion Criterias

no antibody response
other HPV type
other chronic underlying condition
no antibody response
other HPV type
other chronic underlying condition

Locations

Budapest, 1113
Budapest, 1113

Tracking Information

NCT #
NCT01995721
Collaborators
Merck Sharp & Dohme Corp.
Investigators
  • Principal Investigator: Zsofia Meszner, MD, PhD National Institute of Child Health
  • Zsofia Meszner, MD, PhD National Institute of Child Health