4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- respiratory papillomatosis
- 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
- HPV 6 and/or 11 positive papillomas
Exclusion Criteria
- other chronic underlying condition
- no antibody response
- other HPV type
- other chronic underlying condition
- no antibody response
- other HPV type
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 Criteria
- respiratory papillomatosis
- 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
- HPV 6 and/or 11 positive papillomas
Exclusion Criteria
- other chronic underlying condition
- no antibody response
- other HPV type
- other chronic underlying condition
- no antibody response
- other HPV type
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