Phase III, Single-center Clinical Trial to Evaluate the 4-valent HPV Vaccine for the Treatment and Prevention of Recurrent Respiratory Papillomatosis in Children
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Papilloma relapses
Study Overview
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 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 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
dr. med habil Zsófia Meszner PhD
Professor
National Institute of Child Health, Hungary