Title
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
Phase
Phase 3Lead Sponsor
National Institute of Child Health, HungaryStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Recurrent Respiratory PapillomatosisIntervention/Treatment
human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant ...Study Participants
20Recurrent 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.
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
Vaccination with 4-valent HPV vaccine in months 0., 2., 6.
4-valent HPV vaccine administered in months 0., 2., 6.
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
