Recurrent Respiratory Papillomatosis Clinical Trial
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
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.
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
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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