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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Vaccination with 4-valent HPV vaccine in months 0., 2., 6.
National Institute of Child Health
Budapest, Hungary
Papilloma relapses
Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period
Time frame: 18 months after the 3rd vaccine
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