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 3
  • Study Type

  • Status

    Unknown status
  • Study Participants

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.

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 Started
Feb 28
Primary Completion
Feb 28
Study Completion
Feb 28
Last Update
Nov 27

Biological 4-valent HPV vaccine

Vaccination with 4-valent HPV vaccine in months 0., 2., 6.

  • Other names: Silgard, Gardasil

4-valent HPV vaccine Experimental

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
No Results Posted