Phase IIIb Study of Recombinant Tetravalent HPV Vaccine in Patients With Recurrent Respiratory Papillomatosis
In our previous studies we have documented that in patients with RRP the level of
HPV-specific antibodies is low and increases only after numerous surgery procedures.
Therefore the application of this vaccine to patients with RRP can stimulate increased level
of antibodies in the blood as well as presence of virus-specific neutralization antibodies
on the surface of upper aero digestive tract and neutralize viruses shed from new papillomas
and in this way protect patient from spreading of the infection as well as to facilitate the
decrease of load of infectious virus shed from the lesion. This can possibly lead to the
inhibition of growth of the papillomatous lesion.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
occurrence or frequency of recurrences of laryngeal papillomatosis
The main aim is to evaluate the effect of tetravalent HPV vaccine on occurrence or frequency of recurrences of laryngeal papillomatosis.
Ruth Tachezy, PhD.
Institute of Hematology and Blood Transfusion
Czech Republic: State Institute for Drug Control