Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis
Vaccines against human papillomaviruses are now commercially available. One of the commercial vaccine contains antigens of both LR HPV types which cause virtually all cases of RRP. Clinical trials have documented the safety and immunogenicity of this vaccine as well as its effectiveness in prevention of incident and persistent infection of the vaccinal types as well as a development of lesions caused by these types. After vaccination the antibodies level increases dramatically and the high levels of antibodies are present in the blood still after 6 years. Furthermore, the neutralization antibodies to the vaccinal antigens have been detected in the cervical mucus of vaccinated women. The preliminary data are now available showing the presence of HPV-specific antibodies in the oral cavity in women after vaccination. The level of antibodies has been dependent on time since vaccination.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase IIIb Study of Recombinant Tetravalent HPV Vaccine in Patients With Recurrent Respiratory Papillomatosis|
- occurrence or frequency of recurrences of laryngeal papillomatosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]The main aim is to evaluate the effect of tetravalent HPV vaccine on occurrence or frequency of recurrences of laryngeal papillomatosis.
- HPV type present in the tissue [ Time Frame: 2 years ] [ Designated as safety issue: No ]We will determine the type of human papillomavirus present in the surgically removed tissue.
- the presence of HPV specific antibodies [ Time Frame: 5 years ] [ Designated as safety issue: No ]We will evaluate the presence of HPV-specific antibodies in sera of patients with recurrent papillomatosis before and after vaccination.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: Vaccine Silgard
vaccination with tetravalent antiviral vaccine, 3 doses
vaccination with tetravalent antiviral vaccine
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.
|Institute of Hematology and Blood Transfusion|
|Prague, Czech Republic, 128 20|
|Principal Investigator:||Ruth Tachezy, PhD.||Institute of Hematology and Blood Transfusion|