Overview

This trial is active, not recruiting.

Condition squamous papilloma of the larynx
Treatment silgard
Phase phase 3
Sponsor Ruth Tachezy, PhD.
Collaborator Medical Healthcom Prague
Start date October 2011
End date December 2018
Trial size 50 participants
Trial identifier NCT01375868, 2011-002667-14, UHKT-RLP/2011

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
vaccination with tetravalent antiviral vaccine, 3 doses
silgard
vaccination with tetravalent antiviral vaccine

Primary Outcomes

Measure
occurrence or frequency of recurrences of laryngeal papillomatosis
time frame: 5 years

Secondary Outcomes

Measure
HPV type present in the tissue
time frame: 2 years
the presence of HPV specific antibodies
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Patients with RRP which sign the informed consent form with both parts of the study will be enrolled. Exclusion Criteria: Patients who experience severe side effects of vaccination after the first or second dose will not be vaccinated with the third dose and they will be excluded from the study. Patients who will not receive all three doses within one year and 30 days will be also excluded.

Additional Information

Official title Phase IIIb Study of Recombinant Tetravalent HPV Vaccine in Patients With Recurrent Respiratory Papillomatosis
Principal investigator Ruth Tachezy, PhD.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Institute of Hematology and Blood Transfusion, Czech Republic.