Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis
This trial is active, not recruiting.
|Condition||squamous papilloma of the larynx|
|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|
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.
|Intervention model||single group assignment|
vaccination with tetravalent antiviral vaccine, 3 doses
occurrence or frequency of recurrences of laryngeal papillomatosis
time frame: 5 years
HPV type present in the tissue
time frame: 2 years
the presence of HPV specific antibodies
time frame: 5 years
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.
|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.|
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