Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase IIIb Study of Recombinant Tetravalent HPV Vaccine in Patients With Recurrent Respiratory Papillomatosis

Conditions
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Squamous Papilloma of the Larynx

Intervention / Treatment
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* Biological: Silgard


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine Silgard<br>vaccination with tetravalent antiviral vaccine, 3 doses | Biological: Silgard<br>* vaccination with tetravalent antiviral vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV type present in the tissue | We will determine the type of human papillomavirus present in the surgically removed tissue. | 2 years | 
| the presence of HPV specific antibodies | We will evaluate the presence of HPV-specific antibodies in sera of patients with recurrent papillomatosis before and after vaccination. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, recurrent respiratory papillomatosis, antibodies