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Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis
This study is ongoing, but not recruiting participants.
Sponsor:
Ruth Tachezy, PhD.
Collaborators:
Medical Healthcom Prague
Na Homolce Hospital
Information provided by (Responsible Party):
Ruth Tachezy, PhD., Institute of Hematology and Blood Transfusion, Czech Republic
ClinicalTrials.gov Identifier:
NCT01375868
First received: June 16, 2011
Last updated: September 2, 2016
Last verified: September 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Squamous Papilloma of the Larynx | Biological: Silgard | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Phase IIIb Study of Recombinant Tetravalent HPV Vaccine in Patients With Recurrent Respiratory Papillomatosis |
Resource links provided by NLM:
Further study details as provided by Ruth Tachezy, PhD., Institute of Hematology and Blood Transfusion, Czech Republic:
Primary Outcome Measures:
- occurrence or frequency of recurrences of laryngeal papillomatosis [ Time Frame: 5 years ]The main aim is to evaluate the effect of tetravalent HPV vaccine on occurrence or frequency of recurrences of laryngeal papillomatosis.
Secondary Outcome Measures:
- HPV type present in the tissue [ Time Frame: 2 years ]We will determine the type of human papillomavirus present in the surgically removed tissue.
- the presence of HPV specific antibodies [ Time Frame: 5 years ]We will evaluate the presence of HPV-specific antibodies in sera of patients with recurrent papillomatosis before and after vaccination.
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vaccine Silgard
vaccination with tetravalent antiviral vaccine, 3 doses
|
Biological: Silgard
vaccination with tetravalent antiviral vaccine
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01375868
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375868
Locations
| Czech Republic | |
| Institute of Hematology and Blood Transfusion | |
| Prague, Czech Republic, 128 20 | |
Sponsors and Collaborators
Ruth Tachezy, PhD.
Medical Healthcom Prague
Na Homolce Hospital
Investigators
| Principal Investigator: | Ruth Tachezy, PhD. | Institute of Hematology and Blood Transfusion |
More Information
Publications:
| Responsible Party: | Ruth Tachezy, PhD., M.Sc., PhD., Institute of Hematology and Blood Transfusion, Czech Republic |
| ClinicalTrials.gov Identifier: | NCT01375868 History of Changes |
| Other Study ID Numbers: |
UHKT-RLP/2011 2011-002667-14 ( EudraCT Number ) |
| Study First Received: | June 16, 2011 |
| Last Updated: | September 2, 2016 |
Keywords provided by Ruth Tachezy, PhD., Institute of Hematology and Blood Transfusion, Czech Republic:
|
HPV recurrent respiratory papillomatosis antibodies |
Additional relevant MeSH terms:
|
Papilloma Respiratory Tract Infections Papillomavirus Infections Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Infection |
Respiratory Tract Diseases DNA Virus Infections Virus Diseases Tumor Virus Infections Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 23, 2017