Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis
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ClinicalTrials.gov Identifier: NCT01375868 |
Recruitment Status :
Completed
First Posted : June 17, 2011
Last Update Posted : January 9, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Squamous Papilloma of the Larynx | Biological: Silgard | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | N/A |
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 |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | December 2018 |
Actual Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Vaccine Silgard
vaccination with tetravalent antiviral vaccine, 3 doses
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Biological: Silgard
vaccination with tetravalent antiviral vaccine |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375868
Czechia | |
Institute of Hematology and Blood Transfusion | |
Prague, Czechia, 128 20 |
Principal Investigator: | Ruth Tachezy, PhD. | Institute of Hematology and Blood Transfusion |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Ruth Tachezy, PhD., M.Sc., PhD., Institute of Hematology and Blood Transfusion, Czech Republic |
ClinicalTrials.gov Identifier: | NCT01375868 |
Other Study ID Numbers: |
UHKT-RLP/2011 2011-002667-14 ( EudraCT Number ) |
First Posted: | June 17, 2011 Key Record Dates |
Last Update Posted: | January 9, 2019 |
Last Verified: | January 2019 |
HPV recurrent respiratory papillomatosis antibodies |
Respiratory Tract Infections Papillomavirus Infections Papilloma Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Infections Respiratory Tract Diseases DNA Virus Infections Virus Diseases Tumor Virus Infections |