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
|Condition or disease||Intervention/treatment||Phase|
|Squamous Papilloma of the Larynx||Biological: Silgard||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Vaccine Silgard
vaccination with tetravalent antiviral vaccine, 3 doses
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.
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
|Institute of Hematology and Blood Transfusion|
|Prague, Czechia, 128 20|
|Principal Investigator:||Ruth Tachezy, PhD.||Institute of Hematology and Blood Transfusion|