4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01995721|
Recruitment Status : Unknown
Verified November 2013 by dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary.
Recruitment status was: Not yet recruiting
First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process.
After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Respiratory Papillomatosis||Biological: 4-valent HPV vaccine||Phase 3|
- ear-nose-throat (ENT) examination + oesophagoscopy
- assessment of selected humoral (antibodies) and
- cellular immune response parameters(INF gamma and granzyme B testing)
- in vitro and in vivo stimulation of PMBCs with the HPV-4 vaccine
- Immunization with 4-valent HPV vaccine at 0,2,6 months
- 1 month after 3rd vaccine dose - immunological assessment (same tests as in the enrollment phase)
- 6, 12 and 18 months after the 3rd vaccine dose - ENT + oesophagoscopy
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III, Single-center Clinical Trial to Evaluate the 4-valent HPV Vaccine for the Treatment and Prevention of Recurrent Respiratory Papillomatosis in Children|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||February 2017|
Experimental: 4-valent HPV vaccine
4-valent HPV vaccine administered in months 0., 2., 6.
Biological: 4-valent HPV vaccine
Vaccination with 4-valent HPV vaccine in months 0., 2., 6.
- Papilloma relapses [ Time Frame: 18 months after the 3rd vaccine ]Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period
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): NCT01995721
|Contact: Zsofia Meszner, MD, PhD||+36 1 365 firstname.lastname@example.org|
|National Institute of Child Health||Not yet recruiting|
|Budapest, Hungary, 1113|
|Contact: Zsofia Meszner +36 1 365-1540 email@example.com|
|Principal Investigator: Zsofia Meszner, MD, PhD|
|Principal Investigator:||Zsofia Meszner, MD, PhD||National Institute of Child Health|