HPV vaccine for the treatment and prevention of recurrent laryngeal papillomatosis, which is a bening tumor in the upper airways caused by HPV
- Conditions
- Recurrant respiratory papillomatosisTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2013-003049-41-HU
- Lead Sponsor
- ational Institute of Child Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•minimum 10, max 20, otherwise healthy children, above the first year of life, with minimum 3 relapses of Recurrant Respiratory Papillomatosis could be involved
•who underwent ear-nose-throat and oesophagoscopy examination to establish the diagnosis of RRP with or without oesophageal involvement
•whose previously removed papillomas were pozitive for HPV 6, or 11, or both
•who are able to mount neutralizing antibodies
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•other chronic underlying condition,
•other HPV type,
•no antibody response
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •to immunize with the 4-HPV vaccine children with RRP (with at least 3 relapses necessitating surgery) and follow the clinical course for two years after the first dose given<br>•to assess prior and after the third 4-HPV dose certain humoral and cellular immune parameters, virus specific antibodies, INF-gamma, granzyme B tests)<br>•to reduce surgical intervention after vaccination;Secondary Objective: Not applicable;Primary end point(s): Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period;Timepoint(s) of evaluation of this end point: 6th, 12th 18th months after the 3rd vaccine dose
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable