None listed
Conditions
Brief summary
The primary purposes of this study are: 1). To test whether HPV 6 virus like particles given as a vaccine are therapeutic for (ie prevent recurrence after conventional destructive treatment, or prolong the interval to recurrence after conventional destructive treatment) recurrent respiratory papillomatosis. 2). To confirm that this experimental vaccine is safe when used in this way. The vaccine is designed to encourage the body’s defences against infection to attack cells infected by HPV. This study will test different doses of the vaccine to see if they work.
Interventions
The investigational vaccine human papilloma virus like particles (HPV VLPs) will be administered intramuscularly into the deltoid area of the arm. Subjects are scheduled to receive three doses with approximately 4 weeks apart.
The study includes two phases: In the first open label dose escalation phase, 6 subjects will receive, sequentially, at 4 week intervals, 1mcg, 5mcg and 25mcg of the investigational vaccine, presuming for that patient that each previous dose produces no more than grade 2
The investigational vaccine human papilloma virus like particles (HPV VLPs) will be administered intramuscularly into the deltoid area of the arm. Subjects are scheduled to receive three doses with approximately 4 weeks apart. The study includes two phases: In the first open label dose escalation phase, 6 subjects will receive, sequentially, at 4 week intervals, 1mcg, 5mcg and 25mcg of the investigational vaccine, presuming for that patient that each previous dose produces no more than grade 2-local or systemic reactivity. Symptomatology will be evaluated after each injection, before a decision is made whether to give the next higher dose. Following scale will be used to grade the severity of symptoms the subject experiences following vaccination: 0- (no adverse events); 1- Mild (does not interfere with daily activities); 2- Moderate (interfere with routine activities) and 3- Severe (unable to perform routine activities). When 6 subjects have completed the first phase dose ranging study, a single dose will be selected for the second phase of the study – this will be the largest dose that produces an acceptable safety profile in the first phase. 12 subjects will get the vaccine, or a placebo, on three occasions. A placebo is something that looks like the vaccine but is not likely to have any effect. In this phase, 12 subjects will be randomized in blocks to receive the selected dose of vaccine or placebo. Neither the subject nor the research staff will know if the subject is receiving the vaccine or the placebo throughout the duration of the study. The anticipated trial duration will be from 01/11/2006 to 30/05/2008.
Sponsors
Centre for Immunology and Cancer Research, University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
1 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Otherwise healthy patients. Recurrent respiratory papillomatosis confirmed on laryngoscopy and by biopsy, with written case notes documenting the course of disease over the last year. Disease sufficiently severe to have required at least 3 documented excisional /ablative treatments over the 12 months prior to admission to the study. Consent from the parents after discussion with the treating paediatrician, and the third party specialist paediatrician.
Exclusion criteria
Patients have hypersensitivity to any component of the vaccine or patients currently (or within three months prior to enrolment) taking systemic immunosuppressive or immunodulative medication wart therapy.
Outcome results
None listed