HPV VLP as adjunct therapy for recurrent respiratory papillomatosis.

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.