Date: 2011-05-04
Type of information:
phase: 1
Announcement: initiation
Company: Intercell (Austria) GSK (UK)
Product: Vaccine Enhancement Patch in combination with GSK's H5N1 pandemic Influenza antigen
Action mechanism: vaccine
Disease: pandemic influenza
Therapeutic area: Infectious diseases
Country:
Trial
details: The confirmatory trial will be performed under a Phase I protocol due to the introduction of a different H5N1 antigen. The study will involve 300 healthy adults and investigate various combinations of antigen and patch doses in one and two injection regimes to confirm mode of action and the value of external adjuvantation. GSK's adjuvanted and licensed H5N1 vaccine will be used to provide a positive control for the patch and GSK's well established and validated H5N1 hemagglutination inhibition (HI) assay will be applied.
Latest
news: Intercell has announced the start of a further trial in the field of pandemic Influenza, investigating Intercell's adjuvant patch (Vaccine Enhancement Patch - VEP) containing LT (a heat-labile toxin from E. coli) in combination with GSK's H5N1 pandemic antigen. This trial follows prior work with a non-GSK pandemic Influenza antigen carried out by Intercell under its contract with the U.S. Department of Health and Human Services (HHS) to develop a dose sparing approach with potential for a single dose immunization.
