Intercell Starts Clinical Trial in Pandemic Influenza
Product News May 05, 2011
Intercell AG 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.
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.
Intercell and GSK have maintained their commitment to continue to explore the value of the patch technology and will focus on evaluating the use of the patch technology for transcutaneous vaccination with existing or new antigens.
Following the discontinuation of the Travelers’ Diarrhea (TD) patch vaccine program as announced at the end of 2010, Intercell and GSK have mutually terminated the respective marketing and distribution collaboration.
On this basis, all rights on the TD patch vaccine revert back to Intercell. Based on the clinical efficacy data obtained against LT‐positive enterotoxigenic E. coli (ETEC) the company will continue to evaluate the potential of the vaccine candidate especially for endemic countries.
“We are pleased to continue our partnership with GSK to accelerate the development of needle‐free, patch‐based vaccines. We are also looking forward to investigating further the potential of our Vaccines Enhancement Patch (VEP) with this confirmatory clinical study in our pandemic Influenza program,” stated Thomas Lingelbach, Chief Operating Officer of Intercell.