Intercell reports Phase II Study Results of its Vaccine Enhancement Patch for Pandemic Influenza

05-Jul-2010 - Austria

Intercell AG announced the results of a Phase II clinical trial of its investigational Vaccine Enhancement Patch (VEP) system for avian H5N1 influenza. In this development program, Intercell is working under a 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 against pandemic influenza that combines a H5N1 vaccine with Intercell’s LT adjuvant patch.

Following encouraging pre-clinical and clinical Phase I proof-of-concept trials conducted under this HHS contract, the clinical Phase II study was designed to determine the safety and the optimal combination/dose of an injectable H5N1 influenza vaccine (30 and 45 µg antigen) and Intercell’s VEP (50 and 100 µgLT adjuvant) applied at the injection site. A total of 500 healthy adults were recruited in 6 study groups.

The study did not identify the optimal combination of antigen and adjuvant because no statistically significant difference in seroprotection rates as measured by Haemagglutinin Inhibition (HI) assay was observed when comparing groups with and without VEP.

However, the study results demonstrated a good safety profile for all doses of injectable vaccine and adjuvant patches studied. Furthermore, a dose-dependent response to the H5N1 antigen was observed. Anti-LT IgG titers in study subjects receiving the patch confirmed that Intercell’s VEP could consistently deliver the vaccine adjuvant.

Intercell intends to conduct further clinical evaluation using its VEP in combination with an injectable H5N1 vaccine to be supplied by GlaxoSmithKline (GSK) as part of a collaborative agreement signed in December 2009.

https://www.bionity.com/en/news/119701/intercell-reports-phase-ii-study-results-of-its-vaccine-enhancement-patch-for-pandemic-influenza.html