Baxter initiates avian flu trial

The study is being conducted with several hundred healthy adults in Austria and Singapore using the fully inactivated wild-type H5N1 strain A/Vietnam/1203/2004. Four different antigen concentrations ranging from 3.75mcg to 30mcg are being tested in formulations with and without alum as adjuvant.

“The study will provide us with critical data concerning the vaccine dosage required to induce protective immune responses, and information about the ability of a vaccine, based on a single H5N1 strain, to induce protective immune response against a range of different H5N1 strains,” said Noel Barrett, vice president of global R&D for Baxter’s vaccines business. “Preclinical studies in animal models have shown very good cross-protection to date, and we are looking forward to confirming this with studies in humans.”

Baxter is developing both seasonal (or inter-pandemic) and pandemic influenza vaccines based on the company’s proprietary vero-cell technology, which has the potential to significantly reduce production time compared to traditional vaccine production methods that use embryonated hens’ eggs.

Baxter is working with the US National Institute of Allergy and Infectious Diseases (NIAID), in partnership with Fisher BioServices, and with the US Department of Health and Human Services in partnership with DVC LLC, a CSC company, to develop vero-cell based H5N1 pandemic and seasonal influenza candidate vaccines. Both collaborations are the result of US government contract awards.