Baxter starts cell-based flu study

By Elaine Rigoli

Tampa, Fla., July 5 - Baxter International, Inc. has started a phase 1/ 2 clinical trial to test the company's vero-cell based candidate H5N1 pandemic influenza vaccine.

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 3.75 mcg to 30 mcg are being tested in formulations with and without alum as adjuvant.

"Our goal is to produce a safe and efficacious pandemic vaccine and demonstrate the advantages that vero-cell based production can offer for manufacturing influenza and other vaccines. 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," vice president of global research and development Noel Barrett said in a news release.

"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," he added.

Baxter said its vero-cell technology is capable of producing high yields of influenza virus without the addition of any animal-derived serum.

Located in Deerfield, Ill., Baxter develops medical devices, pharmaceuticals and biotechnology products.

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