Baxter announces ‘extremely pleasing’ H5N1 vaccine results

Baxter International, the American pharmaceutical company, has announced new phase I/II clinical trial data for a new cell-based H5N1 pandemic vaccine.

The trial was designed to assess the safety and immunogenicity of the vaccine, which was tested in 270 patients in Austria and Singapore. Using the H5N1 strain A/Vietnam/1203/2004, the vaccine was “well tolerated” by humans, while the preliminary results suggested that the vaccine is “highly immunogenic”.

Furthermore, the vaccine was found to be able to provoke a “functional” antibody response at its lowest dosage level, suggesting the neutralisation of the H5N1 strain, in addition to providing protection against the Hongkong/156/97 and Indonesia/05/05 strains of the virus.

Noel Barrett, vice president of global research and development at Baxter, commented: “We are extremely pleased with the clinical results from this study.

“We have achieved an important step toward our goal of producing a safe and efficacious pandemic vaccine using the company’s proprietary vero cell-based technology.”

Professor Frank von Sonnenburg of the University of Munich, chair of the data safety and monitoring board of the trials, said the results were “encouraging” and added that if they are confirmed in phase III trials, the vaccine could represent a “major contribution” to public health.

GlaxoSmithKline (GSK) and Sanofi Pasteur are also researching potential H5N1 vaccine candidates. In July, GSK said it had made a “significant” breakthrough in its attempts to manufacture such a vaccine.