Extract

High Immune Response Seen with Novel H5N1 Avian Influenza Vaccine

26 July 2006 (Agence de Presse Medicale for Reuters Health)—A new H5N1 avian influenza vaccine may be filed with regulatory agencies in the coming months, after study results showed that the vaccine elicited a high immune response, even at the lowest dose of antigen tested, vaccine-maker GlaxoSmithKline said.

Early analysis of a clinical trial with 400 healthy volunteers showed that the vaccine elicited a strong seroprotective immune response in >180% of subjects who received 3.8 µg of antigen. “This level of seropro-tection meets or exceeds target criteria set by regulatory agencies for registration of influenza vaccines,” the company added in a statement.

“Efficacy results at these levels of antigen dosage have not been reported for any other H5N1 vaccine in development to date, including those using other adjuvants such as alum,” GlaxoSmithKline continued.

J. P Garnier, GlaxoSmithKline's Chief Executive Officer, said, “These excellent clinical trial results represent a significant breakthrough in the development of our pandemic flu vaccine. This is the first time such a low dose of H5N1 antigen has been able to stimulate this level of strong immune response.”

You do not currently have access to this article.