CSL Biotherapies initiates clinical trials of Influenza A/H1N1 2009 vaccine in the US

CSL Biotherapies has announced the initiation of the company’s first U.S. clinical trials of its candidate Influenza A/H1N1 2009 vaccine. Study investigators will administer vaccinations to the first U.S. study volunteers today, August 24. The studies will determine the safety of CSL’s candidate vaccine and its ability to elicit an immune response (also referred to as immunogenicity) in adults and children. The pediatric study will evaluate CSL’s candidate vaccine in a thimerosal-free (i.e., preservative-free) formulation.

The clinical studies are sponsored by CSL Biotherapies and are being funded in whole or in part with Federal funds from the U.S. Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority. They will take place at 24 study sites throughout the country. It is anticipated that findings from these trials will be used to determine the most appropriate dosing schedule of the Influenza A/H1N1 2009 vaccine for use in the general population. This clinical trial program is part of a larger, global effort by CSL Biotherapies, in partnership with government and regulatory bodies, to bring an Influenza A/H1N1 2009 vaccine to market in the United States, in Australia and in select regions of the southern hemisphere.

“The H1N1 pandemic has had a significant toll on the health and well-being of people worldwide, which makes the development of an effective vaccine against the virus an urgent public health need,” said Kawsar Talaat, MD, principal investigator of the CSL vaccine adult trials and assistant scientist in the Johns Hopkins Bloomberg School’s Department of International Health. “Through these trials, we hope to identify the most effective dose and dosing regimen to protect the public against this highly infectious new strain of influenza virus.”

“Children are often at greater risk from influenza infection and its complications than adults, so it is extremely important to understand the efficacy of an H1N1 vaccine in this very vulnerable population,” said Pedro Piedra, MD, principal investigator for the vaccine pediatric trials and professor in the department of molecular virology and microbiology, and pediatrics at Baylor College of Medicine. “The clinical trials of CSL’s candidate vaccine will be the first to use a thimerosal-free formulation of the H1N1 vaccine antigen.”