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news.To evaluate its potential effectiveness in adults and children in select regions of the southern hemisphere
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CSL Biotherapies has announced the initiation of the company’s first US clinical trials of its candidate Influenza A/H1N1 2009 vaccine. The studies are expected to 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 is expected to evaluate CSL’s candidate vaccine in a thimerosal-free (preservative-free) formulation.
It has been reported that the clinical studies are sponsored by CSL Biotherapies and are being funded in whole or in part with Federal funds from the US Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority. It is anticipated that findings from these trials will be used to determine the 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 US, Australia and in select regions of the southern hemisphere.
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, said: “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. 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.”
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, commented: “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. “The clinical trials of CSL’s candidate vaccine will be the first to use a thimerosal-free formulation of the H1N1 vaccine antigen.”