CSL Initiates US H1N1 Vaccine Clinical Trials

CSL Biotherapies (CSL) has initiated the US clinical trials of its candidate Influenza A/H1N1 2009 vaccine.

Reportedly, 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 formulation.

Moreover, 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.

The clinical trial program is part of a larger, global effort by CSL Biotherapies, in partnership with government and regulatory bodies, to bring this vaccine to markets in the US, Australia and in select regions of the southern hemisphere.

Kawsar Talaat, 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.”