
“Pandemic Core Dossier”:
In May 2006, we announced the commencement of a large Phase I clinical trial to test a vaccine against avian influenza in humans, in collaboration with the University Hospitals of Leicester. Three types of vaccine will be tested for safety and immunogenicity, all based on the H9N2 virus: a non-adjuvanted whole virion vaccine, an alum-adjuvanted whole virion vaccine and a virosomal subunit vaccine. Trials with subtypes of influenza A with pandemic potential, such as H9N2, can be used in support of a “pandemic core dossier”, which forms the basis for rapid approval by the regulatory authority of a vaccine against an actual pandemic threat once it emerges. The study will allow Crucell to investigate several options to lower the amounts of antigen per dose by exploring different adjuvants and routes of immunization. It will also guide us in determining how to make an effective vaccine against any avian flu strain, including H5N1.
Phase I and II studies have been completed and the results are currently being analyzed. No serious adverse side effects were reported to date. Findings are expected to be released first half of 2008.
FLUPAN:
In Europe, Crucell and sanofi pasteur combined as the only manufacturer for the FLUPAN program. FLUPAN intends to enhance EU preparedness for an influenza pandemic by improving on existing vaccine production techniques through the development of novel cell-based vaccines. Phase I clinical trials for the pandemic flu vaccine have started in September 2006. The study is completed and the vaccine was found to be sound, safe and well tolerated as presented during the "Options for the Control of Influenza VI Conference" held in Toronto, Canada, June 2007.
US Government Initiative:
In April 2005, sanofi pasteur, with Crucell as a subcontractor, received a US$ 97 million contract by the US Department of Health and Human Services (HHS) for clinical development of PER.C6®-based influenza vaccine and other related activities. (See the sanofi pasteur website.) The objective of the contract is to accelerate the licensure in the U.S. of a PER.C6®-based cell-culture influenza vaccine and vaccine manufacturing facility. The project is part of the U.S. government's effort to increase influenza vaccine manufacturing capacity in the event of a pandemic or other influenza health emergency.
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