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2011 Call for projects in the field of viral safety for biological products
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Selected projects 2009

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Infectivity titrations of blood components from chimpanzees infected with the agent of Gerstmann-Sträussler-Scheinker Syndrome in mice and comparison of sensitivity of mouse bioassays

PI: L.Gregori
Other Investigators : D. Asher and P. Piccardo
FDA, Laboratory of Bacterial, Parasitic and Unconventional Agents, Division of Emerging and Transfusion-Transmitted Diseases, Office of Blood Research and Review, Rockville - USA

Recognized dietary transmissions of variant Creutzfeldt-Jakob disease (vCJD) have decreased recently, but secondary transmissions by blood transfusion have come to pose a major threat to the continued safety of the blood supply and to the public health.
 An ante-mortem plasma-based vCJD test would be useful to reduce the risk of transmitting the infection via blood transfusions and treatments with human plasma derivatives. One major challenge is to obtain relevant materials for validating candidate tests. To this end, we propose to use plasma from a chimpanzee infected with a form of human transmissible spongiform encephalopathy (TSE) called Gerstmann-Sträussler-Scheinker syndrome (GSS). This plasma has not yet been tested for infectivity, but buffy coat prepared from the same blood transmitted infection to monkeys, so plasma is likely to be infected. Buffy coat and plasma were generously donated to the FDA by Dr. P. Brown. Mice susceptible to GSS will be used to titer infectivity in both buffy coat and plasma. If plasma is infectious, it should be a useful reference standard to validate TSE assays.
In the long term, we are planning to generate large panels of plasma from vCJD-infected macaques to evaluate performance of candidate tests. These vCJD-infected macaque plasma samples will also have to be titrated in the future, so we propose to compare the sensitivity of two wild-type TSE mouse models to infection with vCJD agent in brain suspensions, in order to find appropriate assay mice.

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