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PharmAthene Presents New Data for Lyophilized rPA Anthrax Vaccine Showing Enhanced Immunogenicity
Date:7/15/2010

s of Health (NIH) and at the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services, to advance these important medical countermeasures to protect Americans at home and on the battlefield."

Lyophilized rPA Findings Reported

The study, which was funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, was designed to assess if PharmAthene's lyophilized rPA vaccine reconstituted at point-of-use produced a more robust immune response than liquid rPA vaccine and whether the immune response from the lyophilized rPA changed over time following reconstitution.  

In the study, one group of New Zealand White rabbits (NZW) received liquid rPA (1.0 microgram dose) stored at 2-8 degrees Celsius via intramuscular injection on days 1 and 29.  The remaining four groups of NZW rabbits received lyophilized rPA (1.0 microgram dose) stored at 2-8 degrees Celsius, reconstituted and administered via intramuscular injection on days 1 and 29.  Blood samples were collected pre-dose and on days 15, 29 and 43 for measurement by toxin neutralization assay (TNA) and enzyme linked immunosorbent assay (ELISA) for the presence of IgG anti-PA antibodies.  

Results demonstrated that lyophilized rPA vaccine, reconstituted at less than 2 hours prior to use, was more immunogenic than the liquid rPA vaccine when measured by both TNA and ELISA (p<0.05).  The study investigators concluded that lyophilized rPA reconstituted at point-of-use was more immunogenic than liquid rPA and produced a robust immune response after only 2 doses.  

"We're very encouraged by this preliminary study," continued Dr. Riddle.  "The initial non-clinical animal data suggest that a lyophilized rPA va
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SOURCE PharmAthene, Inc.
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