MedImmune Inc., of Gaithersburg, Md., said Friday that it filed aninvestigational new drug application for a Phase I study of its Lymedisease vaccine, MEDI-490.The vaccine is a recombinant version of Bacille Calmette-Guerin(BCG), a live bacterium that has been used for more than 50 years toimmunize people against tuberculosis. It is designed to present outersurface protein A (osp A) to the immune system. A July 1993 article inthe Journal of Experimental Medicine reported that it prevented Lymedisease in a mouse model.The trial will be conducted at the University of Maryland Center forVaccine Development in Baltimore. Thirty-six healthy adults will beenrolled in the study, and split into six dosing groups, one of whichwill be given non-recombinant BCG as a control. Half of the patients ineach MEDI-490 group will receive a booster immunization at sixmonths.The primary goals are to test the safety of MEDI-490 and to testimmune response at different dose levels."Based on preclinical results we have seen, MEDI-490 may have thepotential to generate a more potent and longer lasting immune responsethan other Lyme disease vaccines under development," said JamesYoung, vice president, research and development, of MedImmune.MedImmune (NASDAQ:MEDI) stock closed Friday at $8.88 per share,up 13 cents. - Jim Shrine
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