Director, USAMRAA, 820 Chandler St, Fort Detrick, MD 21702-5014

A -- DEVELOPMENT & PRODUCTION OF A LEISHMANIA SKIN TEST SOL DAMD17-99-R-0050 POC Cheryl R. Miles, Tel: 301-619-7148, Fax: 301-619-3166 E-MAIL: Click here to contact the POC via e-mail., cheryl.miles@amedd.army.mil. The U.S. Army Medical Research and Materiel Command (USAMRMC) intends to award a contract for a Food and Drug Administration (FDA) approved Leishmania Skin Test (LST) to rapidly screen U.S. Service Members who may have been exposed to Leishmania that causes cutaneous disease. When used as a skin test, components of Leishmania parasites stimulate a Delayed Type Hypersensitivity response in individuals previously infected with Leishmania. The disease leishmaniasis is caused by a number of species of protozoan parasites from the genus Leishmania. These protozoans are transmitted to humans from the bite of an infected female sandfly and appears in humans with two disease manifestations: disease of the skin and mucous membranes, and as a visceral disease caused by multiplication of the protozoan in the internal organs. The U.S. Army has performed a small dose ranging and safety clinical study with a Leishmania tropica Lysate Skin Test Antigen. In this study some volunteers appeared to be allergic to the lowmolecular weight dextran used in the lyophilization formulation. For safety reasons, it was decided to reformulate the components into a stable liquid preparation. The government will provide the master seed from whole promastigotes from Leishmania tropica (WR1063). The contractor will be responsible for expanding this master seed for development/ production requirements and shall be the license holder of the Biologics License Application (BLA) required for FDA licensure for human use of the LST. The overall objective of this RFP is to develop a Leishmania Skin Test (LST) intradermal skin test that meets measurements of efficacy and safety which are required to obtain FDA licensure for human use. The Contractor shall develop a real time shelf life protocol and conduct real time shelf life testing acceptable to the FDA to validate a shelf life of at least three years for all reagents and other components of the LST when stored at 2-8 degrees Celsius. The Contractor shall prepare the Chemistry, Manufacturing, and Control Data (CMC) section for the new Investigational New Drug Application for the LST and submit to the FDA the Biologics License Application (BLA) required for FDA licensure for human use for the LST. The Government anticipates the award of a five-year contract, with an Option Year for the Initial Production Run. Interested parties can request a copy of the solicitation by submitting their company's name, address, phone no., fax no. and e-mail address to the contracting office. Posted 10/07/99 (W-SN390143). (0280)

Loren Data Corp. http://www.ld.com (SYN# 0006 19991012\A-0006.SOL)