A -- Development, testing and evaluation of a live vaccine strain (LVS) tularemia vaccine candidate

The National Institute of Allergy and Infectious Diseases (NIAID) intends to negotiate, under the authority of 41 U.S.C. 253(c)(1) and FAR 6.302-1, a new one (1) year contract with DynPort Vaccine Company (DVC). DVC has recently developed an updated manufacturing method for a live attenuated bacterial vaccine against tularemia (LVS) and produced a GMP pilot lot suitable for clinical investigation. The product is currently undergoing lot release and preclinical testing in preparation for filing an Investigational New Drug (IND) submission with the FDA. The goals of the contract are to complete ongoing preclinical and product testing of this product and filing an IND, with an option to conduct a phase 1 clinical trial. The planned contract will provide for continued development of the vaccine candidate for a period of one (1) year, using FY04 appropriated funds. Tasks include repeat dose pharmacology and toxicology studies, stability testing of recently manufactured investigational product, production of placebo product for the phase 1 trial, compiling data for IND submission and coordinating the design and possible execution of a phase 1 clinical trial. Inherent duplication of cost to the government and the difficulty in developing a new product make competition unfeasible for this project. See Numbered Note 22. No collect calls will be accepted. Point of Contact Elizabeth Osinski, Contracting Officer, Phone 301-402-6289, Fax 301-402-0972, Email: eo43m@nih.gov. Secondary Point of Contact: Sharon Kraft, Contract Specialist, Phone 301-496-0195, Fax 301-402-0972, Email: skraft@niaid.nih.gov.