National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510

A -- RESEARCH & DEVELOPMENT PHASE II AND PHASE II CLINICAL TRIAL OF SHIGELLA VACCINE SOL NICHD-DIR-99-10 POC Mrs. Mya N. Hlaing, Contracting Officer, CMB, NICHD (301)496-4611 WEB: National Institutes of Health, http://www.nih.gov. E-MAIL: National Institutes of Health, mh89m@nih.gov. The National Institute of Child Health and Human Development plans to extend the current contract NO1-HD-5-3226 with Sheba Medical Center, Tel-Hashomer, Israel, using other than full and open competition to continue the phase II and to start directly into the phase III study of Shigella vaccine clinical trial to infants and toddlers. This project is the continuation of the ongoing phase II study (safety and immunogenicity) of Shigella flexneri type 2a EPA and S. Sonnei EPA conjugate vaccines. The determination to use other than full and open competition was made in accordance with USC 253 (c)(1) and is based upon the following factors: 1) Sheba Medical Center has successfully performed the phase II safety and immunogenicitystudy of Shigella vaccines in children 4 to 6 years old and adults. 2) The results of the Phase II study are satisfactory. 3) Sheba Medical Center has very qualified and experienced personnel to conduct the proposed research project. This continuation of Phase II study in infants andtoddlers will be conducted as stated in the current contract statement of work. The purpose of this synopsis is to determine whether there are other sources with the above capabilities to perform the work described above. Capability statements sholud be submitted within 45 days of the publication of this synopsis to Mrs. Mya N. Hlaing, Contracting Officer, CMB, NICHD, NIH, 6100 Executive Blvd., Suite 7A-07, MSC 7510, Bethesda, MD 20892-7510, telephone number (301)496-4611 and FAX number (301)402-3676. (See numbered Note 22) Posted 06/01/99 (W-SN337431). (0152)

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