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 -- CLINICAL EVALUATION OF THE SAFETY, IMMUNOGENICITY AND EFFICACY IN CHILDREN IN AN ENDEMIC AREA OF THE INVESTIGATIONAL VACCINE DESIGNED TO PREVENT SHIGELLOSIS SOL NO1-HD-5-3226 POC Mya N. Hlaing, Contracting Officer, Tel.#(301)496-4611, FAX (301) 402-3676 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 (NICHD) plans to extend the current contract NO1-HD-5-3226 to Sheba Medical Center, Israel, using other than full and open competition to conduct a phase I study in adults of 150 patients and the phase II study of 60 infants-toddlers. Sheba Medical Center has already conducted the shigella vaccines study in children under phase I under the present contract NO1-HD-5-3226. This proposed study is a Phase I study (safety and immunogenicity) of Shigella flexneri 2a-rEPA, S. Flexneri 2a-CRM9, S. Sonnei-CRM9, S.sonnei-rEPA and S.Sonnei-CRM9 conjugate vaccines in adults, ages 18 to 40 will be conducted. 150 healthy adult volunteers will be recruited and informed consent will be obtained. Each vaccine will be injected into 30 adults. A total of 150 adults will be vaccinated. The determination to use other than full and open competition was made in accordance with 41 USC 253 (c) (1). The proposed study will take 12 months of work on the part of the proposed present contractor. If the results of this Phase I study are satisfactory, then the Phase II study will be conducted in children 1-2 years of age using the conjugate or conjugates showing the highest immunogenicity under the existing contract. An organization capable of performing this task without a costly and significant break in work should submit a statement of capabilities with documentation supporting its ability to meet the Government's requirements as described above. The purpose of this synopsis is to determine whether there are other sources with the requisite qualifications to perform the work described above. Capability statements should be submitted within 45 days of the publications of this synopsis to: Mya N. Hlaing, Contracting Officer, Contracts Management Branch, 6100 Executive Building, Suite 7A-07 MSC 7510, Bethesda, Maryland 20892-7510. (See Numbered Note 22). Telephone number (301)496-4611, FAX (301)402-3676 (0110)

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