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 -- PHASE II CLINICAL TRIAL OF E COLI VACCINE IN CHILDREN SOL NICHD-DIR-99-09 POC 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 award a contract to the Carolinas Medical Center, Charlotte, North Carolina, using other than full and open competition to perform the phase 2 study of E. coli 0157 -- rEPA in children 2-4 years of age which is an extension of Phase I study which Carolinas Medical Center completed successfully in 1995. 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) The Carolinas Medical Center had performed the clinical evaluation of the first investigational vaccine for E. coli 0157 for NICHD in 1993 and successfully completed in 1995. They had recruited 87 of 90 adult volunteers for the study. 2) The Carolinas Medical Center has an excellent plan for for recruiting volunteers for the E. coli vaccine study in adults as well as in other studies. 3) The Center has a well established research program with the necessary staff: physicians, research nurses, technicians, secretarial and data entry clerks. 4) The pediatric physicians of the Infectious Disease Department of Carolinas Medical Center are requiring diarrheal stool specimens to be analyzed for E. coli 0157. The laboratory facilities and personnel are skilled in this area. Phase I study was successful and found the vaccine to be safe with adults. The proposed study is the continuation of the vaccine study which is a Phase II study of of E. coli vaccine in children 2-4 years of age. 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 should be submitted be 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 05/28/99 (W-SN337169). (0148)

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