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 3 EFFICACY TRIAL OF TYPHOID VACCINES AND ERADICATION OF TYPHOID FEVER IN VIETNAM SOL NIH-NICHD-2000-04 POC Mya N. Hlaing, Contracting Officer, (301) 435-6958 WEB: National Institute of Health, www.nih.gov. E-MAIL: National Institutes of Health, mh89m@nih.gov. The National Institute of Child Health and Human Development has a need to extend the current contract NO1-HD-7-3269 with Pasteur Institute, Ho Chi Minh City, Vietnam, using other than full and open competition to continue the phase 3 efficacy trial of Typhoid vaccine in Vietnam with children and Phase 1 and 2 evaluations of O-acetyl pectin-rEPA conjugate vaccine and a total eradication of typhoid fever in Vietnam. This phase 3 efficacy trial is the continuation of the ongoing Phase 3 efficacy trial of typhoid vaccines which started in September 30, 1997. The NICHD is also planning to include the evaluations of O-acetyl pectin-rEPA conjugate and also a total eradication of typhoid fever in Vietnam at the same time. 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) Pasteur Institute and its subcontractor, Huu Nghi Hospital have successfully performed the Phase 2&3 efficacy trials; 2) The present contractor, Pasteur Institute and the subcontractor have completed an active surveillance of the typhoid fever and already vaccinated a large number of children; 3) Pasteur Institute and the subcontractor maintain very qualified and experienced personnel to conduct the proposed study; 4) They already have the required population for the study. The continuation of Phase 3 study was also stated in the statement of work of the current contract. 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 whould be submitted within 45 days of the publication of this synopsis to Mrs. Mya N. Hlaing, Contracting Officer, CMBG, NICHD, NIH, 6100 Executive Blvd., Suite 7A-07, MSC 7510, Bethesda, MD 20892-7510, telephone (301) 435-6958, FAX (301) 402-3676. (See Numbered Note 22). This synopsis is the revised notice of the previous synopsis under the same Synopsis number NICHD 2000-04. Posted 12/07/99 (W-SN406345). (0341)

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