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 -- SAFETY AND IMMUNOGENICITY STUDIES OF VI-REPA CONJUGATE VACCINE FOR TYPHOID FEVER IN INFANTS SOL NIH-NICHD-2000-08 POC Mya Nwe Hlaing, Contracting Officer (301) 435-6958 WEB: NICHD Contracts Office, www.nih.gov. E-MAIL: Contact the NICHD Contracting Officer, nichdcmb@mail.nih.gov. The National Institute of Child Health and Human Development (NICHD), NIH has a need to evaluate the safety, immunogenicity and compatibility with Diptheria, tetanus toxoids and pertussis vaccine of Vi-rEPA conjugate vaccine for typhoid fever in infants as part of the routine infant immunization. The NICHD plans to award a contract to Pasteur Institute, Ho Chi Minh City, Vietnam, using other than full and open competition. Pasteur Institute was awarded a contract NO1-HD-5-3227 on June 2, 1995 which was a phase 2 study for the evaluation of immunogenicity and safety of Vi-rEPA conjugate vaccine for typhoid fever. The sequential studies of Vi conjugate vaccine in adults, 5 to 14 year olds and 2 to 4 year-olds were performed in 1997 and 1998. However, the evaluation of immunogenicity and safety in infants were not completed as yet, though the work statement was included in the phase 2 study. Accordingly, NICHD has a need to evaluate the safety, immunogenicity and comparability of Vi-rEPA, injected concurrently with DTP in infants using the Expanded Program on Immunization schedule. The planned study is a continuation of the first two studies of safety and immunogenicity in older children and adults, and a phase 3 clinical efficacy trial in 2-4 years old children. The study in infants is an obligatory step to incorporate Vi-rEPA vaccine into the infant immunization program. The Vietnamese investigators have conducted all phases of vaccine evaluations and they have the necessary expertise and infrastructure to conduct this study. The planned study will be conducted in the same site where the phase 3 efficacy trial is on-going. The health staff in the proposed study communes are familiar with the procedures of vaccine evaluation. In addition, the community has been well sensitized to vaccine studies. Vaccine study has been well accepted by the people and local community leaders in the planned study areas. The purpose of this synopsis is to determine whether there are other sources with the above capabilities to perform the work describe above. Capability statements should 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 (301) 435-6958, FAX (301) 402-3676. See Note number 22) Posted 04/11/00 (W-SN443850). (0102)

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