SOURCES SOUGHT
A -- Safety and Immunogenicity Studies of VI-rEPA COnjugate Vaccine for Typhois Fever in Infants
- Notice Date
- 1/26/2005
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NICHD-2005-10
- Response Due
- 3/15/2005
- Archive Date
- 6/15/2005
- Description
- The National Institute of Child Health and Human Development (NICHD), NIH has a need to evaluate the safety, immunogenicity and compatibility with diptheria, tetanus toxoid and pertussis vaccine (DTP) of an investigational Vi-rEPA conjugate vaccine for typhoid fever when administered to infants in Vietnam. Three groups of infants, composed of 100 healthy full-term newborns each, are planned for this study. The infants will be recruited from mothers of 15 communes in Thanh Thuy District, Phu Tho Province, Vietnam. The NICHD plans to award a contract to National Institute of Hygiene and Epidemiology (NIHE) in Hanoi, using other than full and open competition. NICHD has completed studies of Vi conjugate vaccine for typhoid fever in adults, 5 to 14 year olds and 2 to 4 year olds in 1997 and 1999. However, the evaluation of immunogenicity and safety in infants were not completed as yet. Accordingly, NICHD has a neeed 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 purpose of this synopsis is to determine whether there are other sources with the same capabilities to perform the work described above. Capability statements should be sybmitted within 45 days of the publication of this synopsis to Ms. Mya Nwe Hlaing, Contracting Officer, CMB, NICHD, NIH, 61000 Executive Blvd., Suite 7A-07, MSC 7510, Bethesda, MD 20892-7510. Telephone (301) 435-6958, FAX (301) 402-3676. See Note Number 22.
- Record
- SN00740367-W 20050128/050126211925 (fbodaily.com)
- Source
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