A -- PHASE I AND PHASE II SAFETY AND IMMUNOGENICITY OF CLINICAL TRIALS OF THE O-ACETY; PECTIN AND RECOMBINANT EXOPROTEIN CONJUGATE, A SEMI-SYNTHETIC TYPHOID CONJUGATE VACCINE

Notice Date

August 20, 2001

Contracting Office

National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510

ZIP Code

20892-7510

Solicitation Number

HD-01-011

Point of Contact

Mya N. Hlaing, Contracting Officer, Contracts Management Branch, NICHD, NIH (301) 435-6958

E-Mail Address

Contact the NICHD Contracting Officer (mh89m@nih.gov)

Description

The National Institute of Child Health and Human Development (NICHD), National Institutes of Health is planning to award a contract to Paramedical School, Phu Tho City, Vietnam, using other than full and open competition to study the safety and immunogenicity of the new semi-synthetic conjugate vaccine using an O-acetylated pectin as the Vi source in a high endemic area. These two phases, Phase I and II will take one year and will involve about 50 healthy volunteers, 18-35 years old and 50 school age children, 5-14 years old. The determination to use other than full and open competition was made in accordance with 41 USC 253 (c) (1), and is based upon the following: 1) Phu Tho City area has a high incidence of typhoid fever, so that the number of subjects required to show statistically significant efficacy will be relatively small, 2) Phu Tho City is a community that has an infrastructure to conduct disease surveillance and case identification, 3) the choice area is a medical community that is competent in the clinical diagnosis and laboratory confirmation of cases. In addition, NICHD has a precise immunogenicity data from Vietnam that can be used to compare to this new radical vaccine. The purpose of this synopsis is to determine whether there are other sources with the requisite qualifications to perform the proposed study. An organization capable of performing the task should submit a statement of capabilities with documentation supporting its ability within 45 days of this notice to: Mya N. Hlaing, Contracting Officer, CMB, NICHD, 6100 Executive Boulevard, Suite 7A-07, MSC 7510, Bethesda, MD 20892-7510 (See Note Numbered 22)

Web Link

NICHD Contracts Office (www.nih.gov)

Record

Loren Data Corp. 20010822/ASOL013.HTM (W-232 SN50V4E6)