A -- OHASE I, PHASE II AND PHASE III TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF THE INVESTIGATIVE SHIGELLA VACCINES

Notice Date

April 6, 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-01-007

Point of Contact

Mya Nwe Hlaing, Contracting Officer, Contracts Management Branch, NICHD, (301) 435-6958

E-Mail Address

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

Description

Numbered Notes 22 The National Institute of Child Health and Human Development (NICHD) is planning to award a contract to Henan Institute of Epidemiology and AntiEpidemic, Zhengzhou, Henan Province, Peoples Republic of China, using other than full and open competition to evaluate the safety and immunogenicity of the investigative shigella vaccines, made in Lanzhou, Gansu Province, PRC, using the technology of the Laboratory of Developmental and Molecular Immunity (LDMI), NICHD. These two phases, Phase I and II will take one year and will involve about 720 individuals ranging from young adults, 5 to 7 year-olds and 1 to 4 years-olds. Phase III is an efficacy (safety, immunogenicity and efficacy of these investigative vaccines). These vaccines will pass specifications derived from the Phase I and Phase II studies. 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) The proposed organization has established and organized medical care and immediate access to hospitals; 2) They possess previous history of clinical evaluation of investigative Shigella vaccines, established and accurate surveillance of enteric infections with special experience and skill in identifying Shigella; 3)They also have a history of surveillance to identify the attack rate, age, seasonal and sex distribution of patients with shigellosis. Phase I and II studies will last one year. 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. 20010410/ASOL013.HTM (W-096 SN50I5C4)