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FBO DAILY ISSUE OF JULY 03, 2005 FBO #1315
SOLICITATION NOTICE

A -- Pneumococcal Vaccine Project in Fiji

Notice Date
7/1/2005
 
Notice Type
Solicitation Notice
 
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 Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
 
ZIP Code
20892-7612
 
Solicitation Number
RFP-NIH-NIAID-DMID-05-50
 
Response Due
8/14/2005
 
Archive Date
8/29/2005
 
Point of Contact
Liem Nguyen, Contract Specialist , Phone 301-451-3687, Fax 301-402-0972, - Robert Singman, Contract Specialist, Phone 301-451-2607, Fax 301-480-4675,
 
E-Mail Address
ln18x@nih.gov, RSingman@niaid.nih.gov
 
Description
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, intends to negotiate on a sole source basis with the University of Melbourne, Australia (the incumbent) for the completion of a Phase II clinical trial of pediatric subjects in Fiji under the authority of 41 U.S.C. 253(c) (1), as set forth in FAR 6.302-1. The incumbent shall provide a continuation of a Phase II pneumococcal conjugate vaccine clinical trial for the enrollment of additional 200-300 subjects. With the enrollment of the additional subjects, this increase will allow the clinical trial to attain statistically significant and clinically meaningful data. The incumbent will revise their protocol and study documents to determine a safe and efficacious vaccination regimen for Fiji, using a lesser number of pneumococcal conjugate vaccine doses accompanied by a plain 23-valent pneumococcal polysaccharide vaccine to broaden the immune response. The current US-licensed seven-valent pneumococcal polysaccharide conjugate vaccine (Prevnar) is highly efficacious in preventing vaccine serotype disease. However, this conjugate vaccine is licensed with a four dose primary series and is expensive, costing approximately USD $200/infant. If used in the recommended dose regimen, it would consume a large portion of a developing country’s health budget. Cost is a primary reason many countries have not yet introduced pneumococcal conjugate vaccination and they are seeking alternative regimens that will be both efficacious and affordable. The incumbent (University of Melbourne) currently has 228 subjects enrolled in the study. The subjects enrolled in the trial are scheduled to receive their 12-month vaccination in early September 2005. The incumbent must administer the next dose of vaccine in order to assure the health and safety of the subjects. If the 12-month vaccination is not administered, there are potential ethical ramifications for the subjects, parents and guardians and their participation in future research. Moreover, not providing the 12-month vaccination will result in a loss of vital clinical and safety data for the currently enrolled subjects. The incumbent will work with the NIAID staff to revise a protocol and study documents to complete the Phase II clinical trial, including assaying samples, analyzing results, and generating a final report. The proposed award represents a continuation of work originally awarded to the University of Melbourne in 2002. Institutions which believe they have the requisite ability to perform this requirement may provide a capability statement identifying their business type e.g. educational institution, small business, large for-profit, etc. and a contact person and phone number within 45 days of this announcement. See Numbered Notes 22 and 26. No collect calls will be accepted. Questions regarding this action may be submitted to Liem T. Nguyen on 301-451-3687. NOTE: THIS NOTICE WAS NOT POSTED TO WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (01-JUL-2005); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
 
Web Link
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NIAID/RFP-NIH-NIAID-DMID-05-50/listing.html)
 
Place of Performance
Address: Various Sites
Country: Fiji
 
Record
SN00840589-F 20050703/050701211641 (fbodaily.com)
 
Source
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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