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COMMERCE BUSINESS DAILY ISSUE OF JUNE 3,1999 PSA#2359Centers for Disease Control and Prevention (CDC), Procurement and
Grants Office, SECTION II, 2920 Brandywine Road, Mailstop K-69,
Atlanta, GA 30341-4146 A -- CONDUCT AND EVALUATION OF ON-GOING PHASE III HIV VACCINE EFFICACY
TRIALS SOL 1999N00163 POC Sherry Smallwood, Contract Specialist, (770)
488-2699 This is a re-submission of a procurement action that was
publicized in the May 25, 1999 issue of the Commerce Business Daily.
The action was originally publicized with an incorrect title, which was
corrected in the May 27, 1999 issue of the Commerce Business Daily. To
avoid confusion among potential offerors, the action is hereby
re-publicized in it's entirety with the correct title. The Centers for
Disease Control and Prevention (CDC) intends to award a multiple-award
contract for the purpose of augmenting research activities of clinical
sites currently implementing the FDA-approved HIV vaccine trial
protocol VAX 004 (BB-IND 7426), "A Phase III Trial to Determine the
Efficacy of Bivalent AIDSVAX B/B Vaccine in Adults at Risk of Sexually
Transmitted HIV-1 Infection in North America". The Centers for Disease
Control and Prevention (CDC) is interested in (1) obtaining the
research data generated from the VAX 004 trial, and (2) conducting
additional "sub-studies" (using the patients enrolled and data
generated from the VAX 004 trial) to focus on other VAX 004
trial-related epidemiologic, laboratory, and social-behavioral
research. The resultant contractors shall be required to continue
implementing the ongoing VAX 004 trial activities as per the current
FDA approved operational guidelines to determine the protective
efficacy of AIDSVAX, and to confirm its safety and immunogenicity.
Furthermore, in the process of carrying out the VAX 004 trial, the
contractors will be required to develop additional trial-related
sub-study protocols for research which may include epidemiologic and
laboratory studies of HIV incidence and genetic characterization of
incident HIV infections, social-behavioral research on risk factors for
infection, risk behavior change associated with trial participation,
social harm and discrimination, and participant/site/community factors
related to the successful implementation of HIV vaccine efficacy
trials. These additional studies will be implemented concurrently and
become integrated into trial site activities supporting the VAX 004
trial implementation. The total target enrollment for activities under
the resultant contracts will be 1000 enrollees (all contract study
sites combined), and may include additional enrollees outside of the
trial population for comparative sub-studies. The awarded contracts
shall be of 4 years duration. Only written requests for copies of the
solicitation will be honored. Written requests may be submitted to the
Contract Specialist by fax at 770-488-2671, or by e-mail at
svs9@cdc.gov. Telephone requests will not be accepted. The date
specified for receipt of offers will be approximately 30 days after the
solicitation issue date. The solicitation issue date will be on or
about June 11, 1999. Posted 05/31/99 (I-SN337350). (0151) Loren Data Corp. http://www.ld.com (SYN# 0003 19990603\A-0003.SOL)
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