Centers for Disease Control and Prevention (CDC), Procurement and Grants Office, SECTION II, 2920 Brandywine Road, Room 3208, Atlanta, GA 30341-4146

A -- TUBERCULOSIS TRIALS CONSORTIUM (TBTC) SOL 1999N00163 POC Sherry Smallwood, Contract Specialist, (770) 488-2699 The Centers for Disease Control and Prevention (CDC) intends to award a multiple-award contract (approximately 4 -- 6 awards) 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. Onlywritten 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 05/21/99 (I-SN334263). (0141)

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