HIV VACCINE PREPAREDNESS AND PHASE III EFFICACY TRIAL SITES NIH GUIDE, Volume 23, Number 1, January 7, 1994 SFP AVAILABLE: N01-AI-35176-JMEISTER1-94 P.T. 34 Keywords: Clinical Trial AIDS Vaccine National Institute of Allergy and Infectious Diseases Abt Associates Inc., under Contract No. N01-AI-35176 with the Vaccine Trials and Epidemiology Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), requires clinical trial sites to conduct seroepidemiologic and other studies in preparation for HIV vaccine efficacy trials and collaborate in potential, future multi-center phase III trials of HIV vaccines. Offerors must be capable of enrolling and following HIV-seronegative volunteers at increased risk of exposure to HIV in preparatory studies and subsequent efficacy trials. Contractors will recruit a cohort of at least 500 volunteers in preparatory studies, and must demonstrate a capacity to recruit 1,000 volunteers in efficacy trials, which may be undertaken in the future. Offerors must provide evidence of appropriate experience and feasible strategies for: retaining at least 90 percent of enrolled study participants during a two-year prospective study; reliably interviewing study participants regarding HIV-related risk behavior; collecting, processing, storing, and shipping of laboratory specimens; handling vaccine product that requires refrigerated storage; providing HIV pre-test and post-test counseling and referrals to relevant community services; assessing participants' attitudes about enrollment in preventive vaccine efficacy trials before and after delivery of relevant information about clinical trials and HIV vaccines; assuring compliance with regulations governing the protection of human research subjects including protection of participant confidentiality; and performing clinical assessments and documenting medical findings as required by vaccine trial protocols. Organizations submitting proposals must respond to Solicitation for Proposal (SFP) requirements for both vaccine preparedness studies (Part A) and plans for potential future phase III efficacy trials (Part B). Proposals that address only the requirements of Part A will not be considered. Plans and budgets for Part A are to be developed for a period of performance of two years. Plans and budgets for Part B are to be developed for a period of performance of five years. Abt Associates contemplates award of cost plus fixed fee subcontracts to successful offerors. Initial awards will support Part A studies only. Award of funds for Part B trials will be contingent upon the availability of promising vaccine candidates. Subcontract modifications to support Part B trials and associated budgets will be negotiated only after authorization by NIH to proceed with the implementation of vaccine efficacy trials. Technical evaluation of proposals will consider offerors' experience and approach to both components of the SFP (Part A and Part B). It is anticipated that offerors will be invited to include, as an optional component of their submission, proposals for the conduct of non-vaccine HIV prevention interventions (Part C). Results of the technical review of proposals for non-vaccine prevention interventions (Part C) will not be considered in the determination of the number and size of awards for preparedness studies and efficacy trials (Parts A and B). This is an announcement for an anticipated SFP. This notice does not commit the Government or Abt Associates Inc. to award a contract. SFP N01-AI-35176-JMEISTER1-94 will be issued on or about January 10, 1994, with a closing date for receipt of proposals tentatively set for March 10, 1994. To receive a copy of the SFP, supply Abt Associates Inc. with three self-addressed mailing labels. All inquiries must be in writing and addressed to: A. Walker Re: SFP-JMEISTER1-94 HPRA, Abt Associates Inc. 4800 Montgomery Lane, Suite 600 Bethesda, MD 20814 .
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