A -- Global HIV/AIDS Vaccine Enterprise Secretariat

The Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), intends to award a sole source contract to the Global HIV/AIDS Vaccine Enterprise Secretariat for a base period of two years and subsequent option periods. Option 1 will consist of two years and Option 3 will consist of three years. The total estimated cost of this project will not exceed $7M. This award will be made under Authority of 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(b)(1)(i), Unique Capabilities. The contractor will provide services to the GHAVE Consortium: coordinate efforts at a global level, facilitate use of common tools and technologies, and help ensure access to optimized resources. These goals will be facilitated through Enterprise Secretariat whose core functions are divided in to 3 main areas of: (A) Scientific stewardship (B) Communication and Knowledge Management and (C) Policy Analysis and Development. Scientific stewardship and communication management will be the two main areas of focus in the statement of work. Since HIV was identified more than two decades ago 42 million people have been infected worldwide. Approximately 14,000 people are newly infected with HIV every day and if the current trend continues, it is projected that 45 million more people will be infected by 2010. The impact of AIDS on several developing nations is enormous. There is a great loss of productivity and profitability due to decline in skilled workforce in those developing countries as well as increase in the cost of morbidity and mortality. Along with the burden of creating a generation of orphans, AIDS has had world-wide impact on economy, political stability and social structure of those affected countries. Developing a safe and efficacious HIV vaccine that prevents HIV infection and/or transmission of HIV to others would be an enormously valuable tool for global control of the AIDS pandemic. Despite scientists considerable efforts to develop a safe and effective vaccine, progress has been slow mainly due to scientific challenges as well as challenges in conducting clinical trials in the developing countries, which include lack of health care system infrastructure, insufficient financial and human resources. Despite considerable efforts on the part of academia, government and private sector scientists, many of the fundamental scientific obstacles to HIV vaccine development remain. The motivation behind the creation of the Global HIV/AIDS Vaccine Enterprise (GHAVE) was to accelerate the development of a preventive HIV Vaccine through collaborative efforts across institutions and disciplines within private industry, academia, government agencies, and non-governmental organizations in developed and developing countries to tackle these persisting obstacles. Originally proposed by 24 leaders in the international HIV vaccine community, in an article published in June 2003 (Klausner RD, et al, Science 300:2036-2039, 2003), Enterprise was created to accomplish the following goals: (A) establish greater collaboration (B) increase resources, and (C) develop and implement a shared scientific strategic plan (SSP). GHAVE is a virtual consortium of independent organizations committed to accelerating the development of a preventive vaccine for HIV/AIDS. GHAVE will accomplish its mission by implementing shared strategic scientific plan and engaging the broader international community, including the G8 leaders, to support HIV vaccine research and make it an integral part of the global response to HIV/AIDS (Science 304: 1701-1856, 2004). The GHAVE Scientific Strategic Plan, the centerpiece of the Enterprise, encompasses 6 key areas of (1) Vaccine Discovery, (2) Laboratory Standardization, (3) Product Development and Manufacturing, (4) Clinical Trials Capacity, (5) Regulatory Considerations, and (6) Intellectual Property Issues. The GHAVE Secretariat has gained international consensus and possesses the endorsement of the GHAVE Consortium which is made up of a multitude of stakeholders from the international community committed to the development of an HIV/AIDS Vaccine. This endorsement lends credibility to the GHAVE Secretariat's vital role in developing and updating a scientific strategic plan for the international community in order to maximize the benefits of investments made by the international community into the research and development of a vaccine. No entity, other than the GHAVE Secretariat, has the unique capabilities that have been developed by virtue of their filling a recognized void. The GHAVE Secretariat has received a grant from a private organization and it has been assured that funding will continue from that source in the future. Without the direct support of NIAID and other global partners, the grant support will not be sufficient to sustain this vital resource. In addition, the NIAID funding would have to be at least doubled to reap the same benefit for the DAIDS/Vaccine and Prevention Research Program, and would therefore result in not only a duplication of costs but the overall costs would be greater. Finally, as the success of GHAVE requires an internationally organized and endorsed effort, the NIAID/DAIDS, as a US Government Agency, could not by itself formulate a research agenda that would have such broad international scope and acceptance. Therefore, no other service will satisfy Agency requirements. If there are responsible sources who feel that they are able to perform the requirement, they must respond by submitting their interest and a capability statement demonstrating their ability to assume the work without unnecessary delay and duplication of costs and effort. See Government-Wide Numbered Notes 22 and 26.