Gates Package — page 152

NATIONAL INSTITUTES OF HEALTH (NIH) -- BILL & MELINDA GATES FOUNDATION (BMGF) ACTIVE PARTNERSHIPS IN GLOBAL HEALTH (no current exchange of funds) P5 (the Pox-Protein Public-Private Partnership) -- P5 is an AIDS vaccine development initiative involving NIAID, BMGF, the HIV Vaccine Trials Network (HVTN), the U.S. Military HIV Research Program (MHRP), Sanofi-Pasteur and Novartis. It seeks to advance clinical development of pox vector, Env protein boost vaccine concepts in order to extend and confirm the RV 144 efficacy results in high risk populations, advance the candidates toward licensure, and evaluate next generation pox-protein vaccine candidates for safety, immunogenicity and efficacy. NIAID and the BMGEF are the primary funders of this enterprise and have so far co-funded efforts for HIV Env down-selection, processes and analytics development, tech transfer, and manufacture of the protein components for southern Africa. Novartis will oversee manufacturing at a CMO beginning in September 2013. BMGF, with NIAID, will begin soon to fund clinical trial sites in Southern Africa for training in preparation for vaccine efficacy studies. Malaria Vaccine Development and Evaluation - NIAID and BMGF have supported and coordinated efforts to develop malaria vaccines for many years. Both are engaged in the Malaria Vaccine Funders Group, along with USAID, the European Commission, the Wellcome Trust, the European Vaccine Initiative, the European-Developing Country Clinical Trials Partnership (EDCTP), and the PATH Malaria Vaccine Initiative (MVI). The Malaria Vaccine Funders Group, with active NIAID and BMGF scientific engagement, will release the Update of the Malaria Vaccine Technology Roadmap in November, 2014. Both NIAID and BMGF are represented on the PfSPZ Multilateral Integration Team for development of a whole sporozoite vaccine against falciparum malaria by Sanaria. NIAID scientists serve as advisors for several BMGF-supported vaccine discovery projects implemented by the PATH Malaria Vaccine Initiative. tVI. Recently the organizations collaborated in a joint Phase 1/2 Prime-Boost study of an Adenovirus Serotype 35-based malaria vaccine (Ad35.CS) followed by RTS,S. NIAID supported the preclinical and clinical development of Ad35.CS, provided clinical trial material for the study, and participated on the protocol team that designed and oversaw the study. "Decade of Vaccines" Collaboration (DoVC) -- This initiative, launched in 2010, engaged multiple public and private sector vaccine-focused organizations under WHO, BMGF and NIAID leadership. It produced the Global Vaccine Action Plan (GVAP), which was endorsed by the World Health Assembly in 2012. To continue the work launched by the DoVC, representatives of BMGF, NIAID, and WHO signed a Memorandum of Understanding (MOU) in March, 2013 to extend collaborative vaccine R&D efforts and establish the Global Vaccine and Immunization Research Forum (GVIRF). This forum will track R&D progress as compared to the goals and strategic objectives of the Global Vaccine Action Plan. It will also help identify and respond to R&D opportunities. The first GVIRF will take place 4-6 March 2014 in Bethesda MD, and approximately every 18 months thereafter.