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Gates Package, p.590 · gates:exh:00202

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VaccinesGates Foundation involvement
facilitating global polio eradication and maintaining a polio-free world after eradication. The PRS emphasizes new vaccination strategies and the development of new vaccines including monovalent ones to tailor control of transmission in specific outbreaks. The PAI concentrates on the development of effective antivirals to facilitate quick control of outbreaks and to treat persistent shedders who are often immune-compromised and unable to respond to a vaccine. o Malaria - NIAID and the BMGF have both supported development of malaria vaccines for many years. Interactions between program staff at both institutions are frequent, and include: ▪ Representation of both organizations 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). Along with other members of the Malaria Vaccine Funders Group, NIAID and BMGF Staff recently contributed to the Update of the Malaria Vaccine Technology Roadmap, to be released in November, 2014. ▪ Representation of both organizations on the PfSPZ Multilateral Integration Team for development of a whole sporozoite vaccine against falciparum malaria by Sanaria. ▪ Frequent interactions between NIAID Program Staff and Staff at the PATH MVI, a principal implementer of BMGF-supported malaria vaccine R&D. ▪ NIAID and the BMGF coordinate research activities on systems biology of malaria that are funded jointly by the two organizations. ▪ NIAID supports genomic and immunologic analysis of clinical samples from the RTS,S Phase 3 trial that has been supported by BMGF through PATH MVI. ▪ Collaboration in a joint Phase 1/2 Prime-Boost study of an Adenovirus Serotype 35based 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. o Neglected Tropical Diseases ▪ NIAID and the BMGF jointly convened a meeting on "Schistosomiasis Elimination Strategies and the Potential Role of a Vaccine in Achieving Global Health Goals." A meeting report is currently under review at the American Journal of Tropical Medicine & Hygiene. A follow up meeting will be held in November, 2013 in Washington DC. ▪ BMGF supported a U.S. Phase I trial of a promising Leishmania vaccine candidate originally developed by the Infectious Diseases Research Institute (IDRI) with NIAID research funding. DMID/NIAID subsequently supported a second U.S.Phase I trial of the same candidate to address dosage and formulation issues. Future development plans are under discussion. ▪ NIAID supports Tropical Medicine Research Centers in endemic countries. One of these Centers, located in Muzaffarpur, India, is conducting research on transmission of visceral leishmaniasis. The BMGF is working collaboratively with NIAID Program Staff and co-funding a study to determine the role of asymptomatic infections and whether sandflies are able to transmit the disease from this reservoir.