Gates Package — page 589

combination prevention packages, both of which include universal HIV testing and intensified provision of HIV antiretroviral therapy and care, on population-level HIV incidence. This study is being conducted in 24 communities in Zambia and South Africa. o NIAID works closely with BMGF to lead the Pox-Protein Public-Private Partnership which includes our two organizations, the HIV Vaccine Trials Network (HVTN), the U.S. Military HIV Research Program (MHRP), Sanofi-Pasteur and Novartis. The goals of the partnership are 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 to evaluate next generation pox-protein vaccine candidates for safety, immunogenicity and efficacy. NIAID and the BMGF are the primary funders of this enterprise and thus far have co-funded the efforts for HIV Env down-selection, Processes and Analytics development, Tech Transfer, and manufacture the protein components for southern Africa. Novartis will oversee the manufacturing at a CMO which has begun in September 2013. In addition, the BMGF will be working with NIAID to begin funding some of the clinical trial sites in Southern Africa for training in preparation for vaccine efficacy studies o A whole genome sequencing of 200 HIV-exposed seronegative Hemophilia subjects (David Goldstein/Duke University/CHAVI), co-funded by the BMGF and NIAID, will search for rare genetic variants that could explain reduced susceptibility to HIV infection through whole genome resequencing of 200 Hemophilia patients who were exposed to HIV in the early 80s but did not become infected. Whole genome sequencing is being performed as a follow-up to an initial GWAS analysis of about 600 such subjects that failed to reveal any common genetic variants as an explanation for reduced susceptibility to infection. • Other Diseases o Highly Pathogenic Avian Influenza (HPAI) H5N1 - Highly significant research findings published in Nature in 2012 by Dr. Yoshihiro Kawaoka were funded with grants from both NIAID and the Gates Foundation. This paper demonstrated that highly pathogenic avian influenza (HPAI) H5N1 viruses can be transmitted between mammals via respiratory droplets. This important work validated the pandemic threat that HPAI H5N1 viruses pose in nature and has informed surveillance of circulating avian influenza viruses for pandemic potential. This work has also provided basic knowledge on how animal influenza viruses gain the ability to transmit in mammalian species and will aid in the development and evaluation of countermeasures against these viruses. o Childhood Pneumonia - NIAID is supporting a clinical study on childhood pneumonia that will be tested within an existing BMGF-funded birth cohort study. The birth cohort study supported by BMGF is designed to enroll approximately 500 children who will have nasopharyngeal (NP) sampling at birth, 6 weeks of life and every 6 months thereafter for the first 2 years. The NIAID-supported activity includes a more detailed analysis in a subset of approximately 300 children, using sequence-, culture- and specific PCR-based approaches to define the composition and dynamics of the infant NP microbiome from birth to two years of age and to determine the association between the NP microbiome and pneumonia or wheezing in African infants. o Global Polio Eradication - Both DMID and BMGF participate and interact as members of the WHO Polio Research Committee (PRS) and the Polio Antiviral Initiative (PAI), which focus on