Gates Package — page 592

The meeting was ▪ On April 18019, 2012, Drs. Fred Cassels and Melody Mills invited to attend and participate in the conference on "H. pylori in Children in Developing Countries." The meeting was supported by BMGF. OVERVIEW OF COOPERATIVE PROGRAMS • Centralized Envelope Comparative Immunogenicity Phase I Study (CECI) Goal: Understand how best to design T-cell immunogens in order to develop a vaccine that addresses the broad genetic diversity of HIV-1 Funding: $4.4M (2009-2014) CECI is a partnership with BMGF, NIAID, IPPOX Foundation, and several academic institutions. The project will test, in a phase 1 clinical trial, a vaccine regimen composed of a DNA prime-NYVac Boost containing a new set of artificial computer-designed HIV genes that should provoke the immune system to respond to a wide variety of HIV strains. The BMGF grant will cost-share vaccine production with NIAID's Division of AIDS and IPPOX Foundation, while NIAID will support the clinical trial. Scientific leadership of CECI is provided though Duke University's Human Vaccine Institute. Manufacturing of the vaccine products has been completed, an IND filed, and the FDA has allowed the clinical trial to initiate (HVTN098). The trial is set to begin enrollment in 3Q2013. • cGMP Production of a Trimeric HIV gp145 Clade C Env Protein Goal: To manufacture a clade C HIV Env protein as a clinical research reagent for clinical research studies Funding: 2.9M (2012-2016) This grant is to provide additional support to the ongoing NIAID manufacturing efforts to provide an HIV Env protein (collaboration with the MHRP) to the HIV vaccine community for testing in clinical research studies such as adjuvant comparison studies, boosting vaccines, etc. • Identification of high-quality HITs for Tuberculosis (HIT-TB) Goal: Produce high-quality chemical hit series with defined, tractable targets as drug leads for tuberculosis Funding: $7.3M (2010-2013) Scientific leadership of the project is based at the Tuberculosis Research Section of NIAID • Comprehensive T-Cell Vaccine Immune Monitoring (CTC-VIMC) Goal: Establish standardized T-cell assays and capacity to support HIV vaccine testing Funding: $50M (2006-2016) (CTC-VIMC) is an integral part of the BMGF-sponsored Collaboration for AIDS Vaccine Discovery, which is a component of the larger Global HIV/AIDS Vaccine Enterprise. CTC-VIMC aims to ensure broad access to assays and technologies that will enable valid comparisons of the cellular immune responses induced by new candidate HIV/AIDS vaccines as they undergo preclinical research and