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Developing Vaccines for Neglected Diseases

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Developing Vaccines for Neglected Diseases Developing Vaccines for Neglected Diseases Vaccine Technologies II Albufeira, Portugal June 5th, 2008 Douglas Holtzman, Ph.D., M.P.H. Senior Program Officer, Global Health Program Bill & Melinda Gates Foundation 1 Three Programs, One Goal: Equity US Program » High school education » Public library internet access Global Development » Financial services for the poor (e.g. microfinance) » Agricultural productivity and markets Global Health 2 Perspective on Global Health The vision: To ensure that a child born in the developing world has the same chance for good health as a child born in the developed world The goal: Build on advances in science and technology to save lives, improve health, and reduce disease in the developing world 3 Prioritization Burden of disease Inequity of burden Lack of attention Possibility for impact 4 Disease Areas HIV (vaccines, microbicides, treatment, prevention, education) TB (drugs, vaccines, diagnostics) Malaria (drugs, vaccines, vector control, diagnostics, scale-up) Pneumonia Diarrhea Nutrition Maternal Health Discover, develop and deliver Kinetoplastids innovative solutions Helminths HPV Dengue/Japanese Encephalitis Polio 5 Partnerships Global Alliance for Vaccines and Immunization (GAVI) Global Fund for AIDS, TB and Malaria HIV Vaccine Enterprise Medicines for Malaria Venture (MMV) Malaria Vaccine Initiative (MVI) MACEPA PATH Vaccine Solutions (PVS) Aeras (TB Vaccines) Global Alliance for TB Drug Development (GATB) ACHAP Grand Challenges in Global Health IVI/PDVI Etc…. 6 PDP-Private Sector R&D Deals: Win/Win Proposition? PDP provides • Financing PDP gets • LDC trial sites PDP • IP or low price in • Access/distribution plans LDCs Drugs • Market analysis • Rapid access and • Global health expertise • Recognition as Vaccines Joint catalyst for R&D Neglected Industry provides Industry gets Diseases • Technology candidate • IP and pricing for rich • Related know-How: countries -process engineering • Essential financing for -GCP, GLP, QC/QA small biotech firms -scale up and manufacturing Private • New technology -project management platforms with other • Financing commercial uses • Manufacturing capacity • Good will Source: Adopted from MMV; Rockefeller Foundation 7 THE GOAL » To encourage scientific risk-taking on creative, unorthodox ideas for global health THE INITIATIVE » US$100 million funding initiative over 5 years » Will fund hundreds of projects based on two-page submission – next round opens September 15th » Initial grants of $100,000 with potential for additional funding (~$1M) if promising » Opportunity for direct engagement with the private sector » Sign up at www.gcgh.org/explorations/ for email updates 8 Pre-clinical research toward a vaccine against African trypanosomiasis 9 Objectives To identify specific candidate antigens that generate protective immune responses against Trypanosoma brucei in cattle To further test plant-based transient gene expression systems for production of vaccines appropriate for developing countries 10 African Trypanosomiasis Parasitic disease limited to tropical Africa 60M people at risk; affects all ages ~40-60K annual deaths – most die unreported in the bush (~300-500K?) Resurgence of disease Billions of $ of lost agricultural productivity World’s greatest disparity disease 11 Distribution of sleeping sickness in sub- Saharan Africa, 1999 WHO http://www.who.int/csr/resources/publications/CSR_ISR_2000_1tryps/en/index.html 12 Cycle of disease Infected Systemic infection CNS Infection fly bite Stage I Stage II Death 13 Antigenic shifts lead to…. VSG1 VSG2 VSGx Parasite # Time ….waves of parasitaemia VSG = variable surface glycoprotein 14 Proof of Principle 15 Trypansome tubulin-rich regions as “Achilles Heel” 16 Technology: Alfalfa Mosaic Virus P1 P2 P3 CP CP Viral gene structure Electron F Micrograph P C K D P G A T I R L S Particle-based Y S peptide delivery M system Antigenic peptide Slide provided by Dr. Yusibov, Fraunhofer CMB 17 Mouse Experiments Show Protection Experiment #1 Experiment #2 Antigen used Protection rate (%) Vaccine candidate Protection rate (%) Atub 1-4 60 ALMV 13 Atub 5-8 70 Atub 1-4 40 Btub 1-4 90 Atub 5-8 40 Btub 5-8 90 Btub 1-4 53 AlMV 0 Btub 5-8 100 Adjuvant 0 Btub 2 100 Btub 3 0 Btub 5 100 Btub 11 40 Tubulin (native) 27 Adjuvant 13 Atub (rec. full length) 27 Btub (rec. full length) 33 Negative control 0 Slide provided by Dr. Yusibov, Fraunhofer CMB 18 Parasitemia in cattle post challenge with T. brucei brucei Days post challenge Groups cow -4 7 10 12 14 17 40 45 AlMV 1 - - - + + + + + 2 - + + + + + + + 3 - + + + + + + + 4 - + + + + + + + Btub2+ Btub5 1 - - - - - + + + 2 - - - - - + + + 3 - - - - - + + + 4 - - - - - + + + Slide provided by Dr. Yusibov, Fraunhofer CMB 19 Survival of cattle post challenge with T. brucei brucei 20 Summary Pre-clinical program for trypanosomiasis vaccine underway - if successful, could provide a solution for an important agricultural and development issue Fraunhofer’s transient, plant-based expression system could have utility for inexpensive production of highly immunogenic recombinant vaccines for developing world 21 Partners Dr. Vidadi Yusibov, Director of the Fraunhofer Center for Molecular Biotechnology, USA Dr. Roger Pritchard, Professor, McGill University, Canada Dr. George Lubega, Professor, Makerere University, Uganda 22.
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