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Recent Zoonotic and Vector-Borne Viral Threats NIAID Vaccine

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Recent Zoonotic and Vector-Borne Viral Threats NIAID Vaccine 4/1/2020 PROTOTYPE PATHOGEN APPROACH TO PANDEMIC PREPAREDNESS HIV→PNEUMOVIRUS→PARAMYXOVIRUS→CORONAVIRUS ADVAC Alumni 2 April 2020 Barney S. Graham, MD, PhD Deputy Director Vaccine Research Center, NIAID, NIH 1 Recent Zoonotic and Vector-borne Viral Threats • Hanta virus • Nipah/Hendra • West Nile virus • SARS • Influenza • Chikungunya • Ebola • MERS • Zika • EV‐D68 • SARS‐CoV‐2 2 NIAID Vaccine Research Center Basic Research Process Development Nucleic acid Vectors VLPs • AIDS/HIV • Influenza Proteins and cGMP Manufacturing nanoparticles • Ebola/Marburg • RSV • Malaria Monoclonal antibodies • Tuberculosis • EID GLP Analysis • West Nile virus, Zika • Chikungunya • W/E/V equine encephalitis viruses • MERS‐CoV, SARS, and other CoV • Nipah and other paramyxoviruses • EV‐D68 and other picornaviruses Clinical Trials • Smallpox 3 1 4/1/2020 Public health burden of re-emerging & emerging viruses Traditional Approaches • Licensed vaccines/antibiotics Vaccine • Passive surveillance Challenges • Contact tracing • Quarantine • Vaccines for unmet needs • Emerging viruses • Improving licensed vaccines 4 4 New Technologies are Transforming Vaccinology • Structure-based vaccine design Structural analysis of antigenic sites on viral • Single-cell sorting, sequencing, and bioinformatics surface glycoproteins – Rapid isolation of human mAbs Isolation of human monoclonal – Definition of antibody lineages antibodies from single B cells – Analysis of immune responses • Protein engineering of self-assembling nanoparticles • Rapid DNA synthesis • Recombinant DNA and genetic engineering technology Epitope-specific phenotyping – Rapid cell line development Sequencing for viral diversity and escape mutations – Animal model development • Nucleic acid and vector-based delivery of vaccine antigen Sequencing B cells to define clonal lineages; TCR & BCR-specific transcriptome 5 5 New Technologies Facilitate an Engineering Approach Vaccine New Challenges Technologies • Vaccines for • Structural biology unmet needs • Protein engineering • Emerging viruses • Single cell sorting and analysis • Improving • High throughput sequencing licensed vaccines • Rapid isolation of human mAbs • Antibody lineage analysis • Rapid diagnostic tools • Systems biology 6 6 2 4/1/2020 Gene Synthesis and Platform Technologies Historical knowledge about virus Isolation of virus and extraction …ATGCGACT… biology and structure. and sequencing of genome Understanding antigenic targets Digital transfer of and basis for immunity information Surveillance and Discovery Design and Synthesis Virus‐infected person from Synthetic Vaccinology Synthesis of key genes encoding new outbreak vaccine antigens and other reagents Graham & Sullivan. Nature Immunology 2018 7 7 Platform Technologies Shorten Manufacturing Timelines 100 days → ~50 days Graham, Mascola, Fauci. Novel Vaccine Technologies: Essential Components of an Adequate Response to Emerging Viral Diseases JAMA2018 8 8 9 3 4/1/2020 10 11 12 4 4/1/2020 Structure-guided Stabilization of HKU1 CoV Spike V1060P L1061P 13 2-P Mutation Stabilizes MERS and SARS CoV S Improved expression, prefusion structure, immunogenicity 50‐fold greater expression than WT MERS S‐2P ‐ V1060P & L1061P MERS S‐2P stabilizes prefusion trimers by EM Prefusion S Postfusion S Pallesen, J., Wang, N., Corbett, K., … Graham BS, Ward A, McLellan et. al. PNAS 2017 14 2P mutations effectively stabilize multiple CoV prefusion S Pallesen, J.*, Wang, N.*, Corbett, K.*, et. al. PNAS. 2017. 15 5 4/1/2020 2P mutations effectively stabilize multiple CoV prefusion S Potentially Endemic Human CoVs Porcine CoV Emerging CoV EM Reconstruction by Robert Kirchdoerfer (Ward lab | Scripps) 16 Immunogenicity of MERS S-2P in Mice Pallesen, J., Wang, N., Corbett, K., et. al. PNAS 2017 | EM by Yaroslav Tsybovsky 17 17 Stabilized MERS Spike-2P Protects hDPP4 Knock-in Mice from Lethal Challenge Adam Cockrell, Ralph Baric, Kizzmekia Corbett 18 18 6 4/1/2020 MERS S-2P mRNA elicits better neutralizing antibodies than MERS S-WT mRNA Dose Titration 0.016 g Immunogen Dose MERS S-2P vs. MERS S WT mRNA **** 106 105 105 4 **** 10 Titer Titer 50 4 50 10 103 103 S WT 102 102 S-2P Reciprocal IC Reciprocal IC 1 1 10 10 S WT S-2P 0.01 0.1 1 Immunogen Dose (µg) Immunonogen Group Dr. Kizzmekia Corbett in collaboration with Moderna Therapeutics 19 Summary • S from multiple CoV strains can be stabilized in the prefusion conformation using homologous 2P mutations • Stabilized prefusion S trimers are more immunogenic and protective than WT trimers or monomeric subunits • May be a general solution for beta‐CoV vaccine antigen design 20 20 21 7 4/1/2020 CORONAVIRUS BIOLOGY AND NOMENCLATURE corona = crown or circle of light Spike Protein Wrapp D, Wang N, Corbett KS, Goldsmith JA, Hsieh CL, Abiona O, Graham BS, McLellan JS. Cryo‐EM structure of the 2019‐nCoV spike in the prefusion conformation. Science. 2020 Feb 19:eabb2507. doi: 10.1126/science.abb2507. 22 Vaccine Target: Coronavirus Spike Protein • Coronavirus spike protein is on the viral surface and mediates attachment to cells to start the infection process • Ideal vaccines target coronavirus spikes in order to block viral infection Spike Protein Human ACE2 Receptor Coronavirus CellsCells inin HumanHuman BodyBody 23 Vaccine Target: Coronavirus Spike Protein • Coronavirus spike protein attaches to ACE2 protein to start infection Coronavirus CellsCells inin HumanHuman BodyBody 24 8 4/1/2020 Vaccine Target: Coronavirus Spike Protein • Vaccine‐induced antibodies will block the interaction and function of CoV spike protein Antibodies Coronavirus CellsCells inin HumanHuman BodyBody 25 COVID-19 VACCINE DEVELOPMENT 2013-2019 2020 2021 SARS-CoV-2 Outbreak 2013-2019 Jan 6, 2020 Jan 11, 2020 Jan 14, 2020 Jan 31, 2020 Feb 4, 2020 Feb 10, 2020 Feb 19, 2020 Feb 21, 2020 March 16, 2020 Spike Extensive work Wuhan 2019-nCoV Moderna VRC makes VRC UT-Austin Moderna Phase 1 Clinical structure on MERS and outbreak may constructs receives nCoV spike vaccinates solves spike ships vaccine trial Starts published in other CoV be CoV ordered sequence for protein mice structure to DMID Science GMP production Dec 31, 2019 Jan 10, 2020 Jan 13, 2020 Jan 23, 2020 Feb 1, 2020 Feb 7, 2020 Feb 18, 2020 Feb 20, 2020 Mar 2, 2020 1st report of 2019-nCoV VRC decides DMID First nCoV Moderna Immunogenicity DMID FDA safe-to- respiratory virus sequences on vaccine initiates spike ELISA vials vaccine confirmed in submits IND proceed outbreak in published sequence clinical and for cross- mice Wuhan, China with Moderna regulatory reactivity process 3 days 38 days 24 days Previous fastest timeline 90 days 100 days ZIKV DNA vaccine 26 COVID-19 Vaccine Consortium NIAID OD: NIAID VRC USG organization Vaccine design Vanderbilt Communications Assay development Live virus PRNT Diplomatic Relations Preclinical evaluation Human immunology UW IPD Pathogenesis NIAID DMID: Nanoparticle display IND VTEU clinical trial sites Advanced development UT Austin Spike structure NIAID DIR RML animal NHP model UNC: Industry Molecular clone CDC Non‐profit and mouse model COVID‐19 Virus isolation Vaccine Diagnostics Government Sample sharing Public health organizations Development WHO Academia Multiple Advisory and WG committees and US Dept of State coordination NIAID office of Global Affairs Negotiations with WHO and China CEPI DOD WRAIR: Funding Prior MERS study and collaborators Abcellera FDA CBER: mAb discovery Regulatory oversight and BARDA/ASPR: advice Moderna Development support, USG GMP mRNA organizational leadership 27 9 4/1/2020 Structure of Prefusion RSV F Glycoprotein Prefusion Postfusion 28 28 Generalized Application to Other Fusion Proteins Graham, Gilman, McLellan, Annual Review of Medicine 2019 29 Summary • New technologies are transforming vaccinology providing solutions for long-standing problems and emerging viral diseases • Combining atomic level antigen design with computationally designed nanoparticles and platform manufacturing approaches provides a modular, engineering approach to achieve generalizable solutions for vaccine antigen design • The advent of precision vaccinology with rapid platform manufacturing makes a prototype pathogen approach for pandemic preparedness feasible 30 30 10 4/1/2020 NIAID Vaccine Research Center Viral Pathogenesis Laboratory VPL Tracy Ruckwardt Masaru Kanekiyo Kaitlyn Morabito Michelle Crank Kizzmekia Corbett Seyhan Boyoglu‐Barnum Lauren Chang Rebecca Gillespie Emily Phung Adrian Creanga Man Chen Syed Moin Deepika Nair Julia Lederhofer Olubukola Abiona Geoffrey Hutchinson Azad Kumar Brian Fisher Alex Derrien‐Coleman Cynthia Ziwawo Anthony Dipiazza Osnat Rosen Rebecca Loomis Karin Bok Erez Bar Haim Saavan Chintalacheruvu Monique Young LaTanya Chapman VRC NIAID Julie Ledgerwood & Clinical Trial Program John Mascola Mario Roederer Anthony Fauci Adrian McDermott & Vaccine Immunology Program Richard Koup Daniel Douek Hilary Marston Diane Scorpio & Animal Care Program Sarah Andrews Robert Seder Cristina Cassetti Jason Gall & Vaccine Production Program Peter Kwong Nancy Sullivan Audray Harris David Lindsay & Vaccine Clinical Material Program Jeffrey Boyington Judy Stein/Will Adams Theodore Pierson Kevin Carlton & Project Management Abe Mittelman Marybeth Daucher 31 Acknowledgements VRC Immunology Cores Kathy Foulds Amy Noe Dillon Flebbe Nadesh Nji Shing-Fen Kao Valerie Ficca Madhu Prabhakaran UT Austin Scripps Neil King Jason McLellan Andrew Ward Joshua Brand David Baker David Ambrozak Morgan Gilman Jesper Pallesen Daniel Ellis Funding:DB, NPK Brooke Fiala Nianshuang Wang Robert Kirchdoerfer
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