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TESTIMONY Peter J. Hotez MD, Phd President, Sabin Vaccine Institute
TESTIMONY Peter J. Hotez MD, PhD President, Sabin Vaccine Institute “The Growing Threat of Cholera and Other Diseases in the Middle East” Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations Committee on Foreign Affairs United States House of Representatives March 2, 2016 Mr. Chairman and Members of the Subcommittee, thank you for the opportunity to speak with you today. I am Peter Hotez, a biomedical scientist and pediatrician. I am the dean of the National School of Tropical Medicine at Baylor College of Medicine and also the Texas Children’s Hospital Endowed Chair in Tropical Pediatrics based at the Texas Medical Center in Houston. I am also past president of the American Society of Tropical Medicine and Hygiene, and currently serve as President of the Sabin Vaccine Institute, a non-profit which develops vaccines for neglected tropical diseases (NTDs) through a product development partnership (PDP) model. This year I am also serving as US Science Envoy for the State Department and White House Office of Science and Technology Policy focusing on the urgency to develop vaccines for diseases that are emerging in the Middle East and North Africa due to the breakdowns in health systems in the ISIS occupied conflict zones in Syria, Iraq, Libya, and also Yemen. In my submitted written testimony I highlighted some of the successes in US global health policy, many of which can be attributed to the hard work of this Subcommittee working hand in glove with two presidential administrations since 2000. I cite evidence from the Global Burden of Disease Study (GBD) that brings together hundreds of scientists - I am also a part of this - who are measuring the impact of large scale global health programs. -
Study Protocol
Protocol Number: VXA-G11-201.1 ________________________________________________________________________________ Clinical Study Protocol Protocol Title: Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model Protocol Number: VXA-G11-201.1 IND Sponsor: WCCT Global 3545 Howard Way, Costa Mesa, CA 92626 Maria Apkarian Vice President, Early Clinical Development Email: [email protected] Phone: 714-252-0700; ext: 1019 Funding Sponsor: Vaxart, Inc. Funding Sponsor POC: David N. Taylor, MD Chief Medical Officer Vaxart, Inc. 400 Oyster Point Blvd., Suite 222 South San Francisco, CA 94080 Email: [email protected] Mobile phone: 919-349-6109 Protocol Version Number: 1.1 Amendment 1 Date: 21 September 2018 Confidentiality Statement This document is confidential and is to be distributed for review only to investigators, potential investigators, consultants, study staff, and applicable independent ethics committees or institutional review boards. The contents of this document shall not be disclosed to others without written authorization from Vaxart (or others, as applicable), unless it is necessary to obtain informed consent from potential study subjects. SIGNATURE PAGE/STATEMENT OF COMPLIANCE Version 1.1 Confidential Page 1 of 50 Date: 21Sept 2018 Protocol Number: VXA-G11-201.1 ________________________________________________________________________________ Protocol Title: Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model Protocol Number: VXA-G11-201.1 Vaxart, Inc. ______________________________ ________________ David Taylor Date Chief Medical Officer The trial will be conducted in accordance with the International Conference on Harmonisation (ICH) E6 and the Code of Federal Regulations on the Protection of Human Subjects (45 CFR Part 46). -
Sabin in the News Recent Scientific Articles Sabin Vaccine Institute
Home About Us News & Resources Support Sabin Sabin in the News October 2011 The Sabin Report | Volume 13 Issue 2 New York Times article featuring Dr. Peter Hotez's new study on increased Sabin Vaccine Institute Establishes a Houston prevalence of NTDs in Europe. Office Drs. Ciro de Quadros and In September 2011, the Zulfiqar Bhutta highlight Sabin Vaccine Institute the dire need for a dengue established offices in vaccine in an opinion Houston, Texas in the piece for GlobalPost. heart of the city's Texas Medical Center (TMC). The In an interview on Voice of new facilities will house the America Dr. Peter Hotez Sabin Vaccine Institute & focused on NTDs in Sub- Texas Children's Hospital Saharan Africa. Center for Vaccine Development, which will be An article by Dr. Neeraj operated in partnership Mistry was featured in a with Baylor College of special supplemental Medicine Department of section of the USA today, Pediatrics. Sabin Dr. Hotez and team at Sabin's new Houston facility titled "Neglected Diseases President, Dr. Peter J. in Developing Nations". Hotez will direct the new center. In an op-ed for the Houston Chronicle, Dr. The new space includes offices and laboratories through which the Peter Hotez writes about Sabin Vaccine Institute Product Development Partnership (PDP) will the establishment of the advance and strengthen its collaborative work in the field of vaccine new School of Tropical biotechnology. The change is the result of a year-long plan to expand Medicine at Baylor College the scope and depth of the Sabin PDP's partnership and to enhance of Medicine. -
Placebos, Randomization and Financial Incentives
1 Placebos, randomization, and financial incentives – oh my! Balancing ethical considerations in clinical research Stephanie Kraft, JD and Kathryn Porter, JD, MPH ITHS Bioethics Core Treuman Katz Center for Pediatric Bioethics Seattle Children’s Research Institute Learning Objectives 1• Describe eight benchmarks for ethical clinical research 2 Discuss how empirical data illustrates limitations of ethics regulations of randomization 3 Identify elements of a proposed research study that warrant ethical deliberation Outline 1 Introduction to a framework for ethical clinical research 2 Case studies: what to do when benchmarks conflict 3 Group discussion and practice applying the framework Why research ethics? Please vote: Do you consider yourself an ethically responsible researcher? Why research ethics? “Isn’t ethics for people who have bad motivations?” • Not just about preventing egregious violations - no such thing as the “ethics police” • Also offers guidance, identifies potential challenges Why research ethics? Please vote: Have you ever faced an ethical challenge in your research that was outside the scope of the IRB? Why research ethics? “Aren’t there regulations for that?” • Research ethics analysis helps flesh out responsibilities above the regulatory floor Why research ethics? Please vote: Have you ever raised an ethics issue to a colleague or PI? Why research ethics? “Is it really my job to worry about ethics?” • Yes! • Ethics analysis is important for all research team members • Framework can empower researchers to identify and -
Human Challenge Trials for Vaccine Development: Regulatory Considerations
POST ECBS Version ENGLISH ONLY EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION Geneva, 17 to 21 October 2016 Human Challenge Trials for Vaccine Development: regulatory considerations © World Health Organization 2016 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. -
A Toddler PCV Booster Dose Following 3 Infancy Priming Doses Increases
Vaccine 36 (2018) 2774–2782 Contents lists available at ScienceDirect Vaccine journal homepage: www.elsevier.com/locate/vaccine A toddler PCV booster dose following 3 infancy priming doses increases circulating serotype-specific IGG levels but does not increase protection against carriage ⇑ Ron Dagan a, , Shalom Ben-Shimol a,b, Birgit Simell c, David Greenberg a,b, Nurith Porat a,b, Helena Käyhty d, Noga Givon-Lavi a,b a The Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel b The Pediatric Infectious Disease Unit, Soroka University Medical Center, Beer-Sheva, Israel c Institute for Molecular Medicine Finland (FIMM), University of Helsinki, Helsinki, Finland d Department of Vaccination and Immune Protection, National Institute for Health and Welfare (THL), Helsinki, Finland article info abstract Article history: Background: We compared PCV7 serological response and protection against carriage in infants receiving Received 7 January 2018 3 doses (2, 4, 6 months; 3+0 schedule) to those receiving a booster (12 months; 3+1). Received in revised form 30 March 2018 Methods: A prospective, randomized controlled study, conducted between 2005 and 2008, before PCVs Accepted 3 April 2018 were implemented in Israel. Healthy infants were randomized 1:1:1 to receive 3+1, 3+0 and 0+2 (control Available online 11 April 2018 group; 12, 18 months doses). Nasopharyngeal/oropharyngeal swabs were obtained at all visits. Serum serotype-specific IgG concentrations and opsonic activities (OPA) were measured at 2, 7, 13 and 19 Keywords: months. This study was registered with Current Controlled Trials, Ltd. ISRCTN28445844. Pneumococcal conjugate vaccines Results: Overall, 544 infants were enrolled: 3+1 (n = 178), 3+0 (n = 178) and 0+2 (n = 188). -
Wellcome Investigators March 2011
Wellcome Trust Investigator Awards Feedback from Expert Review Group members 28 March 2011 1 Roughly 7 months between application and final outcome The Expert Review Groups 1. Cell and Developmental Biology 2. Cellular and Molecular Neuroscience (Zaf Bashir) 3. Cognitive Neuroscience and Mental Health 4. Genetics, Genomics and Population Research (George Davey Smith) 5. Immune Systems in Health and Disease (David Wraith) 6. Molecular Basis of Cell Function 7. Pathogen Biology and Disease Transmission 8. Physiology in Health and Disease (Paul Martin) 9. Population and Public Health (Rona Campbell) 2 Summary Feedback from ERG Panels • The bar is very high across all nine panels • Track record led - CV must demonstrate a substantial impact of your research (e.g. high impact journals, record of ground breaking research, clear upward trajectory etc) To paraphrase Walport ‘to support scientists with the best track records, obviously appropriate to the stage in their career’ • Notable esteem factors (but note ‘several FRSs were not shortlisted’) • Your novelty of your research vision is CRUCIAL. Don’t just carry on doing more of the same • The Trust is not averse to risk (but what about ERG panel members?) • Success rate for short-listing for interview is ~15-25% at Senior Investigator level (3-5 proposals shortlisted from each ERG) • Fewer New Investigator than Senior Investigator applications – an opportunity? • There are fewer applications overall for the second round, but ‘the bar will not be lowered’ The Challenge UoB has roughly 45 existing -
Conference Ontyph Id
10th INTERNATIONAL CONFERENCE ON TYPH ID & OTHER INVASIVE SALMONELLOSES April 4–6, 2017 | Kampala, Uganda 10th INTERNATIONAL CONFERENCE ON TYPH ID & OTHER INVASIVE SALMONELLOSES WELCOME April 4–6, 2017 | Kampala, Uganda THE WORLD NEEDS ACTION ON TYPHOID — BUILDING EVIDENCE AND REFINING STRATEGIES The Coalition against Typhoid, housed at the Sabin Vaccine Institute, welcomes you to the 10th International Conference on Typhoid and Other Invasive Salmonelloses. We are pleased to provide a forum for more than 300 researchers, policy makers, immunization managers and advocates to come together to share the latest developments and best strategies to reduce the burden of typhoid, paratyphoid and nontyphoidal salmonelloses (NTS) on communities around the world. The conference theme, “From Evidence to Action,” is timely as we prepare for the introduction of new typhoid conjugate vaccines. The research, evidence and ideas shared this week in Kampala will provide the foundation for global action against typhoid, paratyphoid and NTS. Together, we will review crucial developments to reduce the global burden of these diseases, including results from major surveillance projects in Africa and Asia, the potential of human infection models and strategies for countering antibiotic resistance. The program will also highlight outbreak control methods, exciting innovations in diagnostics, water, sanitation and hygiene strategies for prevention, and policy measures aimed at accelerating the implementation of these interventions. The coming availability of a new generation of typhoid conjugate vaccines makes this a pivotal moment for global action on typhoid. These promising new vaccines offer important advantages over prior vaccines, including longer duration of protection, the ability to protect young children, and the potential for administration with other vaccines in routine immunization of infants. -
Peter Hotez, M.D., Ph.D. Biography
Peter Hotez, MD, PhD, FASTMH, FAAP Peter J. Hotez, M.D., Ph.D., is professor of pediatrics and Molecular Virology and Microbiology at Baylor College of Medicine where he is also chief of a new Section of Pediatric Tropical Medicine and founding Dean of the National School of Tropical Medicine. In addition Prof. Hotez is the Texas Children's Hospital Endowed Chair of Tropical Pediatrics, and president of the Sabin Vaccine Institute. He will lead the new Sabin vaccine development program at Texas Children's Hospital and Baylor College of Medicine. He moves to BCM and Texas Children's from The George Washington University, where he has served as a Distinguished Research Professor and the Walter G. Ross Professor and Chair of the Department of Microbiology, Immunology and Tropical Medicine. Dr. Hotez is an internationally-recognized clinician and investigator in neglected tropical diseases and vaccine development. Diseases he studies include hookworm, schistosomiasis, Chagas disease, leishmaniasis, and malaria, among others, impacting hundreds of millions of children and adults worldwide. He obtained his undergraduate degree in molecular biophysics from Yale University in 1980, followed by a Ph.D. degree in biochemical parasitology from Rockefeller University in 1986 and a medical degree from Cornell University in 1987. He completed pediatric residency training at Massachusetts General Hospital from 1987 to 1989 and postdoctoral fellowship training in infectious diseases and molecular parasitology at Yale from 1989 to 1991. Dr. Hotez joined the Yale faculty as an assistant professor of pediatrics in 1992. He became an associate professor in 1995 before moving to the George Washington University as professor and chair in 2000. -
Protocol for a Controlled Human Infection with Genetically Modified Neisseria Lactamica Expressing the Meningococcal Vaccine
Open access Protocol Protocol for a controlled human BMJ Open: first published as 10.1136/bmjopen-2018-026544 on 1 May 2019. Downloaded from infection with genetically modified Neisseria lactamica expressing the meningococcal vaccine antigen NadA: a potent new technique for experimental medicine Diane Gbesemete,1,2 Jay Robert Laver,3 Hans de Graaf,1,2 Muktar Ibrahim,3 Andrew Vaughan,3 Saul Faust,1 Andrew Gorringe,4 Robert Charles Read 3,5 To cite: Gbesemete D, Laver JR, ABSTRACT Strengths and limitations of this study de Graaf H, et al. Protocol for Introduction Neisseria lactamica is a commensal a controlled human infection organism found in the human nasopharynx and is closely with genetically modified ► This human challenge study using a genetically related to the pathogen N. meningitidis (meningococcus). Neisseria lactamica expressing modified organism will provide insight into the role Carriage of N. lactamica is associated with reduced the meningococcal vaccine of a specific bacterial antigen in nasopharyngeal meningococcal carriage and disease. We summarise an antigen NadA: a potent new carriage and immunity, and provide a novel means ethically approved protocol for an experimental human technique for experimental to test the herd-immunity potential of vaccines. medicine. challenge study using a genetically modified strain of BMJ Open ► Safety is the first priority and has been considered at 2019;9:e026544. doi:10.1136/ N. lactamica that expresses the meningococcal antigen all points of the study design with extensive preclin- bmjopen-2018-026544 NadA. We aim to develop a model to study the role of ical testing, a period of admission for close obser- specific bacterial antigens in nasopharyngeal carriage ► Prepublication history and vation following inoculation and stringent infection and immunity, to evaluate vaccines for their efficacy in additional material for this control rules throughout the study. -
Contents Immigration and Asylum
Supported by Minority Ethnic Matters Overview 22 February 2021 ISSUE 694 MEMO is produced by the Scottish Council of Jewish Communities (SCoJeC) in partnership with BEMIS – empowering Scotland's ethnic and cultural minority communities. It provides an overview of information of interest to minority ethnic communities in Scotland, including parliamentary activity at Holyrood and Westminster, new publications, consultations, forthcoming conferences, and news reports. Contents Immigration and Asylum Bills in Progress Community Relations Consultations Equality Job Opportunities Racism, Religious Hatred, and Discrimination Funding Opportunities Other Scottish Parliament and Government Events, Conferences, and Training Health Information: Coronavirus (COVID-19) Useful Links Other News Back issues Note that some weblinks, particularly of newspaper articles, are only valid for a short period of time, usually around a month, and that the Scottish and UK Parliament and Government websites have been redesigned, so that links published in previous issues of MEMO may no longer work. To find archive material on these websites, copy details from MEMO into the relevant search facility. Please send information for inclusion in MEMO to [email protected] and click here to be added to the mailing list. The UK Parliament returns from recess on 22 February 2021. Immigration and Asylum UK Parliament, House of Commons Written Answers British Nationality: Applications Meg Hillier (Labour Co-op) [150715] To ask the Secretary of State for the Home Department, what fee changes she plans to propose for British Citizenship applications in the 2021-22 financial year. Reply from Kevin Foster: We keep our fees for immigration and nationality applications under review and ensure they are within the parameters agreed with HM Treasury and Parliament, as set out in Section 68 (9) of the Immigration Act 2014. -
Genomics 2016
Quantitative Genomics 2016 Student Conference QUANTITATIVE 6 June GENOMICS 2016 University College London (UCL) ! @quantgen16 #quantgen16 Content Page Conference programme 2 Keynote Talks 4 Sponsored Talk 5 Meet the organisers 6 Abstracts: sessions 7 Abstracts: poster presentations 21 Sponsored by Page 1& Quantitative Genomics 2016 Conference programme, first half Registration and coffee 9:00 – 9.30 Session 1: Complex Phenotype Genetics 9.30 – 10.30 9.30 - 9.45 · Hannes Svardal, Wellcome Trust Sanger Institute Africa-wide whole genome sequencing of vervet monkeys reveals strong polygenic selection on known HIV-interacting genes and on genes up-regulated after infection with the simian immunodeficiency virus (SIV) 9.45 - 9.50 · Jonathan Coleman, Institute of Psychiatry, Psychology and Neuroscience, King’s College London The contribution of polygenic risk to the relationship between depression and body mass index in the UK Biobank 9.50 - 10.05 · Stefan Dentro, Wellcome Trust Sanger Institute Large-scale pan-cancer subclonal reconstruction analysis of whole genome sequences reveals wide-spread intra- tumour heterogeneity 10.05 - 10.10 · Eva Krapohl, King’s College London The nature of nurture: Education-associated single nucleotide polymorphisms explain variation in children's home environments and in their associations with child outcomes 10.10 - 10.25 · Hannah Meyer, European Bioinformatics Institute Understanding cardiac structure and function in humans using 4D imaging genetics. 10.25 - 10.30 · Richa Gupta, University of Helsinki Neuregulin