Preventing Ebola in Uganda: Case Study from the Makerere University School of Public Health and the Johns Hopkins Center for Health Security
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A Multicenter, Multi-Outbreak, Randomized, Controlled Safety And
2018 Ebola MCM RCT Protocol Page 1 of 92 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for the Treatment of Patients with Ebola Virus Disease Short Title: 2018 Ebola MCM RCT Protocol Sponsored by: Office of Clinical Research Policy and Regulatory Operations (OCRPRO) National Institute of Allergy and Infectious Diseases 5601 Fishers Lane Bethesda, MD 20892 NIH Protocol Number: 19-I-0003 Protocol IND #: 125530 ClinicalTrials.gov Number: NCT03719586 Date: 4 October 2019 Version: 7.0 CONFIDENTIAL This document is confidential. No part of it may be transmitted, reproduced, published, or used by other persons without prior written authorization from the study sponsor and principal investigator. 2018 Ebola MCM RCT Protocol Page 2 of 92 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 KEY ROLES DRC Principal Investigator: Jean-Jacques Muyembe-Tamfum, MD, PhD Director-General, DRC National Institute for Biomedical Research Professor of Microbiology, Kinshasa University Medical School Kinshasa Gombe Democratic Republic of the Congo Phone: +243 898949289 Email: [email protected] Other International Investigators: see Appendix E Statistical Lead: Lori Dodd, PhD Biostatistics Research Branch, DCR, NIAID 5601 Fishers Lane, Room 4C31 Rockville, MD 20852 Phone: 240-669-5247 Email: [email protected] U.S. Principal Investigator: Richard T. Davey, Jr., MD Clinical Research Section, LIR, NIAID, NIH Building 10, Room 4-1479, Bethesda, -
Signature Redacted Signature of Author
Developing VHH-based tools to study Ebolavirus Infection By Jason V. M. H. Nguyen B.S., Biochemistry and Molecular Biology University of California, Santa Cruz, 2012 Submitted to the Microbiology Graduate Program in partial fulfillment of the requirements for the degree of Doctor of Philosophy At the Massachusetts Institute of Technology June 2019 2019 Massachusetts Institute of Technology. All rights reserved. Signature redacted Signature of Author...... .................................................................... V Y' Jason V. M. H. Nguyen Microbiology Graduate Program May 13, 2019 Signature redacted Certified by.............. ................................................................... Hidde L. Ploegh Senior Investigator Boston Children's Hospital It Signature redacted Accepted by....... ......................................................................... Jacquin C. Niles Associate Professor of Biological Engineering Chair of Microbiology Program MASSACHUSETTS INSTITUTE OF TECHNOLOGY JUN 2 12019 1 LIBRARIES ARCHIVES 2 Developing VHH-based tools to study Ebolavirus Infection By Jason V. M. H. Nguyen Submitted to the Microbiology Graduate Program on May 13th, 2019 in partial fulfillment of the requirements for the degree of Doctor of Philosophy ABSTRACT Variable domains of camelid-derived heavy chain-only antibodies, or VHHs, have emerged as a unique antigen binding moiety that holds promise in its versatility and utilization as a tool to study biological questions. This thesis focuses on two aspects on developing tools to study infectious disease, specifically Ebolavirus entry. In Chapter 1, I provide an overview about antibodies and how antibodies have transformed the biomedical field and how single domain antibody fragments, or VHHs, have entered this arena. I will also touch upon how VHHs have been used in various fields and certain aspects that remain underexplored. Chapter 2 focuses on the utilization of VHHs to study Ebolavirus entry using VHHs that were isolated from alpacas. -
Ebola Hemorrhagic Fever: Properties of the Pathogen and Development of Vaccines and Chemotherapeutic Agents O
ISSN 00268933, Molecular Biology, 2015, Vol. 49, No. 4, pp. 480–493. © Pleiades Publishing, Inc., 2015. Original Russian Text © O.I. Kiselev, A.V. Vasin, M.P. Shevyryova, E.G. Deeva, K.V. Sivak, V.V. Egorov, V.B. Tsvetkov, A.Yu. Egorov, E.A. RomanovskayaRomanko, L.A. Stepanova, A.B. Komissarov, L.M. Tsybalova, G.M. Ignatjev, 2015, published in Molekulyarnaya Biologiya, 2015, Vol. 49, No. 4, pp. 541–554. REVIEWS UDC 578.2,578.76 Ebola Hemorrhagic Fever: Properties of the Pathogen and Development of Vaccines and Chemotherapeutic Agents O. I. Kiseleva, A. V. Vasina, b, M. P. Shevyryovac, E. G. Deevaa, K. V. Sivaka, V. V. Egorova, V. B. Tsvetkova, d, A. Yu. Egorova, E. A. RomanovskayaRomankoa, L. A. Stepanovaa, A. B. Komissarova, L. M. Tsybalovaa, and G. M. Ignatjeva a Institute of Influenza, Ministry of Health of the Russian Federation, St. Petersburg, 197376 Russia; email: [email protected] b St. Petersburg State Polytechnic University, St. Petersburg, 195251 Russia c Ministry of Health of the Russian Federation, Moscow, 127994 Russia d Topchiev Institute of Petrochemical Synthesis, Moscow, 119991 Russia Received December 29, 2014; in final form, January 16, 2015 Abstract—Ebola hemorrhagic fever (EHF) epidemic currently ongoing in West Africa is not the first among numerous epidemics in the continent. Yet it seems to be the worst EHF epidemic outbreak caused by Ebola virus Zaire since 1976 as regards its extremely large scale and rapid spread in the population. Experiments to study the agent have continued for more than 20 years. The EHF virus has a relatively simple genome with seven genes and additional reading frame resulting from RNA editing. -
Program of the 4Th Scientific Conference
Makerere University College of Health Sciences Program for the 7th Annual Scientific Conference 20th – 22nd September 2011; Speke Resort Munyonyo Kampala, Uganda 20th SEPTEMBER 2011 Abstract No. Time Presentation 8.00-8.30 Arrival and registration PLENARY Chair: Dr Rhoda Wanyenze; Co-Chair: Dr. Freddie Bwanga 8.30 - 9.00 Key note address – All for Health – One Health: Dr. Jane Aceng Director General MOH PLENARY Health Systems, Health Policy & Healthcare Chair: Prof Fredrick Wabwire-Mangen; Co-Chair: Prof. David Guwatudde PP1001_20 9.00-9.10 Health Systems, Governance and Health Outcome: Dr. Freddie Ssengoba PP1002_20 9.10-9.20 Challenges and Future Systems in Uganda to Ensure Delivery of Quality Care: Dr. Robert Basaza PP1003_20 9.20-9.30 Transforming Education to Strengthen Health Systems in an Inter-department World: Prof. David Serwadda 9.30-9:40 DISCUSSION PP1004_20 9:40-9:50 Role of Cultural Institutions in Healthcare Delivery, Disease Prevention and Health Promotion: Dr. Nelson Kawalya PP1005_20 9:50-10:00 Impact of Private for Profit Institutions in Healthcare Delivery and Health Systems Strengthening: Dr. Ian Clarke PP1006_20 10:00-10:10 HIV/AIDS programming through District based technical assistance programme: Experience from STAR-EC: Dr. Samson Kironde 10:10-10:20 DISCUSSION 10:20-10:50 TEA BREAK OFFICIAL OPENING CEREMONY: MC – Prof. Harriet Mayanja; Co-MC: Mr. Gerald Makumbi 10:50-10.55 Welcome remarks by Chair, 7ASC Organising Committee MakCHS: Dr. Freddie Bwanga 10.55-11.10 Announcement of the Bill & Melinda Gates Research Grant for Africa: Dr. Wong 11.10-11.10 Remarks on Translating Research into Policy and Healthcare Delivery by Chair, Research College of Health Sciences Makerere University: Prof. -
Accelerating R&D for Emerging Infectious Diseases: Lessons
Accelerating R&D for Emerging Infectious Diseases: Lessons Learnt From Ebola Chao Li China CDC Jingyi Chen Harvard University Jiyan Ma Peking University Health Science Centre Yangmu Huang ( [email protected] ) Peking University Health Science Centre https://orcid.org/0000-0002-3660-1276 Research Article Keywords: Ebola Virus Disease, Emerging Infectious Disease, Research and Development Posted Date: July 2nd, 2020 DOI: https://doi.org/10.21203/rs.3.rs-38612/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/12 Abstract Objective: The R&D explosion for Ebola virus disease (EVD) during the 2014-2016 outbreak led to the successful development of high-quality vaccines performed by China and the U.S. This study aims to compare the R&D activities of Ebola-related medical products in two countries, as a way to present the inuential factors of R&D for emerging infectious disease (EID) and to provide suggestions for timely and ecient R&D response to the COVID-19 pandemic. Methods: In this comparative study, R&D activities were analyzed in terms of research funding, scientic research outputs, R&D timeline, and government incentive and coordinated mechanisms. Quantitative analysis was performed using data retrieved from national websites, clinical trial registries and databases.Qualitative semi-structured interviews were conducted to explore perspectives of fteen key informants from EID eld, especially of those involved in Ebola product development. Findings: The funding gap between China and the U.S. was signicant before 2014 and narrowed after the Ebola outbreak. Both research teams started basic studies prior to the Ebola outbreak; however, the U.S. -
Joint Press Release Between Africa Cdc and Who on The
Press Release No…… JOINT PRESS RELEASE BETWEEN AFRICA CENTRES FOR DISEASE CONTROL AND PREVENTION AND THE WORLD HEALTH ORGANIZATION ON THE SITUATION OF EBOLA VIRUS DISEASE OUTBREAK IN THE DEMOCRATIC REPUBLIC OF CONGO Addis Ababa, Ethiopia & Brazzaville, Republic of Congo, 19 July 2019. On 17 July 2019, the World Health Organisation (WHO) Director General, Dr Tedros Adhanom GheBreyesus, declared the ongoing EBola virus disease (EVD) outbreak in the Democratic RepuBlic of Congo (DRC) as a Public Health Emergency of International Concern (PHEIC). A PHEIC is defined in the IHR (2005) as, “an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response”i. As of 18 July 2019, the Ministry of PuBlic Health of the DRC reported 2,532 cases (2,438 confirmed and 94 probable) with 1,705 deaths and 718 cured. In declaring the DRC EVD outbreak a PHEIC, the WHO took into consideration the first confirmed case in Goma, a city of almost two million inhaBitants and close to the border with Rwanda, and the gateway to the rest of DRC and the world. Between 2009 and 2019, there have been five PHEIC declarations.ii Declaration of a PHEIC is a call to action. Therefore, it is time for the African continent and indeed the world to redouble our efforts in solidarity with the DRC to end this outBreak and Build a stronger health system. In view of the PHEIC declaration, Africa Centres for Disease Control and Prevention (Africa CDC) and the WHO Regional Office for Africa would like to reiterate the need for all Member States to adhere to the recommendations made, emphasising the following: • No country should close its borders or place any restrictions on travel and trade, including general quarantine of travelers from the Ebola-affected countries, currently the DRC. -
2019 Icar Program & Abstracts Book
Hosted by the International Society for Antiviral Research (ISAR) ND International Conference 32on Antiviral Research (ICAR) Baltimore MARYLAND PROGRAM and USA Hyatt Regency BALTIMORE ABSTRACTS May 12-15 2019 ND TABLE OF International Conference CONTENTS 32on Antiviral Research (ICAR) Daily Schedule . .3 Organization . 4 Contributors . 5 Keynotes & Networking . 6 Schedule at a Glance . 7 ISAR Awardees . 10 The 2019 Chu Family Foundation Scholarship Awardees . 15 Speaker Biographies . 17 Program Schedule . .25 Posters . 37 Abstracts . 53 Author Index . 130 PROGRAM and ABSTRACTS of the 32nd International Conference on Antiviral Research (ICAR) 2 ND DAILY International Conference SCHEDULE 32on Antiviral Research (ICAR) SUNDAY, MAY 12, 2019 › Women in Science Roundtable › Welcome and Keynote Lectures › Antonín Holý Memorial Award Lecture › Influenza Symposium › Opening Reception MONDAY, MAY 13, 2019 › Women in Science Award Lecture › Emerging Virus Symposium › Short Presentations 1 › Poster Session 1 › Retrovirus Symposium › ISAR Award of Excellence Presentation › PechaKucha Event with Introduction of First Time Attendees TUESDAY, MAY 14, 2019 › What’s New in Antiviral Research 1 › Short Presentations 2 & 3 › ISAR Award for Outstanding Contributions to the Society Presentation › Career Development Panel › William Prusoff Young Investigator Award Lecture › Medicinal Chemistry Symposium › Poster Session 2 › Networking Reception WEDNESDAY, MAY 15, 2019 › Gertrude Elion Memorial Award Lecture › What’s New in Antiviral Research 2 › Shotgun Oral -
To Ebola Reston
WHO/HSE/EPR/2009.2 WHO experts consultation on Ebola Reston pathogenicity in humans Geneva, Switzerland 1 April 2009 EPIDEMIC AND PANDEMIC ALERT AND RESPONSE WHO experts consultation on Ebola Reston pathogenicity in humans Geneva, Switzerland 1 April 2009 © World Health Organization 2009 All rights reserved. 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 distin- guished 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 express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication contains the collective views of an international group of experts and does not necessarily represent the decisions or the policies of the World Health Organization. -
How Severe and Prevalent Are Ebola and Marburg Viruses?
Nyakarahuka et al. BMC Infectious Diseases (2016) 16:708 DOI 10.1186/s12879-016-2045-6 RESEARCHARTICLE Open Access How severe and prevalent are Ebola and Marburg viruses? A systematic review and meta-analysis of the case fatality rates and seroprevalence Luke Nyakarahuka1,2,5* , Clovice Kankya2, Randi Krontveit3, Benjamin Mayer4, Frank N. Mwiine2, Julius Lutwama5 and Eystein Skjerve1 Abstract Background: Ebola and Marburg virus diseases are said to occur at a low prevalence, but are very severe diseases with high lethalities. The fatality rates reported in different outbreaks ranged from 24–100%. In addition, sero-surveys conducted have shown different seropositivity for both Ebola and Marburg viruses. We aimed to use a meta-analysis approach to estimate the case fatality and seroprevalence rates of these filoviruses, providing vital information for epidemic response and preparedness in countries affected by these diseases. Methods: Published literature was retrieved through a search of databases. Articles were included if they reported number of deaths, cases, and seropositivity. We further cross-referenced with ministries of health, WHO and CDC databases. The effect size was proportion represented by case fatality rate (CFR) and seroprevalence. Analysis was done using the metaprop command in STATA. Results: The weighted average CFR of Ebola virus disease was estimated to be 65.0% [95% CI (54.0–76.0%), I2 = 97.98%] whereas that of Marburg virus disease was 53.8% (26.5–80.0%, I2 = 88.6%). The overall seroprevalence of Ebola virus was 8.0% (5.0%–11.0%, I2 = 98.7%), whereas that for Marburg virus was 1.2% (0.5–2.0%, I2 = 94.8%). -
Development of an Antibody Cocktail for Treatment of Sudan Virus Infection
Development of an antibody cocktail for treatment of Sudan virus infection Andrew S. Herberta,b, Jeffery W. Froudea,1, Ramon A. Ortiza, Ana I. Kuehnea, Danielle E. Doroskya, Russell R. Bakkena, Samantha E. Zaka,b, Nicole M. Josleyna,b, Konstantin Musiychukc, R. Mark Jonesc, Brian Greenc, Stephen J. Streatfieldc, Anna Z. Wecd,2, Natasha Bohorovae, Ognian Bohorove, Do H. Kime, Michael H. Paulye, Jesus Velascoe, Kevin J. Whaleye, Spencer W. Stoniera,b,3, Zachary A. Bornholdte, Kartik Chandrand, Larry Zeitline, Darryl Sampeyf, Vidadi Yusibovc,4, and John M. Dyea,5 aVirology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702; bThe Geneva Foundation, Tacoma, WA 98402; cFraunhofer USA Center for Molecular Biotechnology, Newark, DE 19711; dDepartment of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, NY 10461; eMapp Biopharmaceutical, Inc., San Diego, CA 92121; and fBioFactura, Inc., Frederick, MD 21701 Edited by Y. Kawaoka, University of Wisconsin–Madison/University of Tokyo, Madison, WI, and approved December 30, 2019 (received for review August 28, 2019) Antibody-based therapies are a promising treatment option for antibody-based immunotherapies. Subsequently, several indepen- managing ebolavirus infections. Several Ebola virus (EBOV)-specific dent groups reported the postexposure efficacy of monoclonal and, more recently, pan-ebolavirus antibody cocktails have been antibody (mAb)-based immunotherapies against EVD in ma- described. Here, we report the development and assessment of a caques when administered as mixtures of two or more mAbs (14–17). Sudan virus (SUDV)-specific antibody cocktail. We produced a panel These landmark studies demonstrated that combination mAb- of SUDV glycoprotein (GP)-specific human chimeric monoclonal based immunotherapies are a viable treatment option for EVD antibodies (mAbs) using both plant and mammalian expression and spurred therapeutic antibody development for filoviruses. -
Understanding Ebola
Understanding Ebola With the arrival of Ebola in the United States, it's very easy to develop fears that the outbreak that has occurred in Africa will suddenly take shape in your state and local community. It's important to remember that unless you come in direct contact with someone who is infected with the disease, you and your family will remain safe. State and government agencies have been making preparations to address isolated cases of infection and stop the spread of the disease as soon as it has been positively identified. Every day, the Centers of Disease Control and Prevention (CDC) is monitoring developments, testing for suspected cases and safeguarding our lives with updates on events and the distribution of educational resources. Learning more about Ebola and understanding how it's contracted and spread will help you put aside irrational concerns and control any fears you might have about Ebola severely impacting your life. Use the resources below to help keep yourself calm and focused during this unfortunate time. Ebola Hemorrhagic Fever Ebola hemorrhagic fever (Ebola HF) is one of numerous Viral Hemorrhagic Fevers. It is a severe, often fatal disease in humans and nonhuman primates (such as monkeys, gorillas, and chimpanzees). Ebola HF is caused by infection with a virus of the family Filoviridae, genus Ebolavirus. When infection occurs, symptoms usually begin abruptly. The first Ebolavirus species was discovered in 1976 in what is now the Democratic Republic of the Congo near the Ebola River. Since then, outbreaks have appeared sporadically. There are five identified subspecies of Ebolavirus. -
Overview of Candidate Ebola Vaccines As of August 19, 2019
Ebola vaccines – Background paper for SAGE deliberations Overview of candidate Ebola vaccines as of August 19, 2019 Nine candidate Ebola vaccines have undergone or are currently undergoing clinical evaluation at different trial phases. Three vaccines were licensed, three vaccines have completed or are in trials up to Phase 1 phase, two vaccines up to or in Phase 2 stage, and one vaccine has completed Phase 3 stage. Type of Developer Strain(s) a. Current stage of clinical Proposed Proposed Proposed target Current storage Current formulation Number of clinical Forecasted production candidate aimed to evaluation vaccination indication population for the specifications* and presentation research grade does capacity vaccine protect schedule label indication available against b. Number of subjects with data (doses per vial) analysed to date c. Regulatory status PROPOSED INDICATION: REACTIVE USE DURING OUTBREAKS Licensed in country of origin Ad5-EBOV CanSino Biologics Zaire a. Phase 1 in China and Phase 2 in 1 dose Reactive 18 to 60 years +2°C to +8°C for 12 Final Formulation: 20,000 doses Can produce 150 000 (monovalent)1 Inc. & Beijing ebolavirus Sierra Leone months Lyophilized doses per year and Institute of (Makona) b. >681 people enrolled potentially scale-up to 500 Biotechnology, c. Licensed obtained from CFDA in 000 doses/year. China October 2017 to use under national Presentation: reserves by National Medical Single dose vial + Products Administration (NMPA), diluent China in the event of Ebola outbreak Submitted to WHO for Emergency Use Assessment and Listing (EUAL) in July 2018. Granted Breakthrough Therapy Designation by the US FDA and PRIME status by the European Medicines Agency (EMA) since 2016 rVSVΔG- Merck, USA Monovalent a.