WP6 (Lead Partner RUG) Clinical Trial Program
|
|
|
- Barnaby Harrison
- 5 years ago
- Views:
Transcription
1 WP6 (Lead Partner RUG) Clinical Trial Program Eelko Hak, Work Package leader Groningen Research Institute of Pharmacy & Epidemiology, University of Groningen
2 Double-Blind Randomized Controlled Phase IIb Vaccine Trials Aim: To evaluate the safety and immunogenicity of two universal influenza vaccines targeting different conserved immunogenic regions of influenza A and B viruses. 2 FLU-v (SEEK, UK) and M-001 (BiondVax, Israel) are both peptide based vaccines containing epitopes identified from the viral internal (structural) proteins. M-001 contains also epitopes from the viral surface glycoproteins. While FLU-v is composed of synthetic polypeptides, M-001 is composed of a single recombinant protein.
3 Double-Blind Randomized Controlled Phase IIb Vaccine Trials (cont.) Trial participants: Healthy adults aged years, not among the target groups for influenza vaccination. Sample size estimation: Determined on the basis of influenza-specific interferon-γ responses observed from their earlier trials. FLU-v study: fold increase of influenza-specific interferon-γ responses measured by ELISA. M-001 study: fold increase of influenza-specific interferon-γ secreting CD8+ T cells measured by FACS analysis. Two-sided alfa of 5%, power of 80% with continuity correction. Taking a loss to follow up into account, we will include 222 subjects in total (74 subjects per experimental arm). 3
4 Study Layout 1 Consortium 2 Trials 3 Treatment arms 2x M-001 (low dose) + 1x H5 pandemic vaccine (n= 74) M-001 trial (n=222) 2x M-001 (high dose) + 1x H5 pandemic vaccine (n=74) 2x saline + 1x H5 pandemic vaccine (n=74) UNISEC 2x Flu-v (n=74) FLU-v trial (n=222) 1x adjuvanted FLU-v + 1x saline (n=74) 2x saline (n=37) 4 1x adjuvanted WFI (water for injection) + 1x saline (n=37)
5 Study endpoints Safety AE diary cards and questionnaires will be collected until 180 days after the first dosing. Immune Correlates of Protection Cellular immunity will be assessed on day 42 (21 days after the second administration). For FLU-v study, cellular immunity on day 180 (159 days after the second administration) will also be assessed. Antibody responses on day 42 and 180 will be evaluated. For M-001 study, cellular and humoral immunity (HI) will be assessed 21 days after the H5 pandemic vaccination. 5 A maximum of 187 days (from screening to study conclusion) study participation, covering one influenza season.
6 Exploratory endpoints M-001 trial Additional CMI measures (qrt-pcr assay). Humoral immunity (HI) against drifted H5N1 strains. Association between CMI markers and antibody responses measured in the study. 6 FLU-v trial Clinical efficacy Clinical symptom score ( to be collected during the influenza epidemic season (December-March)). RT-PCR confirmed influenza infections Additional CMI measures. Antibody responses. Isotyping of antibody responses to FLUv ADCC/ADC assays
7 Trial Logistics Clinical trial sites: St Istvan St Laszlo Hospital (Hungary) will perform the M-001 study. Isala (Zwolle, NL) is the potential site for the FLU-v study. PBMC processing sites: National Center of Epidemiology (Hungary) will process clinical samples for the M- 001 study. Isala is able to process clinical samples for the FLU-v study. Laboratories for clinical sample analysis: Robert Koch Institute is the central analytic center for clinical studies run under the UNISEC consortium (WP5 leader). Perform multi-parametric intracellular cytokine FACS analysis and IFN-γ ELISA (primary CMI endpoint). National Center of Epidemiology will analyze HAI assay and additional (exploratory) CMI endpoints for the M-001 study. National Institute Public Health (Norway) is able to measure additional (exploratory) CMI endpoints for the FLU-v study. 7
8 Data Management Will be performed by UMCG Trial Coordination Center (Iso-certified); Project manager Denise Mailly, part of WP6-team; In close collaboration with sponsors and WP partners; Case report forms on secured website; Check of data consistency and reliability; Pseudo-anonymization; Data Safety and Monitoring Board not required. 8
9 Action points BVX Submission BVX dossier to Hungarian authorities. Development of recruitment strategies in Hungary. GMP vaccine manufacturing. Development and testing IT tool data management. Statistical Analysis Plan. 9
10 Action points SEEK Further tendering GMP manufacturers. Tendering CRO. Meeting with Zwolle Isala Clinics. Meeting with National Institute Public Health. Submission SEEK dossier to NL authorities. Development of recruitment strategies in Zwolle. GMP vaccine manufacturing. Development and testing IT tool datamanagement. Statistical Analysis Plan. 10
11 Timelines Protocols/ Audits Oct Mar 2015 ERB/ Trial no. Mar 2015-Jun 2015 BVX Trial Aug May 2016 Comparative (metaanalytic) study July-Sept 2017 Report Oct 2017 Batch information needed from GMP producer SEEK trial possibly delayed with 6-12 months 11
UNISEC Universal Influenza Vaccines Secured
UNISEC Universal Influenza Vaccines Secured Partners in the UNISEC Consortium UNISEC has been made possible by contributions from the European Commission DG-Research and the European member states Project
Dr Olga Pleguezuelos CSO and Project Manager at SEEK
Dr Olga Pleguezuelos CSO and Project Manager at SEEK Imutex Limited, formed in 2016, is a joint venture between SEEK Group and hvivo to accelerate the development of a Mosquito Vaccine (AGS-v) and Broad-
hvivo plc ( hvivo or the Company )
hvivo plc ( hvivo or the Company ) hvivo reports positive results from the Phase IIb field study of FLU-v (FLU-v 003) representing a significant advance in the management of influenza disease Primary and
UNISEC Universal Influenza Vaccines Secured
UNISEC Universal Influenza Vaccines Secured Partners in the UNISEC Consortium UNISEC has been made possible by contributions from the European Commission DG-Research and the European member states Project
Universal Influenza Vaccine One For All
Universal Influenza Vaccine One For All MIXiii Conference, May 2014 Forward Looking Statements 2 This presentation includes forward-looking statements within the meaning of applicable securities laws.
Min Levine, Ph. D. Influenza Division US Centers for Disease Control and Prevention. June 18, 2015 NIBSC
Workshop on Immunoassay Standardization for Universal Flu Vaccines Min Levine, Ph. D. Influenza Division US Centers for Disease Control and Prevention June 18, 2015 NIBSC 1 Multiple Immune Mechanisms Contribute
University of Groningen
University of Groningen Evaluation of the immunogenicity and safety of different doses and formulations of a broad spectrum influenza vaccine (FLU-v) developed by SEEK van Doorn, Eva; Pleguezuelos, Olga;
Developing Understanding of CMI. Dr Tom Wilkinson Associate Professor of Respiratory Medicine Faculty of Medicine University of Southampton UK
Pre-existing influenza-specific CD4+ T cells correlate with homologous and heterotypic response and disease protection against influenza challenge in humans Do At Risk Groups Rely more on CMI to Viruses?
Cover Page. The handle holds various files of this Leiden University dissertation
Cover Page The handle http://hdl.handle.net/1887/35908 holds various files of this Leiden University dissertation Author: Soema, Peter Title: Formulation of influenza T cell peptides : in search of a universal
Stockpiling of H5N1 vaccines
Stockpiling of H5N1 vaccines Norbert W. Hehme EVM Influenza Pandemic Working Group EU-Commission Workshop on Stockpiling of Medicinal Products February 21/22, 2008 European Vaccine Manufacturers 1 (EVM)
Regulatory requirements for universal flu vaccines Perspective from the EU regulators
Regulatory requirements for universal flu vaccines Perspective from the EU regulators EDUFLUVAC workshop 12-14 June Marco Cavaleri Head of Anti-infectives and Vaccines Scientific & Regulatory Management
FDA Approved Recombinant Hemagglutinin Influenza Vaccine Protects Against Drift Influenza Viruses
FDA Approved Recombinant Hemagglutinin Influenza Vaccine Protects Against Drift Influenza Viruses 2 nd International conference on Flu October 31- November 02, 2016 San Francisco, California, USA Protein
FLUSECURE A consortium of European Health Institutes with vaccine development capabilities February 2006 August 2010
FLUSECURE A consortium of European Health Institutes with vaccine development capabilities February 2006 August 2010 Partners Jan Hendriks E-mail: jan.hendriks@rivm.nl 15-16 October 2012 Luxembourg Netherlands
Review on vectored influenza vaccines. Sarah Gilbert Jenner Institute Oxford
Review on vectored influenza vaccines Sarah Gilbert Jenner Institute Oxford Viral Vectored Influenza Vaccines Can be used to induce antibodies against HA Will also boost CD4 + T cell responses against
Immunological evaluation of nextgeneration. Othmar G Engelhardt
Immunological evaluation of nextgeneration influenza vaccines Othmar G Engelhardt Today s presentation Evaluation of current influenza vaccines European regulatory guidelines Evaluation of novel vaccines
MEETING THE STANDARDS: FDA MANDATORY RAPID INFLUENZA DETECTION TEST (RIDTs) RECLASSIFICATION
MEETING THE STANDARDS: FDA MANDATORY RAPID INFLUENZA DETECTION TEST (RIDTs) RECLASSIFICATION NOVEMBER 6, 2017 SALLY A. HOJVAT M.Sc., Ph.D. Retired as Director of FDA Division of Microbiology Devices, CDRH
GSK s Adjuvanted Influenza Vaccines The Taming of the Flu
GSK s Adjuvanted Influenza Vaccines The Taming of the Flu JITMM, Bangkok, October 2008 Bruce L. Innis, MD Global Clinical Research and Development GlaxoSmithKline Biologicals 1 Annual Burden of Influenza
100 years of Influenza Pandemic and the prospects for new influenza vaccines
100 years of Influenza Pandemic and the prospects for new influenza vaccines Dr John McCauley Director, WHO Collaborating Centre for Reference and Research on influenza The Francis Crick Institute London
Expedited procedure for evaluating pandemic influenza A (H1N1) 2009 vaccines
Expedited procedure for evaluating pandemic influenza A (H1N1) 2009 vaccines Preamble On 11 June 2009, WHO declared an influenza pandemic caused by influenza A (H1N1) 2009 virus 1. On 13 July 2009, WHO
Heterosubtypic immunity. Professor Ajit Lalvani FMedSci Chair of Infectious Diseases 14/07/2014
Protective cellular immune correlates against pandemic influenza: implications for universal vaccines 2 nd WHO Meeting on development and clinical trials of broadly protective influenza vaccines 5th 7th
GSK Proposed Phase 2 Program for ChAd3 EBOV Vaccine Candidate
GSK Proposed Phase 2 Program for ChAd3 EBOV Vaccine Candidate Vaccine availability for Phase 2 program Dependent upon: Dose level selected in Phase 1 Productivity of the current manufacturing process (at
100 Years since the 1918 Spanish Flu Pandemic. Current Standards for Flu Pandemic Preparedness
100 Years since the 1918 Spanish Flu Pandemic. Current Standards for Flu Pandemic Preparedness OCTOBER 16, 2018 SALLY A. HOJVAT M.Sc., Ph.D. Retired as Director of FDA Division of Microbiology Devices,
PATH Influenza Vaccine Projects
PATH Influenza Vaccine Projects Overview John W. Boslego, MD John Boslego Director, Vaccine Development Global Program March 25 th, 2014 Influenza Vaccine Project (IVP) at PATH IVP Goal: Advance the development
Update on production of plant-made influenza Virus-Like Particle (VLP) vaccine
Update on production of plant-made influenza Virus-Like Particle (VLP) vaccine January 25th 2013 Nathalie Landry Vice President of Product Development TSX: MDG OTCQX: MDCGF Forward-Looking Statements and
Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
Pandemic Influenza Preparedness
Pandemic Influenza Preparedness Of the many health threats that we are preparing for, this is the one that we know will happen. Bruce G. Gellin, MD, MPH Director, National Vaccine Program Office Department
ParActin For Cold & Flu
ParActin For Cold & Flu Colds and flu can reach epidemic proportions during the winter months. There are more than 95 million flu cases in the U.S. annually, according to the Centers for Disease Control,
Broadly protective influenza vaccines for pandemic preparedness. Suresh Mittal Department of Comparative Pathobiology Purdue University
Broadly protective influenza vaccines for pandemic preparedness Suresh Mittal Department of Comparative Pathobiology Purdue University Influenza A Virus Orthomyxovirus Consist of s/s (-) sense RNA 8 segments
Supporting Information
Supporting Information Valkenburg et al. 10.1073/pnas.1403684111 SI Materials and Methods ELISA and Microneutralization. Sera were treated with Receptor Destroying Enzyme II (RDE II, Accurate) before ELISA
Experiences with Live Attenuated Avian Influenza Vaccine Trials in Thailand
Experiences with Live Attenuated Avian Influenza Vaccine Trials in Thailand Punnee Pitisuttithum, MBBS,DTM&H,FRCPT Vaccine Trial Center,Faculty of Tropical Medicine, Mahidol University For MOPH,CDC,MU,Geneva
ARIZONA INFLUENZA SUMMARY Week 1 (1/4/2015 1/10/2015)
ARIZONA INFLUENZA SUMMARY Week 1 (1/4/2015 1/10/2015) 2014-2015 Season (9/28/2014 10/3/2015) Synopsis: Influenza activity is increasing in Arizona. Arizona reported Widespread activity for week 1. Influenza
7/14/2014. Multiple immune effector mechanisms contribute to protection influenza. What is a correlate of protection?
What is a correlate of protection? Immunological Assessment of Influenza Vaccines and Correlates of Protection Jacqueline Katz Influenza Division Centers for Disease Control and Prevention Defined immune
Studying Repeated Immunization in an Animal Model. Kanta Subbarao Laboratory of Infectious Diseases, NIAID
Studying Repeated Immunization in an Animal Model Kanta Subbarao Laboratory of Infectious Diseases, NIAID Animal models in Influenza Research Commonly used Mice Ferrets Guinea pigs Non human primates Less
Seasonal vaccine approval - EUROPEAN UNION -
Seasonal vaccine approval - EUROPEAN UNION - Jim Robertson National Institute for Biological Standards and Control National Institute for Biological Standards and Control Assuring the quality of biological
National seasonal influenza vaccination programmes in Europe
National seasonal influenza vaccination programmes in Europe Pasi Penttinen, head of disease programme (acting) Office of the Chief Scientist European Centre for Disease Prevention and Control (ECDC) Brussels,
Brief history of the development of the Framework on Sharing influenza viruses and access to vaccines and other benefits
Brief history of the development of the Framework on Sharing influenza viruses and access to vaccines and other benefits The Intergovernmental (IGM) Process Since the late 1940's, WHO has coordinated a
Therapeutic Cancer Vaccines
Therapeutic Cancer Vaccines Goal for all therapeutic cancer vaccines: To enhance the natural immune response so that it becomes an effective therapy Approaches being investigated in clinical studies: Whole
Cellular Immunity in Aging and HIV: Correlates of Protection. Immune Senescence
Cellular Immunity in Aging and HIV: Correlates of Protection Janet E. McElhaney, MD Professor of Medicine Allan M. McGavin Chair in Research Geriatrics University of British Columbia Vancouver, BC and
staining and flow cytometry
Detection of influenza virus-specific T cell responses by intracellular by cytokine intracellular staining cytokine staining and flow cytometry Detection of influenza virus-specific T cell responses and
HAI and NAI as Correlates of Protection After Influenza Vaccination
HAI and NAI as Correlates of Protection After Influenza Vaccination Arnold S. Monto Thomas Francis Jr. Professor University of Michigan School of Public Health Ann Arbor, Michigan Having Correlates is
Financing Influenza Vaccine R&D
Financing Influenza Vaccine R&D WHO GAP-II Geneve, Switzerland July 13, 2011 Robin Robinson, Ph.D. Deputy Assistant Secretary & Director HHS/ASPR/BARDA 0 Vaccine Development is Risky, Lengthy, & Expensive
NASDAQ:NVAX Novavax, Inc. All rights reserved.
Novavax vaccine induced improved immune responses against homologous and drifted A(H3N2) viruses in older adults compared to egg-based, high-dose, influenza vaccine World Vaccine Congress April 4, 2018
VIROLOGY OF INFLUENZA. Subtypes: A - Causes outbreak B - Causes outbreaks C - Does not cause outbreaks
INFLUENZA VIROLOGY OF INFLUENZA Subtypes: A - Causes outbreak B - Causes outbreaks C - Does not cause outbreaks PATHOGENICITY High pathogenicity avian influenza (HPAI) Causes severe disease in poultry
Technology Overview. Summary
Live Attenuated Influenza Vaccines with Altered NS1 Technology Overview Summary Transformative Technology: Live attenuated influenza vaccines (LAIVs) with precise, genetically stable truncations of the
Development of Recombinant MERS-CoV Spike (S) Nanoparticle Vaccine
Development of Recombinant MERS-CoV Spike (S) Nanoparticle Vaccine Russell P. Wilson Senior Vice President, Business Development Vaccine World MENA & CIS 2014 Istanbul, Turkey November 19, 2014 1 www.novavax.com
24 26 January 2013, Hong Kong SAR, CHINA. TITLE from VIEW and SLIDE MASTER February 27, 2013
The first WHO integrated meeting on development and clinical trials of influenza vaccines that induce broadly protective and long-lasting immune responses 24 26 January 2013, Hong Kong SAR, CHINA 1 TITLE
Promoting Public Health Security Addressing Avian Influenza A Viruses and Other Emerging Diseases
Promoting Public Health Security Addressing Avian Influenza A Viruses and Other Emerging Diseases Masaya Kato, WHO Viet Nam OIE Regional Workshop on Enhancing Influenza A viruses National Surveillance
Regulatory Challenges for Influenza Vaccines 1
Regulatory Challenges for Influenza Vaccines 1 Regulatory Challenges for Influenza Vaccines Leonoor Wijnans - Influenza Summer School Siena, 19 July 2012 Regulatory challenges for influenza vaccines Regulatory
Acute respiratory illness This is a disease that typically affects the airways in the nose and throat (the upper respiratory tract).
Influenza glossary Adapted from the Centers for Disease Control and Prevention, US https://www.cdc.gov/flu/glossary/index.htm and the World Health Organization http://www.wpro.who.int/emerging_diseases/glossary_rev_sept28.pdf?ua=1
Review of Influenza Activity in San Diego County
2015 Kick the Flu Summit Review of Influenza Activity in San Diego County 2014-2015 Season Jeffrey Johnson, MPH Senior Epidemiologist Epidemiology & Immunization Services Branch Public Health Services
Global Health Security: Preparedness and Response: can we do better and stay safe?
Global Health Security: Preparedness and Response: can we do better and stay safe? John Watson Health Protection Directorate, Public Health England Formerly Deputy Chief Medical Officer, Department of
Flu Watch. MMWR Week 3: January 14 to January 20, and Deaths. Virologic Surveillance. Influenza-Like Illness Surveillance
Flu Watch MMWR Week 3: January 14 to January 2, 218 All data are provisional and subject to change as more reports are received. Geographic Spread South Carolina reported widespread activity this week.
EMA revised guidelines applicable to pandemic vaccines.
EMA revised guidelines applicable to pandemic vaccines. Presented on 29 April 2015 by Thomas Girard Regulatory Affairs Officer Regulatory Affairs Office Manuela Mura - Scientific Officer Anti-infectives
Flu Watch. MMWR Week 4: January 21 to January 27, and Deaths. Virologic Surveillance. Influenza-Like Illness Surveillance
Flu Watch MMWR Week 4: January 21 to January 27, 218 All data are provisional and subject to change as more reports are received. Geographic Spread South Carolina reported widespread activity this week.
GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
7th Mena Influenza Stakeholders Meeting. WHO Influenza Strategy Development and Vaccine-related Research Priorities
7th Mena Influenza Stakeholders Meeting WHO Influenza Strategy Development and Vaccine-related Research Priorities Wenqing Zhang 9 10 September 2017 Riga, Latvia 1 Seasonal influenza 1 billion cases yearly
RESULTS SUMMARY. 45 Poplar Road Parkville, Victoria 3052 Australia. 31 May 2005 (First Participant, First Visit [FPFV]) Not applicable
![RESULTS SUMMARY. 45 Poplar Road Parkville, Victoria 3052 Australia. 31 May 2005 (First Participant, First Visit [FPFV]) Not applicable](/thumbs/95/123943619.jpg "RESULTS SUMMARY. 45 Poplar Road Parkville, Victoria 3052 Australia. 31 May 2005 (First Participant, First Visit [FPFV]) Not applicable")
RESULTS SUMMARY A Single Site, Open-Label Study to Evaluate the Immunogenicity and Safety of Influenza Vaccine () in Healthy Adults aged 18 to < 60 years and in Healthy Older Adults aged 60 years for the
10/6/2014. INFLUENZA: Why Should We Take The Vaccine? OUTLINE INFLUNZA VIRUS INFLUENZA VIRUS INFLUENZA VIRUS
INFLUENZA: Why Should We Take The Vaccine? Baptist Hospital Baptist Children s Hospital Doctors Hospital J. Milton Gaviria, MD, FACP October 17, 2014 Homestead Hospital Mariners Hospital Baptist Cardiac
Minnesota s Preparations for H1N1 Influenza. Sanne Magnan, MD, PhD Minnesota Department of Health September 23, 2009
Minnesota s Preparations for H1N1 Influenza Sanne Magnan, MD, PhD Minnesota Department of Health September 23, 2009 H1N1 Cases in Minnesota: Preliminary Data as of Sept. 21, 2009 281 hospitalized cases
BiondVax Pharmaceuticals Rating: Buy
Biotechnology Ashok Kumar, CFA 1-650-823-4745 akumar@aegiscap.com June 26, 2015 Key Metrics BVXV - NYSE $5.00 Pricing Date Jun 24 2015 Price Target $15.00 52-Week Range $5.42 - $3.81 Shares Outstanding
EMA guidelines on influenza vaccines
EMA guidelines on influenza vaccines High level hearing on the implementation of the Council Recommendation on seasonal influenza vaccination Presented by Manuela Mura on 30 April 2015 Scientific Officer
New Technology in Vaccine Engineering
Viruses in May Katoomba, August, 2012 New Technology in Vaccine Engineering Anton Middelberg Australian Institute for Bioengineering and Nanotechnology The University of Queensland, Australia Introduction
Safety and Immunogenicity of Multimeric-001 a Novel Universal Influenza Vaccine
J Clin Immunol (2012) 32:595 603 DOI 10.1007/s10875-011-9632-5 Safety and Immunogenicity of Multimeric-001 a Novel Universal Influenza Vaccine Jacob Atsmon & Efrat Kate-Ilovitz & Dimitry Shaikevich & Yossi
Influenza vaccines. Cheryl Cohen
Influenza vaccines Cheryl Cohen cherylc@nicd.ac.za Overview Burden of influenza and risk groups Clinical presentation, diagnosis and treatment Influenza the virus Currently available influenza vaccines
Draft Agreed by Immunologicals Working Party January Adoption by CVMP for release for consultation 12 March 2009
15 March 2010 EMA/CVMP/IWP/105506/2007 Committee for medicinal products for veterinary use (CVMP) Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza
ARIZONA INFLUENZA SUMMARY
ARIZONA INFLUENZA SUMMARY Week 4 (1/21/2018 1/27/2018) Synopsis: Influenza activity is elevated. Arizona reported Widespread Activity for week 4. Subscribe to the Flu & RSV report at azhealth.gov/email.
How flu vaccines work. Universal Influenza Vaccination of Children - the UK experience. 2 parts to an infection.. Direct effects.
Bristol Children s Vaccine Centre Universal Influenza Vaccination of Children - the UK experience @adamhfinn DIPS, Korsør 9 th November 018 How flu vaccines work Specific (on target) direct effects indirect
Seasonal Influenza Report
Key findings for the 2017 2018 flu season Seasonal Influenza Report 2017 2018 Influenza activity remains elevated throughout California. As of 2018 week 9 (February 25 March 3, 2018), the statewide geographic
Incorporating virologic data into seasonal and pandemic influenza vaccines
Incorporating virologic data into seasonal and pandemic influenza vaccines Kanta Subbarao WHO Collaborating Centre for Reference and Research on Influenza & Department of Microbiology and Immunology, University
GSK commitment to influenza prevention
GSK commitment to influenza prevention Dr Catia Ferreira Influenza Portfolio US Medical Affairs Leader GSK Vaccines GSK commitment to Influenza Rixensart (Belgium) Shenzhen (China) Marietta (US) Saint-Amand
Intercell and Novartis form world leading strategic partnership to drive vaccines innovation
Intercell and Novartis form world leading strategic partnership to drive vaccines innovation Alliance creates opportunity for two strong innovators to combine development efforts in attractive areas Intercell
The Universal Flu Vaccine
The Universal Flu Vaccine Multi-Season Multi-Strain Vaccine CORPORATE PRESENTATION Q4 2017 SAFE HARBOR STATEMENT 2 This presentation is not a prospectus or offer of securities for subscription or sale
Influenza-Associated Hospitalization and Death Surveillance: Dallas County
Influenza-Associated Hospitalization and Death Surveillance: Dallas County 2009 2015 Sonya Hughes, MPH, CPH Epidemiology Surveillance Coordinator July 22, 2015 Dallas County Health and Human Services Overview:
GSK s Candidate Influenza A (H5N1) Virus Monovalent Vaccine
GSK s Candidate Influenza A (H5N1) Virus Monovalent Vaccine Regulatory Pathway for Licensure VRBPAC, February 29, 2012 Katalin Abraham, Director, US Regulatory Affairs GSK Biologicals GSK s Influenza Vaccines
Alberta Health. Seasonal Influenza in Alberta. 2016/2017 Season. Analytics and Performance Reporting Branch
Alberta Health Seasonal Influenza in Alberta 2016/2017 Season Analytics and Performance Reporting Branch September 2017 For more information contact: Analytics and Performance Reporting Branch Health Standards,
Swine Flu Pandemic Weekly Report Thursday 20 August 2009
Key points Swine Flu Pandemic Weekly Report Thursday 20 August 2009 Levels of flu in Wales have decreased in the week ending 16 August. Current levels of flu in Wales are still higher than usual for this
Abstract: I. A ims Aim 1:
Abstract: Previous work from our laboratory demonstrated that obese mice have alterations in antiviral cytokine gene expression when infected with the influenza virus. Since these cytokines play a major
Adopted by CVMP 10 March Date for coming into effect 1 July Revised draft guideline agreed by Immunologicals Working Party 22 June 2017
1 2 3 7 September 2017 EMA/CVMP/IWP/105506/2007-Rev.1 Committee for medicinal products for veterinary use (CVMP) 4 5 6 7 Guideline on data requirements for multi-strain dossiers for inactivated vaccines
Weekly Influenza News 2016/17 Season. Communicable Disease Surveillance Unit. Summary of Influenza Activity in Toronto for Week 43
+ Weekly / Influenza News Week 43 (October 23 to October 29, 2016) Summary of Influenza Activity in Toronto for Week 43 Indicator (Click on the indicator Activity Level * Description name for more details)
Dengue: A disease burden in Sri Lanka A Complex Phase III Vaccine Trial
Dengue: A disease burden in Sri Lanka A Complex Phase III Vaccine Trial Country Overview Size: 65,610 sq km Population: 21,324,791 Population growth rate: 0.904% Population: Not genetically homogeneous
SAFETY, EFFICACY, AND USE OF INACTIVATED INFLUENZA VACCINE IN CHILDREN * Kathryn M. Edwards, MD RANDOMIZED TRIALS COMPARING INACTIVATED
SAFETY, EFFICACY, AND USE OF INACTIVATED INFLUENZA VACCINE IN CHILDREN * Kathryn M. Edwards, MD ABSTRACT A review of selected clinical trials of influenza vaccine shows that the vaccines are safe and effective
Novartis Vaccines and Diagnostics S.r.l
28 OCT 15 Page 1 of 11 Sponsor: Investigational Product: Indication: Protocol Number: Protocol Title: Phase of Development: and Diagnostics S.r.l ativ (Adjuvanted trivalent influenza virus vaccine (surface
Synthetic Genomics and Its Application to Viral Infectious Diseases. Timothy Stockwell (JCVI) David Wentworth (JCVI)
Synthetic Genomics and Its Application to Viral Infectious Diseases Timothy Stockwell (JCVI) David Wentworth (JCVI) Outline Using informatics to predict drift (strain selection) Synthetic Genomics: Preparedness
INFLUENZA IN MANITOBA 2010/2011 SEASON. Cases reported up to October 9, 2010
INFLUENZA IN MANITOBA 2/211 SEASON Cases reported up to October 9, 2 The public health disease surveillance system of Manitoba Health received its first laboratory-confirmed positive case of influenza
Alberta Health. Seasonal Influenza in Alberta Season Summary
Alberta Health Seasonal Influenza in Alberta 217 218 Season Summary September 218 Seasonal Influenza in Alberta, 217-218 Season Summary September 218 Suggested Citation: Government of Alberta. Seasonal
Global Challenges of Pandemic and Avian Influenza. 19 December 2006 Keiji Fukuda Global influenza Programme
Global Challenges of Pandemic and Avian Influenza 19 December 2006 Keiji Fukuda Global influenza Programme Summary of Current H5N1 Situation 1997 First known outbreak infecting humans 18 people hospitalized
1918 Influenza; Influenza A, H1N1. Basic agent information. Section I- Infectious Agent. Section II- Dissemination
1918 Influenza; Influenza A, H1N1 Basic agent information Section I- Infectious Agent Risk Group: - RG3 Synonym or Cross reference: - Spanish Flu - 1918 Flu - El Grippe Characteristics: - SELECT AGENT
BARDA INFLUENZA PROGRAM OVERVIEW
BARDA INFLUENZA PROGRAM OVERVIEW Drs. Armen Donabedian and Michael Wathen Vaccines and Therapeutics Resilient People. Healthy Communities. A Nation Prepared. 0 BARDA Overview 1 Perpetual challenge of responding
Fostering Clinical Development for HIV-1 Vaccine
W Fostering Clinical Development for HIV-1 Vaccine Ravimiarenduse alane seminar 9. oktoobril Tallinnas Mart Ustav, PhD CSO, SVP 1 FIT Biotech Founded in 1995 Operations in Tampere, Finland and Tartu, Estonia
Challenges in Development and Validation of an Intracellular Cytokine Staining assay
Challenges in Development and Validation of an Intracellular Cytokine Staining assay Jenny Hendriks, Crucell Hatching @ EBF, Brussels, June 202 www.crucell.com Vaccines vs Protein therapeutics Protein
Nova Scotia s Response to H1N1. Summary Report
Nova Scotia s Response to H1N1 Summary Report December 2010 H1N1 Summary Report l 1 Introduction In April 2009, an outbreak of a new virus called H1N1 influenza was identified in Veracruz, Mexico. As the
COPAXONE DEVELOPMENT AND STATE OF THE ART RUTH ARNON. The Weizmann Institute of Science Rehovot, ISRAEL
COPAXONE DEVELOPMENT AND STATE OF THE ART RUTH ARNON The Weizmann Institute of Science Rehovot, ISRAEL Research in academic institutions is mostly basic, namely curiosity-driven In some cases it reaches
Dengue: The next vaccine preventable disease? Prof John McBride James Cook University
Dengue: The next vaccine preventable disease? Prof John McBride James Cook University Dengue viruses A flavivirus ~11kb genome, ~50nm diameter, lipid envelope. Gene order 5 C-prM-E-NS1 Four serotypes (1-4)
Improving Influenza vaccines: Looking ahead
Improving Influenza vaccines: Looking ahead Gerd Sutter gerd.sutter@lmu.de ESWI Flu Summit - Brussels 30.09.2015 First 20th century pandemic - The Spanish Flu Courtesy: A. Garcia-Sastre Influenza A/CDC/1918
Influenza Surveillance Animal and Public Health Partnership. Jennifer Koeman Director, Producer and Public Health National Pork Board
Influenza Surveillance Animal and Public Health Partnership Jennifer Koeman Director, Producer and Public Health National Pork Board Outline Background on influenza surveillance in swine Case example animal
The humoral immune responses to IBV proteins.
The humoral immune responses to IBV proteins. E. Dan Heller and Rosa Meir The Hebrew University of Jerusalem, Israel COST FA1207 meeting WG2 + WG3, Budapest, Jan. 2015 1 IBV encodes four major structural
The Universal Flu Vaccine
The Universal Flu Vaccine Multi-Season Multi-Strain Vaccine CORPORATE PRESENTATION Q4 2017 SAFE HARBOR STATEMENT 2 This presentation is not a prospectus or offer of securities for subscription or sale
Gene Vaccine Dr. Sina Soleimani
Gene Vaccine Dr. Sina Soleimani Human Viral Vaccines Quality Control Laboratory (HVVQC) Titles 1. A short Introduction of Vaccine History 2. First Lineage of Vaccines 3. Second Lineage of Vaccines 3. New
Detection of neuraminidase-inhibiting antibodies for measurement of Influenza vaccine immunogenicity
Borgis New Med 2015; 19(4): 147-155 DOI: 10.5604/14270994.1191796 Detection of neuraminidase-inhibiting antibodies for measurement of Influenza vaccine immunogenicity *Mónika Rózsa 1, István Jankovics
Immunization Update 2018
Immunization Update 2018 Keri Hurley-Kim, PharmD, MPH Assistant Professor, Department of Pharmacy Practice West Coast University School of Pharmacy Conflicts of Interest Keri Hurley-Kim declares no conflicts