sp second generation tetravalent dengue vaccine
|
|
- Clara Bridget Patterson
- 5 years ago
- Views:
Transcription
1 sp second generation tetravalent dengue vaccine CYD23 Study Efficacy and Safety of Dengue Vaccine in Healthy Children Aged 4 to 1 Years in Thailand Alain Bouckenooghe, MD, MPH, DTM&H Clinical R&D, Head Asia/Pacific region JITMM meeting, Bangkok, Thailand, Oct 28
2 Dengue Mosquito-borne flaviviral infection Dengue is present in more than 124 countries and territories More than 2.5 billion persons live in endemic regions (intertropical areas) Every year: 7 to 1 million infected persons Estimated over 2 million severe forms (among which 9 % are children) Approximately 21 deaths 2 There is no specific treatment and the care of the disease is based on symptomatic treatment A Dengue vaccine represents a Public Health priority
3 Impact of vaccination coverage on incidence of DHF/DSS cases 9 8 No vaccination Vaccination coverage 7% Base case 7 Incidence (/1) Year Vaccination alters disease dynamics by reducing the frequency and intensity of years with peak dengue incidence 3
4 Current Dengue Vaccine Developments Butantan NIH licensee Biological E. NIH licensee Panacea NIH licensee Fiocruz Chimeric Hawaii Biotech/NIH/ WRAIR/GSK Subunit Inviragen/CDC/Sha ntha Live attenuated DEN/DEN Chimeric NMRC/WRAIR DNA vaccine (monovalent) Sanofi pasteur Chimeric Live attenuated WRAIR/Crucell Whole virus inactivated NIH/Univ. Of Maryland DEN/DEN Chimeric GSK/WRAIR Live attenuated Preclinical Phase I Phase II Phase III 4
5 sanofi pasteur second generation Tetravalent dengue vaccine candidate Live attenuated dengue vaccines expressing the pre-membrane (prm) and envelope (E) proteins of each dengue serotype, which genes have been inserted in place of the corresponding genes of the YF 17D vaccine prm E 1 5 C NS1 2A 2B NS3 4A 4B NS The surface phenotype of these vaccines is thus no longer a YF-17D one, and their tropism is first linked to their dengue envelope Envelope is the immunizing Ag from an heterologous virus RNA replication engine is from YF17D 5
6 Three phase II observer-blind randomized controlled trials Study: Population FV Immune status at baseline** Protocol Group 1: Group 2: Objective USA 66 Adults 18-4yr 3% 18 Adults 18-45yr 36 Adolescents 12-17yr 72 Children 2-11yr 18 Adults 18-45yr 36 Adolescents 12-17yr 72 Children 2-11yr injections DV or control: Months, 3-4, DV*, DV, DV Placebo, DV, DV Philippines 8% DV, DV, DV TyphimVi, DV, DV Mexico 8% DV, DV, DV Stamaril, DV, DV To describe: safety, viremia and humoral immune responses, after each vaccine injection *DV= Dengue Vaccine **based on neut antibodies (dengue and JE for the Philippines) 6
7 Recent Proof of concept established in flavirivus-naive adult US subjects with this tetravalent vaccine GMT IgM GMT 1 GMT IgG 1 8 1/dil Pre-D1 Post-D1 Pre-D2 Post-D2 Pre-D3 Post-D Serotype 1 Serotype 2 Serotype 3 Serotype 4 Dengue Vaccine Tetravalent evaluation in US Flavivirus negative Adults 1 Seroconversion* for 4 types, with robust titers after 3 doses Satisfactory safety profile *Dengue 5% Plaque reduction neutralization titer (seropositivity > 1:1) for each of the four serotypes for two different laboratory strains - data from the WHO Laboratory Reference Center, Mahidol University Thailand % seroconversion (>=1) Safety Dengue vaccine Placebo % % Serotype 1 Serotype 2 Serotype 3 Serotype 4 All 4 serotypes 2 Any adverse Injection site Systemic 7
8 Mexico (Non Endemic Country) - Reactogenicity after each dose of dengue vaccine in grp 1 (DV - 3 doses) (all subjects) No SAE after the 3rd dose 1 8 DV-Dose 1 (n=84) DV-Dose 2 (n=79) % subjects Any AE Any Reaction Inj site Systemic DV-Dose 3 (n=73) Sev inj site Sev syst Trend for a decrease of some systemic s after a 2nd and 3rd dose (headache, malaise, myalgia) Injection site pain tends to be more frequent after a 3rd dose (especially in adults) but s are mild and transient (<=3 days) % subjects DV-Dose 1 (n=84) DV-Dose 2 (n=79) DV-Dose 3 (n=73) 1 Headache M alaise M yalgia Asthenia Pyrexia Inj site pain Inj site erythema Inj site oedema 8
9 Philippines (Endemic Country) - Reactogenicity after each dose of dengue vaccine in grp 1 (DV 3 doses) (all subjects) 1 No SAE after the 3rd dose % subjects DV-Dose 1 (n=84) DV-Dose 2 (n=82) DV-Dose 3 (n=8) 6 Any AE Any Reaction Inj site Systemic Sev inj site Sev syst Trend for a decrease of s (both injection site & systemic s) after a 2 nd and 3 rd dose % subjects DV-Dose 1 (n=84) DV-Dose 2 (n=82) DV-Dose 3 (n=8) 1 Headache M alaise M yalgia Asthenia Pyrexia Inj site pain Inj site erythema 9 Inj site oedema
10 CYD5(Philippines)/CYD6 Mexico)Trials % of seropositive subjects against at least 3 serotypes after each injection all subjects CYD5 - % Seropositivity (95% CI) - >= 3 serotypes 1 8 Grp 1 - DV 3 doses #REF! % Subjects Pre-Vacc 1 Post-Vacc 1 Post-Vacc 2 Post-Vacc 3 Three doses of DV with the schedule, 3, 12 months induce a good immune response in a naïve and nonnaïve population CYD6 - % Seropositivity (95% CI) - >= 3 Serotypes 1 8 Grp 1 - DV 3 doses % Subjects Post-Vacc 1 Post-Vacc 2 Post-Vacc 3 1
11 From phase II trials to phase III trials Phase II trials Safety and Immunogenicity (S&I) CYD22 S&I Adults-ado Children JE+/-, Den+/- Vietnam CYD28 S&I Child-Ado-Adults Den+/- Singapore CYD12 S&I Adults FV naive US CYD13 S&I Adolescents Den+/- Latin Am CYD24 S&I Children YF+, Den+/- Peru CYD23 POC -Efficacy Children JE+/-, Den+/- Thailand Phase III trials Large Scale S&I Co-administration study Efficacy trial Lot to lot consistency 11
12 3 POC efficacy trial (CYD23, Thailand) Trial Design Choice of Ratchaburi province: PDVI cohort High dengue incidence average: 1.4 % in children Long-lasting collaboration with a team at Mahidol University* Observer-blind study Principal Investigator : Pr Arunee Sabchareon 42 children from 4 to 11 years old at time of inclusion:1/3 control vaccine (rabbies vaccine Verorab); 2/3 dengue vaccine Vaccination period : 3 sub-cutaneous injections at D, D + 6 months, D + 12 months, with a two-step approach for the first vaccination: * Faculty of Tropical Medecine and Center for Vaccine Development (Mahidol University) 12
13 Trial Design Population Group 1 (Dengue Vaccine Group) Group 2 (Control Group Verorab) TOTAL Children: 4-1 years
14 Objectives: Primary To assess the efficacy of dengue vaccine after three injections in preventing symptomatic virologically* confirmed dengue cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 1 years at the time of inclusion * According to WHO Guidelines for the evaluation of dengue vaccines in populations exposed to natural infection. TDR/IVR/DEN/1 14
15 Objectives: Secondary (All subjects) Efficacy To assess the efficacy of dengue vaccine in children aged 4 to 1 years at the time of inclusion in: Preventing severe virologically-confirmed dengue cases due to any of the four serotypes Preventing symptomatic dengue cases, either virologically-confirmed or probable based on serological criteria, due to any of the four serotypes These evaluations will be performed in subjects having received at least two injections having received three injections of dengue vaccine Safety To evaluate the occurrence of SAEs in all subjects throughout the trial period 15
16 Flow Chart (All subjects) Efficacy Evaluation D 6M 12M 12M +3d 24M 48M ICF Inclusion/Exclusion Criteria 3 Minute observation period Blood sample / Efficacy Evaluation 16
17 Flow Chart (Subgroup) Reactogenicity, Immunogenicity, Viremia D D8 D15 D28 6M 6M+ 6M+ 6M+ 12M 12M+ 8D 15D 28D 3d 12M+ +12M 12M+ +24M 12M+ +36M ICF Inclusion/Exclusion Criteria Reactogenicity: 15 subjects Immunogenicity: 3 subjects Viremia / Biological safety: 1 subjects 17
18 Trial Design Follow-up of dengue cases Months Detection of Dengue cases: 12 months after the third injection 27 cases Additional follow-up: hospitalized cases Active detection -school absenteism during school terms -weekly phone call/home visits during holiday periods Passive detection -parents/guardians asked to spontaneously bring their child to the RRH in case of febrile illness 18
19 Dengue Asia IDMC members Pr. Kim Mulholland (Chairman) Pr. Siripen Kalayanarooj Dr.Tran Tinh Hien Pr. Quak Seng Hock Pr. Peter Smith Mr Jukka Jokinen, PhD (Expert statistician) 19
Dengue Vaccines: current status of development
Dengue Vaccines: current status of development ISID-NTD 2011 International Meeting, Boston Satellite Symposium on Dengue Control, 10 July 2011 Pem Namgyal WHO/IVB/IVR 1 Presentation Outline! Summary of
More informationMaking Dengue a Vaccine Preventable Disease
Making Dengue a Vaccine Preventable Disease Harold S. Margolis, MD, FAAP Joint International Tropical Medicine Meeting (JITMM) Bangkok, Thailand October 13, 2008 Dengue Vaccines Where are We Today? No
More informationDengue Vaccine Butantan Institute. DCVMN, Bangkok, 2015
Dengue Vaccine Butantan Institute DCVMN, Bangkok, 2015 GENOME Dengue Viruses Dengue is a mosquito-borne RNA virus with 4 distinct serotypes: 1,2,3,and 4 3 structural proteins: C, prm, and E E protein is
More informationFlavivirus Vaccines Japanese Encephalitis and Dengue
Flavivirus Vaccines Japanese Encephalitis and Dengue 14 th Advanced Vaccinology Course Veyrier du Lac, France May 16, 2012 Harold S. Margolis, MD Dengue Branch Centers for Disease Control and Prevention
More informationDengue and Zika vaccine development
Dengue and Zika vaccine development Carolyn E. Clark, PhD, MPH Scientist, Infection Control and Environmental Health Norwegian Institute of Public Health Kurs i import- og reisemedisin for helsepersonell
More informationA Recombinant Tetravalent Dengue Vaccine Candidate Using DENV-2 Backbone
A Recombinant Tetravalent Dengue Vaccine Candidate Using DENV-2 Backbone First Regional Dengue Symposium, Rio de Janeiro, Brazil Nov 3-4 2015 Pedro Garbes, MD. Regional Medical Director, Latin America.
More informationPre-clinical Development of a Dengue Vaccine. Jeremy Brett Sanofi Pasteur, Singapore
Pre-clinical Development of a Dengue Vaccine Jeremy Brett Sanofi Pasteur, Singapore Dengue Vaccine B Guy 1 Talk flow Introduction: What are the challenges of dengue vaccine development? The Virus The host
More informationResults of Phase III Efficacy Studies in Dengue Endemic Regions of the Sanofi Pasteur Candidate Dengue Vaccine
Results of Phase III Efficacy Studies in Dengue Endemic Regions of the Sanofi Pasteur Candidate Dengue Vaccine Maria Rosario Z. Capeding, MD Research Institute for Tropical Medicine Philippines From
More informationLEADING DENGUE VACCINE CANDIDATE COULD CHANGE THE LIVES OF MILLIONS
FACT SHEET LEADING DENGUE VACCINE CANDIDATE COULD CHANGE THE LIVES OF MILLIONS A GLOBAL PUBLIC HEALTH CHALLENGE Dengue fever, a mosquito-borne disease caused by four types of dengue viruses, is a threat
More informationImmune protection against dengue infection. Vaccine performance
Immune protection against dengue infection. Vaccine performance SCOTT B HALSTEAD MD Department of Preventive Medicine Uniformed Services University of the Health Sciences TOPICS Current dengue vaccines:
More informationThe Pediatric Dengue Vaccine Initiative (PDVI) Thailand, 2007
The Pediatric Dengue Vaccine Initiative (PDVI) Thailand, 2007 The Vaccine Enterprise-the the disease Clinical data Surveillance data Laboratory data/diagnostics Input, analysis and reporting The Vaccine
More informationDengue: 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)
More informationDengue Vaccine. Irani Ratnam The Royal Melbourne Hospital & Peter Doherty Institute
Dengue Vaccine Irani Ratnam The Royal Melbourne Hospital & Peter Doherty Institute No Conflicts of interest Dengue Dengue virus (DENV), a member of the genus Flavivirus Vector-borne disease transmitted
More informationDengue Vaccines: Status and Future
Dengue Vaccines: Status and Future In-Kyu Yoon, M.D. International Vaccine Institute Director, Global Dengue & Aedes-Transmitted Diseases Consortium 22 Jun 2018 Outline Tetravalent vaccination strategy
More informationPublic Assessment Report for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No1901/2006, as amended
Public Assessment Report for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No1901/2006, as amended < Typhim Vi > AT/W/0017/pdWS/001-002 Marketing
More informationFive-Year Antibody Persistence Following A Booster Dose of Live- Attenuated Japanese Encephalitis Vaccine (IMOJEV ) in Children
Five-Year Antibody Persistence Following A Booster Dose of Live- Attenuated Japanese Encephalitis Vaccine (IMOJEV ) in Children Chansinghakul Danaya, MD 1 ; Feroldi Emmanuel, MD 2 ; Capeding Maria R, MD
More informationMODULE 5. Dengue. Edwin J. Asturias Associate Professor of Pediatrics Senior Investigator Director for Latin America
MODULE 5 Dengue Edwin J. Asturias Associate Professor of Pediatrics Senior Investigator Director for Latin America Symptoms of Dengue Fever Dengue: Skin rashes DHF manifestations Hemorrhages Thrombocytopenia
More informationLong-term Immunogenicity Following Vaccination with a New, Live-attenuated Vaccine Against Japanese Encephalitis (JE-CV)
Long-term Immunogenicity Following Vaccination with a New, Live-attenuated Vaccine Against Japanese Encephalitis (JE-CV) Sutee Yoksan, M.D., Ph.D. Center for Vaccine Development, Mahidol University Joint
More informationDengue vaccine โดย ศ. พญ. ก ลก ญญา โชคไพบ ลย ก จ ภาคว ชาก มารเวชศาสตร คณะแพทยศาสตร ศ ร ราชพยาบาล
Dengue vaccine โดย ศ. พญ. ก ลก ญญา โชคไพบ ลย ก จ ภาคว ชาก มารเวชศาสตร คณะแพทยศาสตร ศ ร ราชพยาบาล SANOFI PASTEUR S DENGUE VACCINE*: THE MOST CLINICALLY ADVANCED DENGUE VACCINE CANDIDATE There are 4 genetic
More informationSummary of Key Points WHO Position Paper on Dengue Vaccine, September 2018
Summary of Key Points WHO Position Paper on Dengue Vaccine, September 2018 For more information on the WHO Dengue position paper, please visit the WHO website: www.who.int/immunization/documents/positionpapers
More informationCYD-TDV Dengvaxia clinical update
Chris Nelson Sanofi Pasteur CYD-TDV Dengvaxia clinical update "Arboviruses: A Global Public Health Threat" 20-22 June 2018 Les Pensières Center for Global Health, Veyrier-du-Lac (France) JUNE 2018 1 The
More informationImpact of Dengue Vaccination on Serological Diagnosis: Insights From Phase III Dengue Vaccine Efficacy Trials
Clinical Infectious Diseases MAJOR ARTICLE Impact of Dengue Vaccination on Serological Diagnosis: Insights From Phase III Dengue Vaccine Efficacy Trials Eric Plennevaux, 1 Annick Moureau, 2 José L. Arredondo-García,
More informationDengue Experience and Implications for Vaccine Development
Dengue Experience and Implications for Vaccine Development In-Kyu Yoon, M.D. International Vaccine Institute Director, Global Dengue & Aedes-Transmitted Diseases Consortium 28 Jun 2018 Mission: To promote
More informationThe primary vaccination schedule consists of 3 injections of one reconstituted dose (0.5 ml) to be administered at 6-month intervals.
1 NAME OF THE MEDICINAL PRODUCT Dengvaxia, powder and solvent for suspension for injection. Dengue tetravalent vaccine (live, attenuated). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution,
More informationMathematical Models for the Control of Infectious Diseases With Vaccines
Mathematical Models for the Control of Infectious Diseases With Vaccines Ira Longini Department of Biostatistics and Center for Statistical and Quantitative Infectious Diseases (CSQUID), University of
More informationImmunogenicity and safety of recombinant tetravalent dengue vaccine (CYD-TDV) in individuals aged 2 45 years
Human Vaccines & Immunotherapeutics ISSN: 2164-5515 (Print) 2164-554X (Online) Journal homepage: https://www.tandfonline.com/loi/khvi2 Immunogenicity and safety of recombinant tetravalent dengue vaccine
More informationLecture 9: Stochastic models for arboviruses. Ira Longini
Lecture 9: Stochastic models for arboviruses Ira Longini The Ross-MacDonald Model for Vector Bourne Infectious Diseases Sir Ronald Ross (1857-1932) Liverpool School of Tropical Medicine The 2 nd Nobel
More informationDevelopment of Recombinant Pertussis Vaccines
Development of Recombinant Pertussis Vaccines Wassana Wijagkanalan, PhD BioNet-Asia Co., Ltd, Bangkok, Thailand DCVMN Workshop: Global Registration and Vaccine Shortage 6-10 March 2017, Taipei, Taiwan
More informationUpdated Questions and Answers related to the dengue vaccine Dengvaxia and its use
WHO Secretariat Updated Questions and Answers related to the dengue vaccine Dengvaxia and its use Published 22 December 2017 This document takes into account new and unpublished data that were communicated
More informationDengue Vaccine (CYD-TDV Dengvaxia )
Dengue Vaccine (CYD-TDV Dengvaxia ) Annelies Wilder-Smith Consultant, Vaccines for Arboviral Diseases, WHO-IVB Lee Kong Chian School of Medicine, Singapore Director, Partnership for Dengue Control, Fondation
More informationUpdate on the NIH tetravalent dengue vaccine. Beulah Sabundayo, PharmD, MPH Johns Hopkins Bloomberg School of Public Health
Update on the NIH tetravalent dengue vaccine Beulah Sabundayo, PharmD, MPH Johns Hopkins Bloomberg School of Public Health 1 Tetravalent studies in DENV naïve adults Potency (log Vaccine Components: 10
More informationTowards Dengue Vaccine Introduction:! Report of the Asia-Pacific Dengue Prevention Board Meeting
Towards Dengue Vaccine Introduction:! Report of the Asia-Pacific Dengue Prevention Board Meeting Sri Rezeki S Hadinegoro Department of Child Health Medical Faculty University of Indonesia Lay out Introduction
More informationTel:
A/Prof Joe Torresi Department of Infectious Diseases Austin Hospital Austin Centre for Infection Research Department of Medicine (Austin Health) The University of Melbourne Tel: 61 3 9496 6676 josepht@unimelb.edu.au
More informationCanadian Immunization Conference 2018 Dec 4
Enveloped Virus-Like Particle (evlp) Cytomegalovirus (CMV) Vaccine is immunogenic and safe: preliminary results of a First-in-Humans Canadian Immunization Network (CIRN) Clinical Trials Network (CTN) -
More informationJapanese Encephalitis: Prevention Through Vaccination. Jaime A. Santos
Japanese Encephalitis: Prevention Through Vaccination Jaime A. Santos Outline Introduction: Epidemiology, Disease and Sequelae Prevention: Role of Vaccination Vaccines against JE; SP Chimeric Vaccine Conclusions
More informationSAGE Working Group on Yellow Fever Vaccine: Interference between YF vaccine and other vaccines 11 January 2012
Search was done to identify published and soft literature (not peer-reviewed but available through the web or other sources like books) using the following resources: PubMed, Scirus, ScienceDirect, references
More informationESCMID Online Lecture Library. by author
Update and Prospects for CMV Vaccine Robert Pass University of Alabama at Birmingham ESCMID Postgraduate Course Centro Universitario Residenziale di Bertinoro 29 Sept 29 3 Oct 2013 Disclosures: Partial
More informationDevelopment of a Recombinant Subunit Dengue Vaccine. Flavivirus Vaccination Fondation Mérieux December 8, 2010 Beth-Ann Coller
Development of a Recombinant Subunit Dengue Vaccine Flavivirus Vaccination Fondation Mérieux December 8, 2010 Beth-Ann Coller Recombinant Subunit Dengue Vaccine Recombinant Envelope Protein Vaccine Hawaii
More informationBACKGROUND PAPER ON DENGUE VACCINES
BACKGROUND PAPER ON DENGUE VACCINES REVISION TO THE BACKGROUND PAPER FROM 17 MARCH 2016 PREPARED BY THE SAGE WORKING GROUP ON DENGUE VACCINES AND WHO SECRETARIAT 18 APRIL 2018 1 TABLE OF CONTENTS 1. Executive
More informationProposal for a Workshop
Proposal for a Workshop Pre-vaccination screening for the use of dengue vaccines with differential performance dependent on serostatus: rapid diagnostic tests and implementation strategies Background:
More informationDENGUE AND BLOOD SAFETY. Ester C Sabino, MD, PhD Dep. of Infectious Disease/Institute of Tropical Medicine University of São Paulo
DENGUE AND BLOOD SAFETY Ester C Sabino, MD, PhD Dep. of Infectious Disease/Institute of Tropical Medicine University of São Paulo Dengue virus Arbovirus (arthropod-borne virus) virus transmitted by mosquitoes:
More informationExchange Program. Thailand. Mahidol University. Mahidol-Osaka Center for Infectious Diseases (MOCID) Date: 2013/06/05~2013/07/04
Exchange Program Thailand Mahidol University Mahidol-Osaka Center for Infectious Diseases (MOCID) Date: 2013/06/05~2013/07/04 Kobe University School of Medicine Faculty of Health Science Ueda Shuhei Introduction
More informationRole of a ZIKV CHIM in vaccine evaluation. Anna Durbin Johns Hopkins Bloomberg School of Public Health WHO Zika Workshop, Geneva 2 June 2017
Role of a ZIKV CHIM in vaccine evaluation Anna Durbin Johns Hopkins Bloomberg School of Public Health WHO Zika Workshop, Geneva 2 June 2017 1 ZIKV congenital syndrome There is increasing evidence from
More informationTAKEDA VACCINES INNOVATION FOR GLOBAL IMPACT. RAJEEV VENKAYYA, MD President, Global Vaccine Business Unit
TAKEDA VACCINES INNOVATION FOR GLOBAL IMPACT RAJEEV VENKAYYA, MD President, Global Vaccine Business Unit OUR MISSION Develop and deliver innovative vaccines that tackle the toughest problems in public
More informationNew epidemiological perspectives coming from dengue vaccine clinical trials. João Bosco Siqueira Jr Federal University of Goias - Brazil
New epidemiological perspectives coming from dengue vaccine clinical trials João Bosco Siqueira Jr Federal University of Goias - Brazil Dengue Key Facts The global incidence of dengue has grown dramatically
More informationVaccine prevention for existing and emerging viral threats
Vaccine prevention for existing and emerging viral threats Viruses in May Blue Mountains 18 May 2018 www.ncirs.edu.au https://www.apprise.org.au/ Prof Kristine Macartney Director, NCIRS www.ncirs.usyd.edu.au
More informationALVAC -HIV and AIDSVAX B/E Prime-Boost HIV-1 Preventive Vaccine Regimen. Results of the Thai HIV Vaccine Trial, RV144
ALVAC -HIV and AIDSVAX B/E Prime-Boost HIV-1 Preventive Vaccine Regimen Results of the Thai HIV Vaccine Trial, RV144 SupachaiRerks-Ngarm, PunneePittisutthithum, SorachaiNitayaphan, JaranitKaewkungwal,
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: 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.
More informationDeveloping a dengue vaccine: progress and future challenges
Ann. N.Y. Acad. Sci. ISSN 0077-8923 ANNALS OF THE NEW YORK ACADEMY OF SCIENCES Issue: Antimicrobial Therapeutics Reviews Developing a dengue vaccine: progress and future challenges Stephen J. Thomas Walter
More informationMeeting of the WHO Task Force on Clinical Trials of Dengue Vaccines
VWHO/IVB/07.11 ORIGINAL: ENGLISH Meeting of the WHO Task Force on Clinical Trials of Dengue Vaccines Atlanta, GA, USA 11 November 2006 Immunization, Vaccines and Biologicals I V BMeeting WHO/IVB/07.11
More informationDevelopment and Application of a Novel Attenuated Live Japanese Encephalitis Vaccine SA
Development and Application of a Novel Attenuated Live Japanese Encephalitis Vaccine SA14-14-2 Yu Yongxin (National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050,
More informationSafety and Immunogenicity of a Parenterally Administered Rotavirus VP8 Subunit Vaccine in Healthy Adults
Safety and Immunogenicity of a Parenterally Administered Rotavirus VP8 Subunit Vaccine in Healthy Adults Stanley Cryz 1, Clayton Harro 2, Monica McNeal 3, Nicole Meyer 3, Barbara DeNearing 2, Alicia Cage
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: 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.
More informationDengue vaccine: WHO position paper July 2016
Dengue vaccine: WHO position paper July 2016 References with abstracts cited in the position paper in the order of appearance. World Health Organization. Global Strategy for dengue prevention and control,
More informationJoseph E. Blaney, Jr.,* Jennifer M. Matro, Brian R. Murphy, and Stephen S. Whitehead
JOURNAL OF VIROLOGY, May 2005, p. 5516 5528 Vol. 79, No. 9 0022-538X/05/$08.00 0 doi:10.1128/jvi.79.9.5516 5528.2005 Recombinant, Live-Attenuated Tetravalent Dengue Virus Vaccine Formulations Induce a
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: 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.
More informationLong-term follow-up at Month 198: 21 October 2008 to 07 December Long-term follow-up at Month 186: 01 October 2007 to 19 December 2008
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.
More informationHigh Dose Inactivated Influenza Vaccines. Robert L. Atmar, M.D. Baylor College of Medicine WHO Meeting January 2013
High Dose Inactivated Influenza Vaccines Robert L. Atmar, M.D. Baylor College of Medicine WHO Meeting January 2013 Increased (High) Dose IVV A Brief History Dose response for immunogenicity & injection
More informationHIV 1 Preventive Vaccine Regimen. Community based Trial in Thailand V 144. for the MOPH TAVEG Collaboration
V ALVAC HIV and AIDSVAX B/E Prime Boost HIV 1 Preventive Vaccine Regimen Final Results of the Phase III Community based Trial in Thailand Supachai Rerks Ngarm, Punnee Pittisutthithum, Sorachai Nitayaphan,
More informationDengue Vaccines Mahidol
We have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with dengue vaccines mahidol.
More informationWHO Working Group on Technical Specifications for Manufacture and Evaluation of Dengue Vaccines
Distribution: General English only Meeting Report WHO Working Group on Technical Specifications for Manufacture and Evaluation of Dengue Vaccines Geneva, Switzerland 11-12 May 2009 1 1 Disclaimer: This
More informationEmerging TTIs How Singapore secure its blood supply
Emerging TTIs How Singapore secure its blood supply Ms Sally Lam Acting Division Director I Blood Supply Management I Blood Services Group I Health Sciences Outline Risk Mitigation Strategies to secure
More informationFlaviviruses New Challenges, New Vaccines
Flaviviruses New Challenges, New Vaccines Christian W. Mandl Institute of Virology Medical University of Vienna, AUSTRIA Family Flaviviridae Genus Hepacivirus Genus Pestivirus Genus Flavivirus (>70 members)
More informationOverview of a neglected infectious disease: dengue
Overview of a neglected infectious disease: dengue Outline Current epidemiological trends Mechanisms underlying dengue transmission Dengue control Overview of recent modeling efforts Drivers of serotype
More informationPERSPECTIVES IN THE DEVELOPMENT OF VACCINES AGAINST FLAVIVIRUSES. M. Rossman. Thomas P Monath MD
PERSPECTIVES IN THE DEVELOPMENT OF VACCINES AGAINST FLAVIVIRUSES M. Rossman Thomas P Monath MD Agenda State of the art of flavivirus vaccines Second generation vaccines Rational design, balancing attenuation
More informationEvidence review on the immunogenicity, efficacy/effectiveness and safety of typhoid conjugate vaccines
Evidence review on the immunogenicity, efficacy/effectiveness and safety of typhoid conjugate vaccines SAGE meeting, Geneva, 17-19 October, 2017 Myron M. (Mike) Levine, MD, DTPH Grollman Distinguished
More informationGlobal Perspectives on Dengue Research
By Scott B. Halstead Adjunct Professor, Department of Preventive Medicine, Uniformed Services, University of the Health Sciences, Bethesda, MD, USA Abstract Dengue viruses infect nearly 100 million human
More informationReview of the evidence: Vaccine immunogenicity, effec7veness, and impact
Review of the evidence: Vaccine immunogenicity, effec7veness, and impact Susan Hills MBBS, MTH Division of Vector- Borne Diseases Centers for Disease Control and Preven7on, Colorado, USA Outline q Inactivated
More informationCorrelates of Protection in Dengue. Stephen J. Thomas, MD Division of Infectious Diseases State University of New York Upstate Medical University
Correlates of Protection in Dengue Stephen J. Thomas, MD Division of Infectious Diseases State University of New York Upstate Medical University May 2017 Discussion of correlates requires clarity and proper
More informationWhat is the role of animal models in studying protective titres and the need for establishing surrogates/correlates of protection?
What is the role of animal models in studying protective titres and the need for establishing surrogates/correlates of protection? Alan D.T. Barrett Department of Pathology and Sealy Center for Vaccine
More informationStudy 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.
More informationSymptomatic Dengue in Children in 10 Asian and Latin American Countries
The new england journal of medicine Original Article Symptomatic Dengue in Children in 10 Asian and Latin American Countries Maïna L Azou, M.Sc., Annick Moureau, M.Sc., Elsa Sarti, Ph.D., Joshua Nealon,
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: 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.
More informationImmunogenicity and Safety of GSK s FluLaval Quadrivalent Inactivated Influenza Vaccine in Children 6-35 Months of Age
Immunogenicity and Safety of GSK s FluLaval Quadrivalent Inactivated Influenza Vaccine in Children 6-35 Months of Age Bruce L Innis, MD, FIDSA GSK Vaccines Inactivated Influenza Vaccines for 6-35 Months
More informationGSK Medication: Study No.: 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.
More informationNASRONUDIN 4/17/2013. DENVs of each type are grouped into several genotypes.
NASRONUDIN Institute of Tropical Disease, Airlangga University-Tropical and Infectious Diseases Division, Department of Internal Medicine Medical Faculty-Dr. Soetomo Hospital Disampaikan pada 14 th Jakarta
More informationRegulatory Considerations for Determining Vaccine Efficacy U.S. FDA Perspective
Regulatory Considerations for Determining Vaccine Efficacy U.S. FDA Perspective Marion Gruber, PhD. Director Office of Vaccines Research & Review Center for Biologics Evaluation and Research Food and Drug
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: 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.
More informationEPIDEMIOLOGICAL STUDIES
EPIDEMIOLOGICAL STUDIES EPIDEMIOLOGIC STUDIES EPIDEMIOLOGIC STUDIES 8 Clinical Trial sites in Brasil (NICHD) Transfusion recipient study (NHLBI) Prospective study in Brasil (Yale) Natural history population
More informationPreclinical and Clinical Development of a YFV 17 D-Based Chimeric Vaccine against West Nile Virus
Viruses 2013, 5, 3048-3070; doi:10.3390/v5123048 Review OPEN ACCESS viruses ISSN 1999-4915 www.mdpi.com/journal/viruses Preclinical and Clinical Development of a YFV 17 D-Based Chimeric Vaccine against
More informationThe scope of the Zika pandemic and implications for vaccine development
The scope of the Zika pandemic and implications for vaccine development Jon Heinrichs, Ph.D. Associate Vice President & Segment Head Early and Pre-Development Projects Zika Vaccine Project Leader Emergence
More informationModeling results / SDF: Routine vaccination strategy Introduction catch-up strategy
Modeling results / SDF: Routine vaccination strategy Introduction catch-up strategy Ira Longini, Diana Rojas, Tom Hladish CSQUID, University of Florida, Gainesville, FL Betz Halloran, Dennis Chao Fred
More informationPEDIATRIC INFECTIOUS DISEASE SOCIETY OF THE PHILIPPINES, INC.
RESPONSE FROM THE PEDIATRIC INFECTIOUS DISEASE SOCIETY OF THE PHILIPPPINES REGARDING CURRENT ISSUES ON THE USE OF THE DENGUE VACCINE 12 December 2017 In December 2015, the Philippines licensed the first
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: 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.
More informationZika virus: laboratory diagnosis
Zika virus: laboratory diagnosis Dr Linda Hueston Principal Scientist Arbovirus Emerging Diseases Unit CIDMLS-ICPMR Westmead Hospital Linda.Hueston@health.nsw.gov.au Laboratory Diagnosis Flaviviruses >70
More informationDOI: /ICJ (Dengue fever) [2] (Aedes aegypti) (Aedes albopictus) (Dengue. (Flavivirus) 50 nm. ssrna) (capsid, C) ( ) (membrane, prm/m)
210 DOI: 10.6526/ICJ.2016.504 T (Dengue fever) [1] 128 39 [2] 4 5 21,000 [3] 3 1981 1987 1995 2014 [4] 2015 ( ) (Aedes aegypti) (Aedes albopictus) (Dengue virus) (Flaviviridae) (Flavivirus) 50 nm 11 kb
More informationThe Immunogenicity and Safety of CYD-Tetravalent Dengue Vaccine (CYD-TDV) in Children and Adolescents: A Systematic Review
ORIGINAL ARTICLE The Immunogenicity and Safety of CYD-Tetravalent Dengue Vaccine (CYD-TDV) in Children and Adolescents: A Systematic Review Raksheeth Agarwal 1, Mardiastuti H. Wahid 2, Oliver E. Yausep
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
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.
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: 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.
More informationA Short History of Dengue and Mahidol Dengue
A Short History of Dengue and Mahidol Dengue Vaccine Sutee Yoksan Center for Vaccine Development, Institute of Molecular Biosciences, Mahidol University, Phutthamonthon, Nakhon Pathom, Thailand Abstract.
More informationEdwin J. Asturias Associate Director
Edwin J. Asturias Associate Director Center for Global Health Associate Professor of Pediatrics and Epidemiology Effectiveness Dengue Vaccine Washington DC, June 2014 UNIVERSITY OF COLORADO COLORADO STATE
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: 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.
More informationCan we improve the performance of live oral rotavirus vaccines?
Can we improve the performance of live oral rotavirus vaccines? Duncan Steele 9 th International Rotavirus Symposium 2 & 3 August 2010, Johannesburg, South Africa Vaccine efficacy against severe rotavirus
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 23 September 2009
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 23 September 2009 IXIARO suspension for injection Pack of 1 prefilled syringe + 1 needle (CIP: 393 958-0) Pack of
More informationFluzone High-Dose Vaccine and FIM12 Efficacy Trial Results
Fluzone High-Dose Vaccine and FIM12 Efficacy Trial Results Corey A. Robertson, MD, MPH Director, Scientific and Medical Affairs, Sanofi Pasteur 1 Older Adults Suffer Disproportionately from Influenza-related
More informationAn Open Randomized Study of Inactivated Hepatitis A Vaccine Administered Concomitantly with Typhoid Fever and Yellow Fever Vaccines
An Open Randomized Study of Inactivated Hepatitis A Vaccine Administered Concomitantly with Typhoid Fever and Yellow Fever Vaccines Elaine C. Jong, Karen M. Kaplan, Karen A. Eves, Colleen A.Taddeo, Hassan
More informationSAGE deliberations on CYD-TDV ( Dengvaxia )
SAGE deliberations on CYD-TDV ( Dengvaxia ) Annelies Wilder-Smith Consultant, Vaccines for Arboviral Diseases, WHO-IVB Scientific Coordinator ZIkaPLAN Director, Partnership for Dengue Control, Fondation
More informationDevelopment of dengue vaccines
Development of dengue vaccines Chee Siean Lim, Chit Laa Poh Centre for Virus and Vaccine Research, Sunway University, Selangor, Malaysia REVIEW Please cite this paper as: Lim CS, Poh CL. Development of
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Center: Indication: Treatment: Objective: 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.
More informationabstract n engl j med 373;13 nejm.org September 24,
The new england journal of medicine established in 1812 September 24, 2015 vol. 373 no. 13 Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease S.R. Hadinegoro, J.L. Arredondo
More information