TB Vaccine Research and Development: Progress, Strategies and Controversies
|
|
- Annis Morris
- 5 years ago
- Views:
Transcription
1 15 March 2016 GVIRF Global Forum Johannesburg, South Africa TB Vaccine Research and Development: Progress, Strategies and Controversies Lewis Schrager, M.D. V.P., Scientific Affairs Rockville, MD USA
2 Source: WHO Global TB Report
3 Outline Progress Major challenges in TB vaccine R&D efforts Controversies in the TB vaccine R&D field
4 The Global Clinical Pipeline of TB Vaccine Candidates Phase I Phase IIa Phase IIb Phase III Ad5 Ag85A RUTI M72 + AS01E Vaccae McMaster CanSino Archivel Farma, S.L GSK, Aeras Anhui Zhifei Longcom, China DAR-901 ID93 + GLA-SE VPM 1002 (rbcg) Dartmouth, Aeras IDRI, Aeras, Wellcome Trust Max Planck, VPM, TBVI, SII TB / FLU-04L RIBSP MTBVAC (Attenuated M.Tb) TBVI, Zaragoza, Biofabri Crucell Ad35 / MVA85A* Crucell, Oxford, Aeras H1: IC31 SSI, TBVI, EDCTP Viral Vector Protein / Adjuvant ChAdOx1.85A / MVA85A* Oxford, Birmingham H4: IC31 SSI, Sanofi-Pasteur, Aeras * Mycobacterial Whole Cell or Extract Experimental medicine tools / platforms MVA85A / MVA85A (ID, Aerosol)* H56 + IC31 Oxford SSI, Aeras Last updated 8/31/15
5 Candidate TB Vaccine Candidates: Summary of Status Description Status Comments Vaccae (M. vaccae) Heat killed WC Phase 3 PoD (China) Data due 2016 VPM-1002 Recombinant BCG -Phase 2b BCG replacement (S.A.) -Phase 3 PoR (India) M72:AS01E H4:IC31 H56:IC31 ID93:GLA-SE MTBVAC Live, attenuated Mtb DAR-901 Heat-killed M. obuense -Phase 2b PoD (S.A., Kenya, Zambia) -Phase 2 PoI (S.A.) -Phase 2 safety, immunogenicity (S.A.) -Phase 2a in treated TB patients ongoing (S.A.) Potential licensure submission(s) 2019 Data due 2018 Primary data due 2016; BCG comparator arm -Promising NHP data -PoI study in planning -Phase 2b PoR study planned -Primary pathway: BCG replacement (infants) -Follow-on to SRL-172 -Phase 2 PoD in planning PoD: Prevention of Disease; PoR: Prevention of Recurrent Disease; PoI: Prevention of Sustained Infection 5
6 Candidate TB Vaccine Candidates: Summary of Status Description Status Comments Vaccae (M. vaccae) Heat killed WC Phase 3 PoD (China) Data due 2016 VPM-1002 Recombinant BCG -Phase 2b BCG replacement (S.A.) -Phase 3 PoR (India) M72:AS01E H4:IC31 H56:IC31 ID93:GLA-SE MTBVAC Live, attenuated Mtb DAR-901 Heat-killed M. obuense -Phase 2b PoD (S.A., Kenya, Zambia) -Phase 2 PoI (S.A.) -Phase 2 safety, immunogenicity (S.A.) -Phase 2a in treated TB patients ongoing (S.A.) Potential licensure submission(s) 2019 Data due 2018 Primary data due 2016; BCG comparator arm -Promising NHP data -PoI study in planning -Phase 2b PoR study planned -Primary pathway: BCG replacement (infants) -Follow-on to SRL-172 -Phase 2 PoD in planning PoD: Prevention of Disease; PoR: Prevention of Recurrent Disease; PoI: Prevention of Sustained Infection 6
7 Candidate TB Vaccine Candidates: Summary of Status Description Status Comments Vaccae (M. vaccae) Heat killed WC Phase 3 PoD (China) Data due 2016 VPM-1002 Recombinant BCG -Phase 2b BCG replacement (S.A.) -Phase 3 PoR (India) M72:AS01E H4:IC31 H56:IC31 ID93:GLA-SE MTBVAC Live, attenuated Mtb DAR-901 Heat-killed M. obuense -Phase 2b PoD (S.A., Kenya, Zambia) -Phase 2 PoI (S.A.) -Phase 2 safety, immunogenicity (S.A.) -Phase 2a in treated TB patients ongoing (S.A.) Potential licensure submission(s) 2019 Data due 2018 Primary data due 2016; BCG comparator arm -Promising NHP data -PoI study in planning -Phase 2b PoR study planned -Primary pathway: BCG replacement (infants) -Follow-on to SRL-172 -Phase 2 PoD in planning PoD: Prevention of Disease; PoR: Prevention of Recurrent Disease; PoI: Prevention of Sustained Infection 7
8 Candidate TB Vaccine Candidates: Summary of Status Description Status Comments Vaccae (M. vaccae) Heat killed WC Phase 3 PoD (China) Data due 2016 VPM-1002 Recombinant BCG -Phase 2b BCG replacement (S.A.) -Phase 3 PoR (India) M72:AS01E H4:IC31 H56:IC31 ID93:GLA-SE MTBVAC Live, attenuated Mtb DAR-901 Heat-killed M. obuense -Phase 2b PoD (S.A., Kenya, Zambia) -Phase 2 PoI (S.A.) -Phase 2 safety, immunogenicity (S.A.) -Phase 2a in treated TB patients ongoing (S.A.) Potential licensure submission(s) 2019 Data due 2018 Primary data due 2016; BCG comparator arm -Promising NHP data -PoI study in planning -Phase 2b PoR study planned -Primary pathway: BCG replacement (infants) -Follow-on to SRL-172 -Phase 2 PoD in planning PoD: Prevention of Disease; PoR: Prevention of Recurrent Disease; PoI: Prevention of Sustained Infection 8
9 Candidate TB Vaccine Candidates: Summary of Status Description Status Comments Vaccae (M. vaccae) Heat killed WC Phase 3 PoD (China) Data due 2016 VPM-1002 Recombinant BCG -Phase 2b BCG replacement (S.A.) -Phase 3 PoR (India) M72:AS01E H4:IC31 H56:IC31 ID93:GLA-SE MTBVAC Live, attenuated Mtb DAR-901 Heat-killed M. obuense -Phase 2b PoD (S.A., Kenya, Zambia) -Phase 2 PoI (S.A.) -Phase 2 safety, immunogenicity (S.A.) -Phase 2a in treated TB patients ongoing (S.A.) Potential licensure submission(s) 2019 Data due 2018 Primary data due 2016; BCG comparator arm -Promising NHP data -PoI study in planning -Phase 2b PoR study planned -Primary pathway: BCG replacement (infants) -Follow-on to SRL-172 -Phase 2 PoD in planning PoD: Prevention of Disease; PoR: Prevention of Recurrent Disease; PoI: Prevention of Sustained Infection 9
10 Candidate TB Vaccine Candidates: Summary of Status Description Status Comments Vaccae (M. vaccae) Heat killed WC Phase 3 PoD (China) Data due 2016 VPM-1002 Recombinant BCG -Phase 2b BCG replacement (S.A.) -Phase 3 PoR (India) M72:AS01E H4:IC31 H56:IC31 ID93:GLA-SE MTBVAC Live, attenuated Mtb DAR-901 Heat-killed M. obuense -Phase 2b PoD (S.A., Kenya, Zambia) -Phase 2 PoI (S.A.) -Phase 2 safety, immunogenicity (S.A.) -Phase 2a in treated TB patients ongoing (S.A.) Potential licensure submission(s) 2019 Data due 2018 Primary data due 2016; BCG comparator arm -Promising NHP data -PoI study in planning -Phase 2b PoR study planned -Primary pathway: BCG replacement (infants) -Follow-on to SRL-172 -Phase 2 PoD in planning PoD: Prevention of Disease; PoR: Prevention of Recurrent Disease; PoI: Prevention of Sustained Infection 10
11 Candidate TB Vaccine Candidates: Summary of Status Description Status Comments Vaccae (M. vaccae) Heat killed WC Phase 3 PoD (China) Data due 2016 VPM-1002 Recombinant BCG -Phase 2b BCG replacement (S.A.) -Phase 3 PoR (India) M72:AS01E H4:IC31 H56:IC31 ID93:GLA-SE MTBVAC Live, attenuated Mtb DAR-901 Heat-killed M. obuense -Phase 2b PoD (S.A., Kenya, Zambia) -Phase 2 PoI (S.A.) -Phase 2 safety, immunogenicity (S.A.) -Phase 2a in treated TB patients ongoing (S.A.) Potential licensure submission(s) 2019 Data due 2018 Primary data due 2016; BCG comparator arm -Promising NHP data -PoI study in planning -Phase 2b PoR study planned -Primary pathway: BCG replacement (infants) -Follow-on to SRL-172 -Phase 2 PoD in planning PoD: Prevention of Disease; PoR: Prevention of Recurrent Disease; PoI: Prevention of Sustained Infection 11
12 Candidate TB Vaccine Candidates: Summary of Status Description Status Comments Vaccae (M. vaccae) Heat killed WC Phase 3 PoD (China) Data due 2016 VPM-1002 Recombinant BCG -Phase 2b BCG replacement (S.A.) -Phase 3 PoR (India) M72:AS01E H4:IC31 H56:IC31 ID93:GLA-SE MTBVAC Live, attenuated Mtb DAR-901 Heat-killed M. obuense -Phase 2b PoD (S.A., Kenya, Zambia) -Phase 2 PoI (S.A.) -Phase 2 safety, immunogenicity (S.A.) -Phase 2a in treated TB patients ongoing (S.A.) Potential licensure submission(s) 2019 Data due 2018 Primary data due 2016; BCG comparator arm -Promising NHP data -PoI study in planning -Phase 2b PoR study planned -Primary pathway: BCG replacement (infants) -Follow-on to SRL-172 -Phase 2 PoD in planning PoD: Prevention of Disease; PoR: Prevention of Recurrent Disease; PoI: Prevention of Sustained Infection 12
13 Candidate TB Vaccine Candidates: Summary of Status Description Status Comments Vaccae (M. vaccae) Heat killed WC Phase 3 PoD (China) Data due 2016 VPM-1002 Recombinant BCG -Phase 2b BCG replacement (S.A.) -Phase 3 PoR (India) M72:AS01E H4:IC31 H56:IC31 ID93:GLA-SE MTBVAC Live, attenuated Mtb DAR-901 Heat-killed M. obuense -Phase 2b PoD (S.A., Kenya, Zambia) -Phase 2 PoI (S.A.) -Phase 2 safety, immunogenicity (S.A.) -Phase 2a in treated TB patients ongoing (S.A.) Potential licensure submission(s) 2019 Data due 2018 Primary data due 2016; BCG comparator arm -Promising NHP data -PoI study in planning -Phase 2b PoR study planned -Primary pathway: BCG replacement (infants) -Follow-on to SRL-172 -Phase 2 PoD in planning PoD: Prevention of Disease; PoR: Prevention of Recurrent Disease; PoI: Prevention of Sustained Infection 13
14 High-Interest Pre-clinical Candidate: CMV-Vectored TB (Louis Picker, OHSU) Live, attenuated, persistent CMV vector Also used for HIV vaccine development (IAVI) Unique characteristics Stimulates tissue effector memory UL deletion stimulates MHC IIrestricted CD8+ T-cell responses Encouraging results in Rhesus macaque Mtb challenge studies Will need to address regulatory hurdles re: safety of live, persistent CMV 14
15 Non Human primates Donor Unrestricted T cells Aerosol and mucosal vaccination Whole Cell Vaccines B-cells and antibodies Conventional T-cells Funders Community
16 TB Vaccine R&D: Challenges Mono-focus on CD4+ T-cell responses; lack of immunological diversity Lack of immune correlate of protection Lack of a reliable, reproducible functional assay Lack of a human challenge model Human challenge consortium formed (Harvard, AECOM, Imperial College, Cornell, Rutgers, Aeras) Key issues Develop safe challenge strains (auxotrophs; genetic kill switches) Develop reporter methodology (blood-borne substrates; volatile aromatics) Achieve regulatory guidance/approval 16
17 TB Vaccine R&D: Challenges Poor predictive power and lack of standardized animal models that reliably predict human clinical outcomes Lack of funding* HIV vaccine funding, 2014: $841 million Malaria vaccine funding, 2014: ~$170 million Total TB vaccine funding, : ~$600 million *From Vaccines and Alternative Approaches: Reducing our Dependence on Antimicrobials. Review on Antimicrobial Resistance, Jim O Neill, Chair. February
18 TB Vaccine R&D: Controversies Resource allocation balance: experimental vs. vaccine product development Role of small animal models (mice, guinea pig, rabbit) in vaccine candidate evaluation Target patient population Infant-targeted vaccine (BCG replacement) Adolescent/adult targeted vaccine (prevention of infection and/or disease; reduce transmission) Choice of endpoint/indication Prevention of established Mtb infection (feasible/licensable?) Prevention of TB disease (IGRA- s vs. IGRA+ s) Prevention of recurrent disease (many variables; too high a bar?) Infant BCG vaccination effect of prior sensitization to vaccine development Effect of co-factors (e.g., DM, NTM exposure) on vaccine response 18
19 Acknowledgments Ann Ginsberg, Aeras Bernard Landry, Aeras Jessica Eisner, Aeras Zhongkai Shi, Aeras Nathalie Cadieux, Aeras Ravi Anantha, Aeras Thomas Scriba, UCT/SATVI 19
20 Recent Major Funders and R&D Partners And special thanks to the sites and participants in our clinical trials! 20
21 Thank You.
22 Potential Worldwide Impact of New TB Vaccines Immunization of infants, adolescents, adults with a 60% efficacious vaccine: 20% coverage rate for adolescents and adults 90% coverage rate for infants 22 Source: Aeras Not for circulation; estimates subject to change
Update on Tuberculosis Vaccines
March 27, 2014 Update on Tuberculosis Vaccines - 2014 Tom Evans MD CEO, Aeras TB is Mother Nature s AERAS GLOBAL number TB VACCINE one FOUNDATION killer over the past centuries TB is spread through the
More informationUrgent Need for Global Investment in TB Vaccines. Stop TB Partnership Board Meeting Jacqueline E. Shea, PhD Chief Executive Officer Aeras
Urgent Need for Global Investment in TB Vaccines Stop TB Partnership Board Meeting Jacqueline E. Shea, PhD Chief Executive Officer Aeras 2 We need a more effective vaccine than BCG 3 Global Strategies
More informationTB Vaccine Development Strategy Overview
TB Vaccine Development Strategy Overview October 28, 2014 Angeline Nanni, MBA, MS Aeras Director, Global Access TB is Mother Nature s number one killer over the past centuries TB is spread through the
More informationTB Vaccine Development Status: Review of Critical Issues and Selected Candidates in Phase 2 or Phase 3
TB Vaccine Development Status: Review of Critical Issues and Selected Candidates in Phase 2 or Phase 3 22 June 2017 WHO PD-VAC Geneva, Switzerland Lewis K. Schrager, M.D. North Bethesda, MD USA Outline
More informationDeveloping TB Vaccine Clinical Trial Capacity Aeras Perspective. Vicky Cardenas, PhD, JD
Developing TB Vaccine Clinical Trial Capacity Aeras Perspective Vicky Cardenas, PhD, JD ASEAN-EU STI Days 21-23 January 2014 Aeras Founded in 2003 Mission: Develop improved TB vaccines that are affordable
More informationAdvancing TB Vaccines for the World
Advancing TB Vaccines for the World Aeras Leadership EXECUTIVE STAFF Jacqui Shea, PhD Chief Executive Officer Ann Ginsberg, MD, PhD Chief Medical Officer BOARD MEMBERS Lota S. Zoth, CPA (Chair) Former
More informationTuberculosis The Race for a Cure
Tuberculosis The Race for a Cure Kari Stoever Faster Cures Annual Conference November 4, 2013 Aeras: A non profit biotech advancing TB vaccines for the world Founded in 2003 in-house capabilities in finance,
More informationNew Tools in the Post-UNHLM. David Lewinsohn StopTB Partnership New Tools Working Groups
New Tools in the Post-UNHLM David Lewinsohn StopTB Partnership New Tools Working Groups Ending TB Guiding Principles TB elimination not achievable without new tools While tools not widely available in
More informationTBVAC2020. Advancing novel & promising TB vaccine candidates from discovery to preclinical/early clinical development
TBVAC2020 Advancing novel & promising TB vaccine candidates from discovery to preclinical/early clinical development Défis Scientifiques et Economiques du Développement de Vaccins pour les Pays du Sud
More informationGlobal Report on Tuberculosis Vaccines 2018
Global Report on Tuberculosis Vaccines 2018 Executive Summary EDCTP Acknowledgements The Global Report on Tuberculosis Vaccines 2018 is prepared at the request of the Global TB Vaccine Partnership (GTBVP)
More informationTB vaccine progress. Hassan Mahomed. Institute of Infectious Disease and Molecular Medicine, School of Child and Adolescent Health,
TB vaccine progress Hassan Mahomed South African TB Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine, School of Child and Adolescent Health, University of Cape Town, South
More informationPerspective in novel TB vaccine development Mohamed Ridha BARBOUCHE M.D., Ph.D. Department of Immunology Institut Pasteur de Tunis
Perspective in novel TB vaccine development Mohamed Ridha BARBOUCHE M.D., Ph.D. Department of Immunology Institut Pasteur de Tunis Existing TB Vaccine is not effective for global TB epidemic control BCG
More informationUpdate on TB Vaccines
Update on TB Vaccines Hennie Geldenhuys 11 May 2012 A safe and effective TB Vaccine within a decade A Strategic Blueprint for the Next Decade Tuberculosis, Vol 92, March 2012, Suppl. 1, pgs S1-S35 On
More informationUpdate on TB Vaccines. Mark Hatherill South African TB Vaccine Initiative (SATVI) University of Cape Town
Update on TB Vaccines Mark Hatherill South African TB Vaccine Initiative (SATVI) University of Cape Town 1 Robert Koch s Therapeutic TB vaccine 1890: Purified Tuberculin Protein 1891: First negative reports
More informationPress Release: Embargo in place until Monday, February 19 th, 2018 I 6:00 Eastern standard Time (11GMT)
Press Release: Embargo in place until Monday, February 19 th, 2018 I 6:00 Eastern standard Time (11GMT) Results from innovative tuberculosis vaccine trial show potential for new BCG revaccination strategies
More informationNew Tuberculosis Vaccines Developmental Strategies
New Tuberculosis Vaccines Developmental Strategies Michael Brennan, Ph.D. Aeras SAGE Geneva, Switzerland 10 November 2011 The Potential of New TB Vaccines A new, more effective TB vaccine could: Be safer
More informationVaccine strategies to address drug-resistant tuberculosis. GJ Churchyard 20 th February 2018
Vaccine strategies to address drug-resistant tuberculosis GJ Churchyard 20 th February 2018 Overview MDR TB epidemiology AMR & MDR TB TB vaccines for MDR TB Pipeline Therapeutic vaccines Pre clinical Clinical
More informationThe Promises of the New TBVAC2020 Project
The Promises of the New TVAC2020 Project Stefan H.E. Kaufmann Max Planck Institute for Infection iology erlin World T Day Symposium in erlin: Tuberculosis control and prevention 17 18 March 2015 erlin
More informationGlobal progress in vaccine development
Global progress in vaccine development Helen McShane The Jenner Institute University of Oxford helen.mcshane@ndm.ox.ac.uk Vaccination The most cost-effective health intervention Smallpox Poliomyelitis
More informationDAR-901: inactivated Mycobacterium obuense
DAR-901: inactivated Mycobacterium obuense A whole cell non-tuberculous mycobacterial vaccine booster Fifth Global Forum on TB Vaccines New Delhi February 21, 2018 Ford von Reyn, MD Geisel School of Medicine
More informationClinical development of ID93 + GLA-SE as a prophylactic or therapeutic vaccine for tuberculosis
Clinical development of GLASE as a prophylactic or therapeutic vaccine for tuberculosis Tracey Day, PhD Senior Scientist Infectious Disease Research Institute 5 th Global Forum on TB Vaccines SG Reed 1,
More informationBetter Diagnostics for Tuberculosis: A Bolder Vision for TB Control. Peter M. Small, MD Senior Program Officer
Better Diagnostics for Tuberculosis: A Bolder Vision for TB Control Peter M. Small, MD Senior Program Officer peter.small@gatesfoundation.org June 21, 2010 Disclosure No financial/industry conflicts Patent
More informationVIR-2020: a CMV-based vaccine candidate for TB Aurelio Bonavia
VIR-2020: a CMV-based vaccine candidate for TB Aurelio Bonavia February 21, 2018, TB Global Forum, New Delhi, India INFECTIOUS DISEASES Massive Unmet Need 2,000,000,000 260,000,000 37,000,000 2,000,000
More informationPartnerships in TB Vaccine Research & Development. James E. Connolly President & CEO Aeras Global TB Vaccine Foundation
Partnerships in TB Vaccine Research & Development James E. Connolly President & CEO Aeras Global TB Vaccine Foundation Aeras Mission & GLOBAL the TB VACCINE PDP FOUNDATION Model Develop new, more effective
More informationThe Tuberculosis Vaccines Pipeline
The Tuberculosis Vaccines Pipeline TB Vaccines Back to basic science By Mike Frick The last year in tuberculosis (TB) vaccine research has demonstrated how setbacks can sometimes produce the potential
More informationPartnering to Support Research Capacity in TB Endemic Countries
Partnering to Support Research Capacity in TB Endemic Countries Dr. Tony Hawkridge Aeras Global TB Vaccine Foundation, Africa Office Fifth EDCTP Forum 13 October 2009 Arusha, Tanzania Invention of BCG
More informationMathematical modelling to accelerate development of new tuberculosis vaccines
Mathematical modelling to accelerate development of new tuberculosis vaccines Preliminary Results Rebecca Harris, Tom Sumner, Gwen Knight and Richard White 22 nd February 2018 Harris et al. 2016 Modelling
More informationRecent advances in the development of vaccines for tuberculosis
593891TAV0010.1177/2051013615593891Therapeutic Advances in VaccinesMJ Ahsan research-article2015 Therapeutic Advances in Vaccines Review Recent advances in the development of vaccines for tuberculosis
More informationCHAPTER 7.2 TUBERCULOSIS VACCINE CLINICAL TRIAL SITE DEVELOPMENT AND CLINICAL TRIALS. Hassan Mahomed, Willem Hanekom, Gregory D Hussey
Chapter7.2.indd 1094 CHAPTER 7.2 TUBERCULOSIS VACCINE CLINICAL TRIAL SITE DEVELOPMENT AND CLINICAL TRIALS Hassan Mahomed, Willem Hanekom, Gregory D Hussey The possibility of evaluating vaccine candidates
More informationThe non-human primate model in TB vaccine development
April 10, 2015 The non-human primate model in TB vaccine development Tom Evans MD Aeras Agenda Issues Transmission studies Recent advancements Outcomes Endpoint analysis Design Going forward 2 Development
More informationThe potential public health impact of new TB vaccines
The potential public health impact of new TB vaccines 5 th Global Forum on TB Vaccines Richard White 1,2, Rebecca Harris 2, Chathika Weerasuriya 2 1 TB Modelling and Analysis Consortium 2 TB Modelling
More informationTBVI the European Tuberculosis Vaccine Ininiative. Brigitte GICQUEL INSTITUT PASTEUR
TBVI the European Tuberculosis Vaccine Ininiative Brigitte GICQUEL INSTITUT PASTEUR Moving towards a TB free world in 2050 Foundation to facilitate European efforts Foundation to facilitate European efforts
More informationProspective Models of Vaccine Security Collaborations in Research and Development
Prospective Models of Vaccine Security Collaborations in Research and Development Georges Thiry, PhD IVI (International Vaccine Institute) Phuket, Oct 01, 2014 Content R&D Examples of collaborations from
More informationLetter from the CEO. Dear Friends of IAVI,
IAVI Annual Report 2017 Letter from the CEO Dear Friends of IAVI, We are pleased to present an overview of the progress IAVI and partners have made in 2017 toward our pursuit of the development of vaccines
More informationSummary of Key Points WHO Position Paper on BCG Vaccine, February 2018
Summary of Key Points WHO Position Paper on BCG Vaccine, February 2018 1 Introduction This position paper replaces the 2004 WHO position paper on Bacille Calmette-Guérin (BCG) vaccine and the 2007 WHO
More informationThe global tuberculosis (TB) epidemic. The Challenges Of Developing New Tuberculosis Vaccines. Fighting Critical Diseases
By Lewellys F. Barker, Annmarie E. Leadman, and Bartholt Clagett The Challenges Of Developing New Tuberculosis Vaccines doi: 10.1377/hlthaff.2011.0303 HEALTH AFFAIRS 30, NO. 6 (2011): 1073 1079 2011 Project
More information#4 (Tuberculosis OR TB OR Pulmonary Tuberculosis OR Multi-Drug Resistant Tuberculosis OR MDR OR Extremely-Drug Resistant Tuberculosis or XDR)
DATABASE Cochrane Database of Systematic Reviews DATE 15 DECEMBER 2015 #1 Safety of Crucell Ad35/ AERAS-402 OR Effectiveness of Crucell Ad35/ Aeras-402 OR Safety of MVA85A/ Aeras-485 OR Effectiveness of
More informationChildhood TB (and the mother-child dyad)
Childhood TB (and the mother-child dyad) Chairs: Mark Cotton and Lisa Nelson Rapporteur: Soumya Swaminathan Speakers Anneke Hesseling Philippa Musoke Amita Gupta Jerald Sadoff Over 2 million paediatric
More informationFifth Global Forum on TB Vaccines
Media coverage Fifth Global Forum on TB Vaccines The Hindi http://www.thehindu.com/sci-tech/health/experts-urge-more-funds-to-tackle-tuberculosiscrisis/article22809370.ece HEALTH Experts urge more funds
More informationTUBERCULOSIS VACCINE CANDIDATES 2010 Stop TB Partnership Working Group on New TB Vaccines
TUBERCULOSISVACCINECANDIDATES 2010 StopTBPartnershipWorkingGrouponNewTBVaccines According to the Global Plan to Stop TB, 2006-2015, Encouraging and consistent scientific results from the laboratory and
More informationProduct Development for Vaccines Advisory Committee:
Product Development for Vaccines Advisory Committee: Highlights from the 2016 year of vaccine development SAGE, October 2016 David C. Kaslow, MD Chair, Product Development for Vaccines Advisory Committee
More informationTherapeutic TB vaccines Shortening Treatment for (DS- and) DR-TB?
Therapeutic TB vaccines Shortening Treatment for (DS- and) DR-TB? Mark Hatherill South African Tuberculosis Vaccine Initiative (SATVI) University of Cape Town, South Africa 1 1. The need for a therapeutic
More informationMonitoring tuberculosis progression using MRI and stereology
Monitoring tuberculosis progression using MRI and stereology TB the problem Estimated number of new cases in 2007 2 million deaths; 9 million new cases p.a. TB kills someone every 15 secs, 9,153 cases
More informationTreatment Action Group Online Toolkit
1 1 Treatment Action Group Online Toolkit INTRODUCTION The aim of the TB/HIV Activist Toolkit is to provide activists with fundamental information about tuberculosis (TB) and TB/HIV coinfection in order
More informationWHO Preferred Product Characteristics for New Tuberculosis Vaccines DEPARTMENT OF IMMUNIZATION, VACCINES AND BIOLOGICALS WHO/IVB/18.
WHO/IVB/18.06 WHO Preferred Product Characteristics for New Tuberculosis Vaccines DEPARTMENT OF IMMUNIZATION, VACCINES AND BIOLOGICALS Family, Womens s and Children s Health (FWC) This document was produced
More information10. RESEARCH AND DEVELOPMENT
page 170 Monitoring results: goals, strategic objectives and indicators 10. RESEARCH AND DEVELOPMENT Progress towards development of tb vaccines (Indicator SO6.1) Background In March 1993, WHO designated
More informationFUNDERS UPDATE- BMGF. Third HIV Env Manufacturing Workshop Sponsored by DAIDS-NIAID-NIH and the HIV Global Vaccine Enterprise July 20-21, 2017
FUNDERS UPDATE- BMGF Third HIV Env Manufacturing Workshop Sponsored by DAIDS-NIAID-NIH and the HIV Global Vaccine Enterprise July 20-21, 2017 Susan Barnett Senior Program Officer, Product and Clinical
More informationNew Vaccines in SA. Regulatory Perspectives James Southern 2015
New Vaccines in SA Regulatory Perspectives James Southern 2015 Outline Regulatory Environment of new vaccines Clinical Trials Application procedures HIV Vaccines Other new vaccines in development Ongoing
More informationWHO Preferred Product Characteristics for New Tuberculosis Vaccines. World Health Organization 2017
1 2 3 4 5 6 7 8 WHO Product Characteristics for New Tuberculosis Vaccines 9 10 11 12 13 14 15 16 17 18 19 20 21 World Health Organization 2017 1 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40
More informationTuesday. Welcome Remarks Fabio. TB disease burden Lixia. Main. Tuberculosis (China) MDR-TB in China. Glenda Gray, South. Cape. (China) (USA/China)
Tuesday 21 April 2015 888:30 10:15 OPENING SESSION Plenary Hall Co-Chairs: Tom Evans, Aeras (USA) Nick Drager, TBVI (The Netherlands) Heping Xiao, Shanghai Pulmonary Hospital, Tongji University Medical
More informationTB-VAC. An integrated project for the design and testing of vaccine candidates against tuberculosis: identification, development, and clinical studies
TB-VAC An integrated project for the design and testing of vaccine candidates against tuberculosis: identification, development, and clinical studies Tuberculosis-a worldwide problem 30 % of the world
More informationConfronting infectious diseases and the role of vaccination: A global perspective KATE ANTEYI. MD, MPH, MBA
Confronting infectious diseases and the role of vaccination: A global perspective KATE ANTEYI. MD, MPH, MBA Technical Advisor, United States Agency for International Development (USAID) Chair, WONCA Working
More informationEC research and innovation strategy and actions
EC research and innovation strategy and actions for preparedness and response to outbreaks IMI Stakeholder Forum 28-29 September 2016 Line Matthiessen Head of Unit E.3 Health Directorate DG Research &
More informationCorrespondence: Aldar Bourinbaiar * Tel: ; *
Results from Phase III, placebo-controlled, 2:1 randomized, double-blind trial of tableted TB vaccine (V7) containing 10 μg of heat-killed Mycobacterium vaccae administered daily for one month Correspondence:
More informationMalaria Vaccine Pipeline
Malaria Vaccine Pipeline Perspectives and Challenges Carla Botting World Vaccine Congress Asia 2008 3 June 2008 Discussion Points Scope of the problem: the burden and challenge of malaria Malaria vaccine
More informationHVTN P5 Vaccine Trials
HVTN P5 Vaccine Trials Erica Andersen-Nissen, PhD Director, Cape Town HVTN Immunology Laboratory Considerations for a Pan-African HIV Vaccine Development Agenda Kigali, Rwanda 16-17 March 2015 HVTN Mission
More informationThe Crisis in. Vaccine Development
The Crisis in Vaccine Development Stanley A. Plotkin 1 Annecy 2015 The Evolution of the Vaccine Industry 1. 18 th -19 th Centuries Pioneers 2. 1900-1950 National Producers 3. 1960-1980 Globalization 4.
More informationGlobal health and vaccination: TB & beyond. Dr Mary Moran Executive Director
Global health and vaccination: TB & beyond Dr Mary Moran Executive Director mmoran@policycures.org Outline About Policy Cures 3 reasons to focus on vaccine innovation Where are we today? The pipeline Where
More informationTBVI Symposium TB Vaccines and Immunity MTBVAC, an update
TBVI Symposium TB Vaccines and Immunity MTBVAC, an update Eugenia Puentes, Biofabri Annual TBVAC 2020 Meeting, 1 st 5 th February 2016, Les Diablerets CONSTRUCTION OF MTBVAC Derived from a clinical isolate
More informationThe Value of Product Development Partnerships in Vaccine Innovation. Hansi J. Dean International AIDS Vaccine Initiative
The Value of Product Development Partnerships in Vaccine Innovation Hansi J. Dean International AIDS Vaccine Initiative The Product Development Partnership Model A non-profit partnership of public and
More informationProgramme Annual TBVAC2020 Meeting 1-5 February (including TBVI symposium)
Programme Annual TBVAC2020 Meeting 1-5 February (including TBVI symposium) Hotel Eurotel Victoria Les Diablerets Switzerland Monday 1 and Tuesday 2 February 2016 Separate internal TBVAC2020 WP meetings
More informationUniversity of Cape Town
CORRELATES OF RISK OF TB DISEASE IN INFANTS WITH DIFFERENTIAL RESPONSE TO BCG VACCINATION By Samuel Ayaba Njikan A dissertation submitted in fulfillment of the requirements for the degree of Doctor of
More informationStart Date* Sites Description
076 17 083 180 084 100 085 90 098 94 Inovio rad35 clade A clade A rad clade B clade B PENNVAX-GP IL-12 adjuvant September-11 Seattle The study looks at the immune response of genital and rectal tissues
More informationJournal of Asian Scientific Research
Journal of Asian Scientific Research ISSN(e): 2223-1331/ISSN(p): 2226-5724 URL: www.aessweb.com AN UPDATE ON NEW VACCINES FOR TUBERCULOSIS Afshan Sumera 1 --- Leong Chia Inn 2 --- Ankur Barua 3 1 Lecturer,
More informationThe global tuberculosis epidemic and progress in care, prevention, and research: an overview in year 3 of the End TB era
THELANCETRM-D-7-00703R2 S223-2600(8)07-2 With issue Doctopic: Review and Opinion WHO copyright 7TLRM0703 Review GM This version saved: 09:06, 3-Mar-8 The global tuberculosis epidemic and progress in care,
More informationSupplementary Figure 1
Supplementary Figure 1 FMO control (no HLA-DR antibody) FMO control (no HLA-DR antibody) Supplementary Figure 1. Gating strategy for HLA-DR+ T-cells. A gate was drawn around lymphocytes based on cell size
More informationSAMRC S RESPONSE TO HIV & TB: WALKING THE TALK: MOVING TO CONTROL
SAMRC S RESPONSE TO HIV & TB: WALKING THE TALK: MOVING TO CONTROL Glenda Gray President & CEO SAMRC 1 SA AIDS 2017 Durban 15 June 2017 Partner logo LEADERSHIP IN A TIME OF UNCERTAINTY 2 BASELINE BUDGET
More informationNew Vaccines for Global Health. Adrian Hill The Jenner Institute, Oxford University
New Vaccines for Global Health Adrian Hill The Jenner Institute, Oxford University 1796: Jenner Invents Vaccination Edward Jenner DM (Oxon) Synergies in Human and Livestock Vaccine Development Same or
More informationSeasonal 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
More informationUpdate: Working Group on New Vaccines. David Lewinsohn Chair, Working Group on New Vaccines
Update: Working Group on New Vaccines David Lewinsohn Chair, Working Group on New Vaccines The Stop TB Partnership Global Partners' Forum Global TB Drug Facility GLC Coordinating Board Partnership Secretariat
More informationRecent advances in management of tuberculosis in infants
European Review for Medical and Pharmacological Sciences 2017; 21: 2467-2472 Recent advances in management of tuberculosis in infants Q. ZHEN, C.-L. ZHANG, L. GONG Department of Respiration, Xuzhou Children
More informationEVIDENCE SYNTHESIS FOR GLOBAL HEALTH: ANIMAL STUDIES UNDER THE LENS
EVIDENCE SYNTHESIS FOR GLOBAL HEALTH: ANIMAL STUDIES UNDER THE LENS Paul Garner On behalf of the Cochrane infectious Diseases Group Editors And the Effective Health Care Research Programme Consortium Competing
More informationTB, BCG and other things. Chris Conlon Infectious Diseases Oxford
TB, BCG and other things Chris Conlon Infectious Diseases Oxford Epidemiology Latent TB IGRA BCG >50/100000
More informationHVTN Laboratory Program: Immunogenicity and Research Assays
HVTN Laboratory Program: Immunogenicity and Research Assays Erica Andersen-Nissen, PhD Director, Cape Town HVTN Immunology Laboratory Considerations for a Pan-African HIV Vaccine Development Agenda Kigali,
More informationTABLE 7 ADVANTAGES AND DISADVANTAGES OF TOXOID VACCINES SUBUNIT VACCINES Applications of Subunit Vaccines TABLE 8 APPLICATIONS OF
CHAPTER ONE: INTRODUCTION... 1 STUDY OBJECTIVES... 1 REASONS FOR DOING THIS STUDY... 1 INTENDED AUDIENCE... 2 SCOPE OF THE STUDY... 2 METHODOLOGY... 2 INFORMATION SOURCES... 2 ABOUT THE AUTHOR... 3 RELATED
More informationRoadmaps as a Vehicle for Addressing Large- Scale Public Health Challenges: Lessons from the Malaria Vaccine Technology Roadmap
Background to development of vaccine roadmaps, to include priority areas for research, product development, capacities, and policy and commercialization Roadmaps as a Vehicle for Addressing Large- Scale
More informationPrevalence of tuberculosis (TB) infection and disease among adolescents western Kenya: preparation for future TB vaccine trials
Prevalence of tuberculosis (TB) infection and disease among adolescents western Kenya: preparation for future TB vaccine trials Videlis Nduba 1,2, Peter Onyango 1, Anja Van t Hoog 1,3, Anthony Hawkridge
More informationCrucell a compelling investment case
Crucell a compelling investment case Investor Presentation March 2008 Disclaimer The presentation contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain
More informationTheresa NeSmith Centers for Disease Control and Prevention Center for Global Health Division of Global HIV/AIDS International Laboratory Branch
Theresa NeSmith Centers for Disease Control and Prevention Center for Global Health Division of Global HIV/AIDS International Laboratory Branch PEPFAR Laboratory Program is a Critical Part of Health Systems
More informationHIV vaccine research and development
HIV vaccine research and development What is an HIV vaccine and how does it work? An HIV vaccine is a substance given to the body to teach it to defend itself against HIV. A successful preventative HIV
More informationBCG: Past, Present and Future. Nwora Lance Okeke, MD, MPH August 24, 2016
BCG: Past, Present and Future Nwora Lance Okeke, MD, MPH August 24, 2016 Disclosures Nothing to disclose Overview Introduction and History Current Use Effectiveness Non-vaccine uses of BCG Edmond Nocard
More informationHow and Why Vaccines Are Developed by Industry. Stanley A. Plotkin
How and Why Vaccines Are Developed by Industry Stanley A. Plotkin Merieux 2012 1 Why Vaccines are Different than Drugs 1) Given to healthy people, high safety required 2) Larger governmental role 3) Low
More informationDriving access to medicine
Driving access to medicine An example from the Novartis Malaria Initiative Hans Rietveld Director, Market Access & Capacity Building Novartis Malaria Initiative Social Forum - Geneva February 20, 2015
More informationMalaria. Dr. Salim Abdulla, Director Ifakara Health Institute, Dar-es-salaam, Tanzania
Malaria Dr. Salim Abdulla, Director Ifakara Health Institute, Dar-es-salaam, Tanzania Despite 42% reduction since 2000, a child dies every minute in Africa from malaria 207 million malaria cases in 2012,
More informationDevelopment of VPM1002/rBCG urec::hly Tuberculosis vaccine
eine Initiative des Bundesministeriums für Bildung und Forschung (BMBF) Development of VPM1002/rBCG urec::hly Tuberculosis vaccine Bernd Eisele M.D. CEO Vakzine Projekt Management GmbH eisele(at)vakzine-manager.de
More informationHIV Vaccine Clinical Trials at CIDRZ
HIV Vaccine Clinical Trials at CIDRZ Developing a Safe and Effective Vaccine for Prevention of HIV Infections Globally Christine Namakobo Senior Research Nurse Matero Clinical Research Site State of Global
More informationUpdate on Pentavalent Human-Bovine Rotavirus Vaccine. Michelle Goveia, MD, MPH Medical Director MSD Vaccines India, September 2014
Update on Pentavalent Human-Bovine Rotavirus Vaccine Michelle Goveia, MD, MPH Medical Director MSD Vaccines India, September 2014 Outline Characteristics of RotaTeq and its worldwide use Recent data evaluating
More informationA NEW PARADIGM FOR TRANSLATIONAL VACCINE DEVELOPMENT. Introducing the Gates Medical Research Institute
A NEW PARADIGM FOR TRANSLATIONAL VACCINE DEVELOPMENT Introducing the Gates Medical Research Institute MY JOURNEY A NEW PARADIGM FOR TRANSLATIONAL VACCINE DEVELOPMENT Introducing the Gates Medical Research
More informationVPM1002 A new TB prime vaccine on the horizon Leander Grode Caroline Sauer Umesh Shaligram CSO/Director BD Project Manager Director R&D
VPM1002 A new TB prime vaccine on the horizon Leander Grode Caroline Sauer Umesh Shaligram CSO/Director BD Project Manager Director R&D Vakzine Projekt Management GmbH Serum Institute of India Ltd Who
More informationTransforming The Approach to Vaccines and Protein- Based Therapeutics. Alain Doucet, Ph.D. Manager, Process Development, Medicago
Transforming The Approach to Vaccines and Protein- Based Therapeutics Alain Doucet, Ph.D. Manager, Process Development, Medicago 2018-08-15 1 Medicago Overview 2 Novel Technologies 3 Robust Pipeline 2
More informationThe Value of Vaccines in the Avoidance of Antimicrobial Resistance
The Value of Vaccines in the Avoidance of Antimicrobial Resistance Report on Workshop of 29-30 March 2017 Charles Clift Centre on Global Health Security, Chatham House The Royal Institute of International
More informationA Quarterly Update on HIV Prevention Research. Vol. 8 No. 2
What is it? What could it do? Key Facts Antibodies Passive immunization is the transfer of pre-made antibodies to a person. Passive immunization using today's pre-made antibodies can involve infusion delivered
More informationVPM1002 A new TB prime vaccine on the horizon Leander Grode Project Manager/ Director BD
VPM1002 A new TB prime vaccine on the horizon Leander Grode Project Manager/ Director BD Vakzine Projekt Management GmbH Mellendorfer Str. 9 D-30625 Hannover Telephone: +49 511 169908 0 grode(at)vakzine-manager.de
More informationShould There be Further Efficacy Testing of T-T cell Based Vaccines that do not Induce Broadly Neutralizing Antibodies?
Dale and Betty Bumpers Vaccine Research Center National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services Should There be Further Efficacy
More informationImmunology of TB and its relevance to TB Control
Immunology of TB and its relevance to TB Control W. Henry Boom, M.D. TB Research Unit Case Western Reserve University NIAID-DMID: -AI70022 Global TB Epidemiology 2009 < 10 10 to 24 25 to 49 50 to 99 100
More informationVaccine Technologies and Global Markets
A BCC Research Pharmaceutical Report and Global Markets PHM014D Use this report to: Learn about the strengths and weaknesses of each category of human and veterinary vaccine to prevent or treat infectious
More informationDeveloping a novel Group B Streptococcus (GBS) Vaccine. Patrick Tippoo
Developing a novel Group B Streptococcus (GBS) Vaccine Patrick Tippoo Presentation 1. Overview of Biovac 2. GBS Project Overview 3. African Significance Biovac Overview A Centre of Excellence rooted in
More informationPolio vaccines and polio immunization in the pre-eradication era: WHO position paper. Published in WER 4 June, 2010
Polio vaccines and polio immunization in the pre-eradication era: WHO position paper Published in WER 4 June, 2010 Epidemiology & Background Poliomyelitis (polio) is an acute communicable disease of humans
More informationExpanding Latent Tuberculosis Infection Testing and Treatment to Accelerate Tuberculosis Elimination
IUATLD North American Region Conference February 24, 2017 Vancouver, BC Expanding Latent Tuberculosis Infection Testing and Treatment to Accelerate Tuberculosis Elimination Philip LoBue, MD National Center
More informationGlobal Advisory Committee on Vaccine Safety (GACVS) Report from the June 2017 meeting
Global Advisory Committee on Vaccine Safety (GACVS) Report from the June 2017 meeting Topics discussed in June Safety monitoring of the RTS,S vaccine pilot implementation programme Safety update of BCG
More information