Progress in new TB vaccine       development              Adam Stoten         Deputy General Manager Oxford-Emergent Tuber...
Global Plan to Stop TB: 2011 - 2015• STOP TB Targets       – By 2050, to reduce global incidence to less         than 1 pe...
Vaccination against TB• Bacille Calmette-Guerin (BCG) first introduced in 1921• 100 million doses per year, part of Expand...
Challenges for new TB vaccine                       development•   It is difficult to determine the efficacy of a new TB v...
Design of an improved TB vaccine• Retain BCG in new regime?• New vaccines needed to prevent:    – Infection in infants    ...
TB Vaccine Development:A Decade of Progress2000                   2002                     2009                      2012N...
Global TB Vaccine Pipeline                              Phase I                     Phase II             Phase IIb        ...
Global TB Vaccine Pipeline                              Phase I                     Phase II             Phase IIb        ...
OETC and MVA85A• The Oxford-Emergent Tuberculosis Consortium “OETC” was formed as a  joint venture between the University ...
MVA85A Trial Results• A single dose of MVA85A has been shown to be well tolerated and to induce  what we believe is the ri...
MVA85A Phase IIb efficacy trialsTarget Pop.          Infants                  HIV+ AdultsObjectives           • Safety    ...
Summary• Great progress has been made in the last 10 years• We cannot afford to lose momentum at this critical stage for t...
1000th infant vaccinated in Phase IIb trial of MVA85A at Worcester trial site, South Africa.   13
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Progress in new TB vaccine development

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The Power of Vaccines: ‘getting to zero’ for HIV and TB was an event hosted by the TB/HIV and Prevention Working Groups of the UK Consortium on AIDS and International Development. The meeting was sponsored by Pamela Nash MP and held on Friday, 18th May 2012, in Portcullis House, Westminster. Read more at http://storify.com/PamojaUK/the-power-of-vaccines

http://www.pamoja.uk.com

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Progress in new TB vaccine development

  1. 1. Progress in new TB vaccine development Adam Stoten Deputy General Manager Oxford-Emergent Tuberculosis Consortium “OETC” 1
  2. 2. Global Plan to Stop TB: 2011 - 2015• STOP TB Targets – By 2050, to reduce global incidence to less than 1 per million population – But will need 16% p.a. reduction to achieve this goal; current rate of reduction is ~1% p.a.*• How? – Use of current tools • DOTS – Introduction of new tools • New drugs • New diagnostics • New vaccines 2*Chris Dye, WHO, TB Vaccines, A Second Global Forum, 2010
  3. 3. Vaccination against TB• Bacille Calmette-Guerin (BCG) first introduced in 1921• 100 million doses per year, part of Expanded Programme for Immunisation (EPI) schedule• Variable efficacy – Effective against severe forms of the disease in infants when given at birth – Variable protection against pulmonary disease – Latitude effects; less effective near equator• WHO recommends that BCG is not given to HIV+ subjects due to risk of BCG-disseminated disease 3
  4. 4. Challenges for new TB vaccine development• It is difficult to determine the efficacy of a new TB vaccine candidate in the absence of a validated correlate of protection• Although prevalence of TB is high, low disease incidence rates dictate that efficacy trials must recruit large numbers of subjects with long periods of follow up• Large efficacy trials require significant trial site capacity in areas with high incidence• Clinical diagnosis of disease is difficult, especially in infants• Any successful vaccine will be required in huge quantities so a robust, scaleable manufacturing process is needed for global supply at affordable cost• Majority of doses will be needed in Developing World Countries and at low cost – reduces incentive for participation of commercial vaccine developers• Public funding support is vital for the progression of TB vaccine candidates through all stages of development 4
  5. 5. Design of an improved TB vaccine• Retain BCG in new regime?• New vaccines needed to prevent: – Infection in infants – Primary disease – Reactivation of latent TB – TB in HIV+ individuals• Potential for new therapeutic vaccines to be used in combination with current drugs to shorten treatment time• 3 basic strategies for preventative vaccines: – Boost BCG with new vaccine – Replace BCG with an improved BCG – Use new vaccine to boost an improved BCG 5
  6. 6. TB Vaccine Development:A Decade of Progress2000 2002 2009 2012No new preventive 2000 1st preventive 202 1st Phase IIb proof- 2009 15 vaccines have 2011TB vaccines in vaccine enters of-concept of entered clinicalclinical trials clinical preventive vaccine trials, 12 currently in trials (MVA85A) initiated clinical trials • 15 novel TB vaccine candidates have been in clinical trials in the last decade • Robust pipeline of 2nd generation candidates • New delivery platforms are being explored • Capacity and infrastructure development for large-scale trials occurring in several high burden countries • Epidemiological cohort studies conducted in several countries to provide baseline TB incidence data • Regulatory pathway elucidation and economic impact research being conducted now to lay the groundwork to accelerate adoption and uptake of new TB vaccines (J. Woolley, Aeras, 2012)
  7. 7. Global TB Vaccine Pipeline Phase I Phase II Phase IIb Phase III AdAg85A M72+AS01 MVA85A/ Mw [M. indicus pranii McMaster University GSK, Aeras AERAS-485 (MIP)] Oxford-Emergent Dept of Biotechnology Hybrid-I+CAF01 VPM 1002 Tuberculosis (India), M/s. Cadila SSI, TBVI Max Planck, Vakzine Consortium (OETC), Projekt Mgmt, TBVI Aeras H56+IC31 SSI, Aeras, Intercell Hybrid-1+IC31 AERAS-402/ Crucell SSI, TBVI, EDCTP, Ad35 Intercell Crucell, Aeras Hyvac 4/ AERAS-404 +IC31 SSI, sanofi-pasteur, Aeras, RUTI Intercell Archivel Farma, S.L. AERAS-422 Aeras Prime TB Vaccine Types Boost Viral-vectored: MVA85A, AERAS-402, AdAg85A Protein/adjuvant: M72, Hybrid-1, Hyvac 4, H56 Post-infection rBCG: VPM 1002, AERAS-422 Immunotherapy Killed WC or Extract: Mw, RUTISource: Tuberculosis Vaccine Candidates – 2011 (J. Woolley, Aeras, 2012)
  8. 8. Global TB Vaccine Pipeline Phase I Phase II Phase IIb Phase III AdAg85A M72+AS01 MVA85A/ Mw [M. indicus pranii McMaster University GSK, Aeras AERAS-485 (MIP)] Oxford-Emergent Dept of Biotechnology Hybrid-I+CAF01 VPM 1002 Tuberculosis (India), M/s. Cadila SSI, TBVI Max Planck, Vakzine Consortium (OETC), Projekt Mgmt, TBVI Aeras H56+IC31 SSI, Aeras, Intercell Hybrid-1+IC31 AERAS-402/ Crucell SSI, TBVI, EDCTP, Ad35 Intercell Crucell, Aeras Hyvac 4/ AERAS-404 +IC31 SSI, sanofi-pasteur, Aeras, RUTI Intercell Archivel Farma, S.L. AERAS-422 Aeras Prime TB Vaccine Types Boost Viral-vectored: MVA85A, AERAS-402, AdAg85A Protein/adjuvant: M72, Hybrid-1, Hyvac 4, H56 Post-infection rBCG: VPM 1002, AERAS-422 Immunotherapy Killed WC or Extract: Mw, RUTISource: Tuberculosis Vaccine Candidates – 2011 (J. Woolley, Aeras, 2012)
  9. 9. OETC and MVA85A• The Oxford-Emergent Tuberculosis Consortium “OETC” was formed as a joint venture between the University of Oxford and Emergent Product Development UK• OETC’s purpose is to develop and commercialise MVA85A for developed and developing world markets MVA85A Attenuated viral vector encoding 85A TB antigen Mode of action Boost to BCG Preclinical testing Improves BCG induced protection in mice, guinea pigs, non-human primates and cows Clinical testing in healthy Has undergone safety and immunogenicity subjects testing in healthy adults, adolescents, children and infants Clinical testing in high risk Has undergone safety and immunogenicity subjects testing in HIV–infected and latent TB-infected adults Status Two Phase IIb efficacy studies ongoing in infants and HIV-infected adults 9
  10. 10. MVA85A Trial Results• A single dose of MVA85A has been shown to be well tolerated and to induce what we believe is the right kind of immune response in: – Healthy adults, adolescents, children and infants – Adults with latent TB – Adults with HIV• Immune responses were lower in HIV infected adults than in healthy adults so a second dose has been introduced into trials in this population• MVA85A has been shown to have no adverse effects on existing EPI schedule vaccines when co-administered• Next important step is to determine whether these promising immune responses translate into protection from disease• MVA85A will be the first new TB vaccine candidate to generate efficacy data in infants, with results due at the end of 2012 10
  11. 11. MVA85A Phase IIb efficacy trialsTarget Pop. Infants HIV+ AdultsObjectives • Safety • Safety • Immunogenicity • Immunogenicity • Efficacy • EfficacyLocation South Africa South Africa and SenegalSubjects 2797 1400Doses Single dose Two dosesDesigned to show 60% improvement over 60% improvement BCG alonePartners Aeras, Wellcome Trust, EDCTP, Aeras, UCT, Le SATVI DantecStatus Recruitment complete Recruitment ongoing 11
  12. 12. Summary• Great progress has been made in the last 10 years• We cannot afford to lose momentum at this critical stage for the TB vaccine pipeline• New vaccine candidates such as MVA85A are on the brink of demonstrating efficacy• More funding is needed, particularly for conduct of Phase III trials and for capacity building• Importance of support for funding mechanisms such as EDCTP II to enable late stage vaccine trials 12
  13. 13. 1000th infant vaccinated in Phase IIb trial of MVA85A at Worcester trial site, South Africa. 13
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