Global Plan to Stop TB 200615 Working Group on New Vaccines

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Global Plan to Stop TB 2006-15Working Group on
New Vaccines

• Addis Ababa 2nd May 2005

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• Global Plan 2000-05
• Global Plan 2006-15
• cost estimates
• impact
• Working Group methods

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Global Plan 2000-05
OBJECTIVES
Five candidates in Phase I trials by 2005
M72f protein in adjuvant Reed,
Corixa/GSK USA/Europe MVA-85A Mtb gene in
vaccinia Hill, Oxford UK/Gambia rBCG30 recombina
nt BCG Horwitz, UCLA USA
Ag85B/ESAT-6 protein in adjuvant Andersen,
SSI mid-2005 rBCGDUreCHly recombinant
BCG Kaufmann, Berlin Q3 2005
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The BCG Question

• protects against severe forms of childhood TB
• (and long-lived protection in some
  populations)

• promising results with prime-boost protocols
• in animal models

new vaccine will add something to BCG
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Global Plan 2006-15
OBJECTIVES
Safe, effective, licensed vaccine available
at reasonable cost by 2015

• sufficient production capacity available by
  2015
• widely distributed by 2020

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Vaccine Development Timeline
2015
2015
2011
2012
2013
2014
2005
2006
2007
2008
2009
2010
does it induce the right immune response?
is it safe? HIV, latent TB, children . . .
does it protect against TB?
License, Launch Distribute
Phase I and Phase II trials
Phase III trial
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Pre-Exposure and Post-Exposure Vaccination
pre-exposure
primary TB
primary TB

post-exposure
therapeutic?
cure
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Parallel track strategy

• Parallel track development - pre- and
  postexposure idea is to come to a fusion of both
  tracks around 2015

Clinical development 2005 2008
2013
2015
Pre-exposure Post-exposure

• Premature to settle on one implementation
  scenario (modeling)
• Ideal only one new vaccine for pre-
  and post-exposure
• e.g. BCG fusion protein boost (under
  EPI schedule) resulting in (life?) long-lasting
  protection
• e.g. same new vaccine usable for
  boosts in neonates in late childhood/early
  adolescents (adults?)
• Acceptable but not ideal pre and
  post-exposure vaccine different
• e.g. recombinant BCG for neonates
  plus subunit vaccine as booster for adolescents

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Vaccine Development Timelines
2015
2015
2011
2012
2013
2014
2005
2006
2007
2008
2009
2010
Site Preparation Epidemiology
Factory Construction Validation, Consistency
End Point Immune Assay Validation
Phase I,II, IIB Protein I Adj 1
Phase III Infants BCGprime/Protein
boost Adolescents - Protein
Ph I,II Protein Ia Adj 2
Preclinical
License, Launch Distribute
Preclinical
Ph I,II Protein 2 Adj 3
Preclinical
Ph I,II rBCG, rTB
Phase III Infants rBCG or rTB prime Viral
Vector Boost Adolescents - Vector
Ph I, II BCG/ viral vector I
Process Develop. Viral l
Ph I, II Viral 2
Preclinical
Preclinical
Ph I, II Protein 34
Phase III Post Infection /- rBCG prime Viral
Vector Boost
License
Preclinic
Ph I,II Viral 3
Preclinic
Ph I,II rBCG 2
Preclinic
Ph I,II Viral 4
Preclinic
Ph I,II Viral 5
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Costs for Vaccine Development
2015
2015
2011
2012
2013
2014
2005
2006
2007
2008
2009
2010
4 trials 40,000 subjects 240
production facility 100
License, Launch Distribute
Phase I and Phase II trials
Phase III trial
million US
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Vaccine Budget for Global Plan
Cost
Gap BCG 1300
0 Research translation
1200 490 Preclinical development
15 15 Site Capacity 15
3 Production/scale-up
192 187 Clinical trials
387
341 Preparation of access 1
0 WG Facilitation
6 5 Total
3116 1041
million US
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Vaccine Impact Post-2015
Vaccine introduction
Pre-exposure
Incidence
Post-exposure (e.g. adolescent vaccination
programme)
Post-exposure in a mass-vaccination paradigm
(everybody!)
Time
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Stakeholders

• Government RD Sponsors (NIH, MRC, EU)
• National Public Health Institutions (CDC)
• Scientists
• Regulatory Agencies
• Philanthropy (BM Gates AERAS, Wellcome Trust)
• Pharmaceutical Industry
• Other Stop TB WGs

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Global Plan Drafting Group
Michael Iademarco CDC Michael Brennan
FDA Jerry Sadoff Aeras Christine
Sizemore NIH Natalie Waugh Aeras Peter Small
BMGF Uli Fruth WHO
Montreux March 2005 Whistler April 2005 (cost
estimates) Bethesda April 2005 email
. . . .
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Role of the Working Group
preclinical clinical trials manufacture
Gates, EU, NIH Wellcome Trust
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Working Group Activities

• Prepare Scientific Blueprint
• Elaborate Economic Analysis
• Facilitate International Regulatory
  Harmonization
• Provide Preclinical Clinical Standards
• Ensure timely vaccine production/availability
• Prepare accelerated access in countries

6 million
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• elect new chair
• review terms of reference
• review membership
• professional management

• targets and timelines
• advance planning for meetings
• financial planning and reporting