The promise of new TB vaccines: The role of TBVAC2020 Stefan H.E. Kaufmann Max Planck Institute for Infection Biology, Berlin Chair TBVAC2020 Steering Committee TBVI Symposium Innovation in the TB vaccine field TBVAC2020 kick-off meeting 10 February 2015 IJmuiden, The Netherlands
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The promise of new TB vaccines: The role of …The promise of new TB vaccines: The role of TBVAC2020 Stefan H.E. Kaufmann Max Planck Institute for Infection Biology, Berlin Chair TBVAC2020
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The promise of new TB vaccines:
The role of TBVAC2020
Stefan H.E. Kaufmann
Max Planck Institute for Infection Biology, Berlin
Chair TBVAC2020 Steering Committee
TBVI Symposium
Innovation in the TB vaccine field
TBVAC2020 kick-off meeting
10 February 2015
IJmuiden, The Netherlands
Agenda
• The problem
• The future
• The promise of new TB vaccines
• Potential complications & solutions
• European perspective: TBVI and
TBVAC2020
• A broader picture: GTBVP
• Conclusions
Agenda
• The problem
• The future
• The promise of new TB vaccines
• Potential complications & solutions
• European perspective: TBVI and
TBVAC2020
• A broader picture: GTBVP
• Conclusions
TB: the biggest killer ever No. of deaths in the past 200 years (source: Nature)
Kaufmann, Immunity, 2010 Kaufmann, Immunity, 2010
…and this all costs money
…a lot of money
…more than generally
appreciated
Direct treatment costs of TB (excluding hospital and
additional costs) in Germany / NL:
Sensitive TB MDR-TB XDR-TB
7700 € 55,000 € 188,000 €
Costs of TB including hospitalization (30 days for
sensitive TB; 85 days for MDR-TB; > 4 months for XDR-
TB) and productivity much higher
based on Diel et al, ERJ, 2013
High TB burden countries
Sensitive TB MDR-TB XDR-TB
100 – 500 US$ 9,200 US$ 48,500 US$
(WHO 2014)
Recent cost analysis by TBVI:
The financial burden of TB in Europe
(estimated):
Germany: 50 million €
EU: 550 million €
European region of WHO: > 3 billion €
The 15 high-burden countries of the European region according
to WHO (only Bulgaria and Estonia EU members): 2.1 billion €
Calculated total loss (based on estimated monetary value of DALYs):
5.9 billion € (based on Diel et al, ERJ, 2013)
Agenda
• The problem
• The future
• The promise of new TB vaccines
• Potential complications & solutions
• European perspective: TBVI and
TBVAC2020
• A broader picture: GTBVP
• Conclusions
The Future of TB Control
Millennium development goal 6:
• Hold and reverse TB incidence by 2015
Achieved
Stop TB Partnership:
• Reduce by 50% TB mortality and prevalence
between 1990 and 2015
Unlikely to be reached, notably in Europe and
Africa
Post 2015 targets by Stop TB Partnership (WHO)
Initial proposal:
• Eliminate TB by 2050
(< 1/1 million new cases)
Realistic?
Revised (approved by World Health Assembly 2014):
• 95% reduction in TB deaths
• 90% reduction in TB disease incidences (between 2015
and 2035)
Ambitious.
The Future of TB Control
Projected acceleration of TB
incidence decline to target levels
Optimize current tools, pursue universal health coverage and social protection
Introduce new vaccine
Average -10%/year
-5%/year
Current global trend: -2%/year
Average -17%/year
Agenda
• The problem
• The future
• The promise of new TB vaccines
• Potential complications & solutions
• European perspective: TBVI and
TBVAC2020
• A broader picture: GTBVP
• Conclusions
BCG Today Protection:
• Against tuberculous meningitis and miliary TB in infants
Coverage:
• High (> 80%); part of the expanded program on
immunization (EPI) for infants
• Ca. 100 million children BCG-vaccinated per year
Ca. 4 billion vaccinations thus far
Safety:
• Very safe but adverse reactions possible
• Risk for HIV+ newborn
Cost:
• 0.1 – 0.5 US $ total (BCG, needle & syringe)
But : • No reliable protection against pulmonary tuberculosis &
transmission in all age groups
(variable efficacies)
Kaufmann, Lancet Infect Dis, , 2011
Global Clinical TB Vaccine Pipeline
Phase I Phase IIa Phase IIb PhaseIII
Ad5 Ag85A B McMaster University, Can Sino
Crucell Ad35 / Aeras402
B Crucell, Aeras
(formerly PhIIb)
MVA85A /Aeras-485 B UOXF, AERAS
M. Indicus pranii IT Dpt of Biotechn (Gvt of India),
Cadila
ID93 + GLA-SE B IDRI, Aeras
VPM1002 P MPIIB, VPM, TBVI, SII
M72 + ASO1E B GSK, Aeras
M. vaccae IT An Hui Longcom
MTBVAC P UniZaragoza, Biofabri, TBVI
RUTI IT Archivel Pharma
DAR-901 B Dartmouth University, Aeras
H I + IC31 B Valneva, TBVI, Intercell, EDCTP
ChAdOx1.85A B UOXF
H56 : IC31 B Valneva, Intercell, Aeras
Crucell Ad35 – MVA85A
prime-boost B UOXF, Aeras, Crucell
H4 : IC31 B Valneva, SP, Aeras
16 candidates
P priming vaccine
B boosting vaccine
IT therapeutic vaccines
Global Clinical TB Vaccine Pipeline
Phase I Phase IIa Phase IIb PhaseIII
Ad5 Ag85A B McMaster University, Can Sino
Crucell Ad35 / Aeras402
B Crucell, Aeras
(formerly PhIIb)
MVA85A /Aeras-485 B UOXF, AERAS
M. Indicus pranii IT Dpt of Biotechn (Gvt of India),
Cadila
ID93 + GLA-SE B IDRI, Aeras
VPM1002 P MPIIB, VPM, TBVI, SII
M72 + ASO1E B GSK, Aeras
M. vaccae IT An Hui Longcom
MTBVAC P UniZaragoza, Biofabri, TBVI
RUTI IT Archivel Pharma
DAR-901 B Dartmouth University, Aeras
H I + IC31 B Valneva, TBVI, Intercell, EDCTP
ChAdOx1.85A B UOXF
H56 : IC31 B Valneva, Intercell, Aeras
Crucell Ad35 – MVA85A
prime-boost B UOXF, Aeras, Crucell
H4 : IC31 B Valneva, SP, Aeras
16 candidates
P priming vaccine
B boosting vaccine
IT therapeutic vaccines
Half of them
current/former TBVI
involvement
Agenda
• The problem
• The future
• The promise of new TB vaccines
• Potential complications & solutions
• European perspective: TBVI and
TBVAC2020
• A broader picture: GTBVP
• Conclusions
…Money
…Time
…Innovation
…Strategy
The promise of new TB vaccines Financial constraints
Cost and time for TB vaccine trials:
• Phase I for safety and efficacy: 500,000 US$, >2 year
• Phase IIa in target population: 1 million US$, >2 years
• Phase IIb for first proof of efficacy: 20 million US$, >5 years
• Phase III for ultimate safety & efficacy: 100 million US$, >6 years
Global funding for TB vaccine R&D: 250 million US$
Conclusion: We need to be selective.
Kaufmann, Evans, Hanekom, Science Transl. Med., in press