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Aeras Global TB Vaccine Foundation

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Berlin, Germany
12 November 2010
 AERAS GLOBAL TB VACCINE FOUNDATION
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 BCG unreliable against pulmonary TB, which
accounts for most TB disease worldwide

 BCG is not know to protect against latent TB

 BCG is not recommended for use in infants

infected with HIV - increased risk for severe
BCG-related complications

 espite wide use, BCG has had no apparent

impact on the growing global TB epidemic

 BCG does reduce risk of severe pediatric TB

disease, so it should continue to be used
until a better TB vaccine is available
 AERAS GLOBAL TB VACCINE FOUNDATION

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 ‰ The vaccine against tuberculosis that
is routinely given to 75 percent of the world¶s
infants is too risky to give to those born infected
with the AI
virus, says a new study published
by the World Health Organization. It
recommended that vaccination be delayed until
babies can be tested.
 AERAS GLOBAL TB VACCINE FOUNDATION

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 Children with HIV infection

regardless of symptoms should not
be BCG vaccinated

 All high risk infants need HIV

screening
‰ aternal antibody masks antibody
tests
‰ etection of virus required
‰ Very difficult to implement in many
places

 isseminated BCG in HIV infected infants recently (2009) estimated

to be 992 per 100,000 (Hesseling, et al)


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AERAS GLOBAL TB VACCINE FOUNDATION

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 AERAS GLOBAL TB VACCINE FOUNDATION
    
 liminate TB as a public health
threat, in line with global targets
(<1 case/million), in conjunction
with new drugs and diagnostics

afe and effective in preventing
TB in children, adolescents and
adults, including people with
HIV (for whom BCG is unsafe)
 rotect against all forms of TB ‰
including  and X 
 AERAS GLOBAL TB VACCINE FOUNDATION

    

 uropean efforts to develop

more effective, safe vaccines
against tuberculosis, that will
be globally accessible and
affordable.

  support and Advocacy

 Focus:
‰ iscovery
‰ reclinical
‰ hase I/IIa - early clinical stages
 AERAS GLOBAL TB VACCINE FOUNDATION
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To develop new, more effective TB
vaccines and ensure their availability to
all who need them

 
 Non-profit   collaborate with
academic, biotech, pharma and NGO
partners to develop and test new TB
vaccines
 ursue a rime-Boost strategy by
developing a modern replacement for
BCG plus booster vaccines
 evelop vaccines in our own lab and
manufacturing plant
  


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vaccine candidates are not yet in clinical trials, but have been manufactured under Good anufacturing ractice
(G ) for clinical use and have undergone some preclinical testing that meets regulatory standards.
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ource: Tuberculosis Vaccine Candidates ‰ 2009
top TB artnership Working Group on New TB Vaccines
 AERAS GLOBAL TB VACCINE FOUNDATION

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 12 candidates have entered clinical trials 9 currently
being tested 10th will enter trials this year
 obust pipeline of candidates in preclinical development
 Capacity and infrastructure developed or being
developed at several sites, including
outh Africa,
Kenya, Uganda, ozambique, thiopia,
enegal and
the Gambia
 anufacturing capacity being developed and
agreements explored, with particular emphasis on
emerging economies
 egulatory pathways and market/economic impact
research laying groundwork to accelerate adoption and
uptake of new TB vaccines
 AERAS GLOBAL TB VACCINE FOUNDATION

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 Improve BCG ‰ make a

recombinant rBCG

 rime-Boost regimen

 Give booster vaccinations in

infants

 Give booster vaccinations in

adolescents who have received
BCG at birth
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‡Recombinant protein vaccine intended to be a booster vaccine
‡Phase I clinical trials being conducted in Europe and Africa

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‡Recombinant protein vaccine intended to be a booster vaccine
‡Phase I and II trials conducted in Europe, Africa and Asia, including a Phase I trial in HIV+ in
Europe

 º 


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‡Viral vectored vaccine utilizing adenovirus 35; intended to be a booster vaccine
‡Phase I and II trials conducted in North America and Africa; Phase IIb recently initiated in HIV+ in
S. Africa
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‡Viral vectored vaccine utilizing modified vaccinia Ankara; intended to be a booster vaccine
‡The most clinically-advanced booster vaccine for tuberculosis with an ongoing proof-of-concept
Phase IIb trial in infants
‡Previous clinical trials in the UK and Africa, including in HIV+
‡Awarded orphan drug status by EMEA

‡ All vaccine candidates found to have acceptable safety profiles

‡ All candidates induced CD4+ and/or CD8+ T-cell responses to TB
antigens
‡ Immunogenicity results of booster candidates after BCG-priming are
encouraging for post-BCG prime-boost strategy
 AERAS GLOBAL TB VACCINE FOUNDATION

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 arge-scale community-based clinical

trials are conducted in high burden
countries

 Aeras partners with local research

institutions to establish field sites and
conduct clinical research

 Build local infrastructure and health

care/research capacity to perform future
Good Clinical ractice (GC) compliant
hase III clinical trials
 AERAS GLOBAL TB VACCINE FOUNDATION
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AERAS GLOBAL TB VACCINE FOUNDATION

% $
 artnership with
outh African Tuberculosis Vaccine Initiative (
ATVI)
 Field site developed in Worcester (~120 km from Cape Town) most
advanced site in the world for TB vaccine trials
 Infrastructure developed:
‰
tate-of-the-art immunology laboratory
‰ Highly skilled staff capable of performing the duties necessary to maintain the
infrastructure and execute clinical research
‰ Clinical and office facilities
‰ rofessional evelopment rogram (
iyantinga- ³each for the
tars´) ‰ over
230 staff trained since 2004
‰ esource Center
 $ %
AERAS 
GLOBAL TB VACCINE FOUNDATION

% $
 %$ is conducting hase I, II and
IIb studies of   vaccine candidates
in Worcester
 <conducted a
hase II clinical trial in adults with
active or previous TB in Cape Town
 $is enrolling adults
living with HIV in hase IIb trial in
Klerksdorp (mining community)
 †'$ 
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AERAS GLOBAL TB VACCINE FOUNDATION

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tate-of-the-art immunology and
mycobacteriology laboratory established in 
 ycobacterial lab capacity is being augmented in
†' and <
 ocal staff trained in clinical research in †'&
<and 
 pidemiological cohort studies in " &
& †'and <
 uality management and data management
infrastructure developed in and <
 New state-of-the-art Clinical esearch Center
established at a istrict Hospital in western †'

 First multicenter TB vaccine clinical trial initiated in

†'
 AERAS GLOBAL TB VACCINE FOUNDATION
   +
 etain local talent and expertise
 aise awareness about TB in the community

upport and enhance local clinical research capacity
 Community health and education
 Infrastructure remains in the community
 everage investment in infrastructure to use for clinical
trials of other diseases
 $$"'
 Future access considered at every stage of vaccine
development
 anufacturing
‰ Guarantee by partners for sufficient production and affordable
prices, or technology transfer
‰ anufactured by Aeras with partners in developing world
‰ Aeras will not consider vaccine candidates that will be costly to
manufacture on a large scale
 ricing
‰ ual pricing for affordable distribution in resource-poor countries
‰ Cost plus purchase from partner
‰ Aeras provides at cost
 istribution
‰ eveloping country governments
‰ International organizations (GAVI, UNICF)
‰ eveloping country partners
 AERAS GLOBAL TB VACCINE FOUNDATION

# Π

 arket study to analyze acceptability of 3
new pre-exposure vaccine scenarios
 6 respondents ‰ govt., providers, NGOs
 Interviews conducted in high TB burden
countries: Brazil, Cambodia, China, India,
ozambique, omania, ussia,
outh
Africa
 AERAS GLOBAL TB VACCINE FOUNDATION

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 Wide recognition that TB is serious and

neglected problem -TB threat
 Widespread dissatisfaction with current BCG
 ikely demand for partially effective vaccine
better than BCG
 Willingness to commit to rapid introduction
 F A or  A approval will speed adoption
 Willingness to spend money out of existing
budgets for prime-boost private sector
 AERAS GLOBAL TB VACCINE FOUNDATION

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A
 Clarify expected benefits (20-30 years)
 Fatalism about TB ‰ lack of political will
and competing priorities, e.g., HIV/AI

 Waiting for strong efficacy data, especially
in own country

ome resistance to adolescent boosting
(transient populations)

ome skepticism about aerosol delivery
 AERAS GLOBAL TB VACCINE FOUNDATION

 
 Heterogeneity of responses within and between
countries

trong efficacy data will be a critical success
factor for introduction, including in-country data
 Cost, if kept low, not likely to be major issue not
an issue in private markets
 ducation and preparation will be necessary, but
raising awareness and expectations too high
needs to be avoided
  <   
 
AERAS GLOBAL TB VACCINE FOUNDATION
- 7(1 !%8" !9

 WHAT: An update on the state of TB vaccine

development, outcomes from the recent global science
meeting on TB vaccines, and plans for the future.

 WHO:
‰ Kenyan TB Advocate ucy Ghati
‰ r. Joris Vandeputte, TBVI
‰ r. ew Barker, Aeras

 WH: ress Briefing oom 42

 WHN: 10 am - onday, 15 November

 AERAS GLOBAL TB VACCINE FOUNDATION

 
  





   

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