tb and hiv/aids (peg willingham)
TRANSCRIPT
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TB & HIV/AIDS
Peg Willingham, Senior Director for External Affairs
Aeras Global TB Vaccine Foundation
JOURNALIST to JOURNALISTGlobal Media Training Program on HIV/AIDS
Vienna, AustriaJuly 15, 2010
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AERAS GLOBAL TB VACCINE FOUNDATION
The Tuberculosis Pandemic
TB is spread froman infectiousperson to avulnerable person
through the air
TB usually affectsthe lungs (80% ofcases) but canaffect any part ofan infected person
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The TB Pandemic
The World Health Organization (WHO)
estimates that in 2008:
9.4 million new cases of TB were
diagnosed
1.8 million people died from TB
One out of three people in the world havebeen infected with TB (although most do
not develop disease)
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Estimated TB Incidence Rate, 2007
Estimated new TB cases (all
forms) per 100 000 population
The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health
Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.
Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.WHO 2009. All rights reserved
No estimate
0-24
50-99
>= 300
25-49
100-299
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The TB Pandemic
TB is the worlds 2nd most deadly infectious disease in
adults, after HIV/AIDS, and one of leading causes of
death globally.
TB is curable, but treatment is lengthy often spanning
6 months to a year and is not available to all.
Drug-resistant TB is expensive, even more lengthy,
and difficult.
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What Drives the TB Epidemic?
Poverty
Malnutrition
Overcrowded livingconditions
Slums 1 billion and growing
Smoking Diabetes
HIV
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No estimate
04
2049
>= 50
519
HIV prevalence in
TB cases, (%)
The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health
Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.
WHO 2009. All rights reserved
HIV Prevalence Among TB Cases, 2007
mate: about 1.4 million TB/HIV cases and 450,000 TB/HIV deat
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The HIV/AIDS Pandemic
UNAIDS and WHO estimate that in 2008:
33.4 million people living with HIV; 67%
in Sub-Saharan Africa
2.7 million new HIV infections worldwide
2 million AIDS-related deaths
http://images.google.com/imgres?imgurl=http://scrapetv.com/News/News%2520Pages/Health/Images/aids-ribbon.jpg&imgrefurl=http://scrapetv.com/News/News%2520Pages/main%2520pages/Health.html&usg=__TJve7rJyJv3L5uWK7zXLuY6I2aQ=&h=418&w=300&sz=31&hl=en&start=2&sig2=BBWN3lQ6dgDFHGM3_8OjGQ&tbnid=OWH3v6z6eIIbpM:&tbnh=125&tbnw=90&prev=/images%3Fq%3DAIDS%2Bribbon%26gbv%3D2%26hl%3Den&ei=02dCSsTUBNTklAfQ-I2lCQ -
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The HIV/AIDS Pandemic
HIV/AIDS is the worlds most deadly
infectious disease killing more than 25
million people since the disease was
first recognized in 1981
Despite years of research, there is stillno cure or vaccine for HIV/AIDS
http://images.google.com/imgres?imgurl=http://scrapetv.com/News/News%2520Pages/Health/Images/aids-ribbon.jpg&imgrefurl=http://scrapetv.com/News/News%2520Pages/main%2520pages/Health.html&usg=__TJve7rJyJv3L5uWK7zXLuY6I2aQ=&h=418&w=300&sz=31&hl=en&start=2&sig2=BBWN3lQ6dgDFHGM3_8OjGQ&tbnid=OWH3v6z6eIIbpM:&tbnh=125&tbnw=90&prev=/images%3Fq%3DAIDS%2Bribbon%26gbv%3D2%26hl%3Den&ei=02dCSsTUBNTklAfQ-I2lCQ -
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HIV/AIDS and TB:
A Deadly Combination
HIV suppresses the human immune system
TB suppresses the human immune system Each makes the other worse synergistically
The number of new cases of TB has more than doubled incountries with high HIV prevalence in the past 15 years
Onein
fou
rHIV
dea
ths
islinke
dto
TB
+
http://images.google.com/imgres?imgurl=http://scrapetv.com/News/News%2520Pages/Health/Images/aids-ribbon.jpg&imgrefurl=http://scrapetv.com/News/News%2520Pages/main%2520pages/Health.html&usg=__TJve7rJyJv3L5uWK7zXLuY6I2aQ=&h=418&w=300&sz=31&hl=en&start=2&sig2=BBWN3lQ6dgDFHGM3_8OjGQ&tbnid=OWH3v6z6eIIbpM:&tbnh=125&tbnw=90&prev=/images%3Fq%3DAIDS%2Bribbon%26gbv%3D2%26hl%3Den&ei=02dCSsTUBNTklAfQ-I2lCQhttp://images.google.com/imgres?imgurl=http://scrapetv.com/News/News%2520Pages/Health/Images/aids-ribbon.jpg&imgrefurl=http://scrapetv.com/News/News%2520Pages/main%2520pages/Health.html&usg=__TJve7rJyJv3L5uWK7zXLuY6I2aQ=&h=418&w=300&sz=31&hl=en&start=2&sig2=BBWN3lQ6dgDFHGM3_8OjGQ&tbnid=OWH3v6z6eIIbpM:&tbnh=125&tbnw=90&prev=/images%3Fq%3DAIDS%2Bribbon%26gbv%3D2%26hl%3Den&ei=02dCSsTUBNTklAfQ-I2lCQ -
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TB/HIV Co-infection
TB is the leading cause of death PLWHA in Africa and amajor cause elsewhere
TB is the most common presenting illness among people
living with HIV on ARV treatment worldwide
1.4 million of the new TB cases in 2008 were in peopleliving with HIV; 78% in the African Region
500,000 people died of HIV associated TB in 2008
+
http://images.google.com/imgres?imgurl=http://scrapetv.com/News/News%2520Pages/Health/Images/aids-ribbon.jpg&imgrefurl=http://scrapetv.com/News/News%2520Pages/main%2520pages/Health.html&usg=__TJve7rJyJv3L5uWK7zXLuY6I2aQ=&h=418&w=300&sz=31&hl=en&start=2&sig2=BBWN3lQ6dgDFHGM3_8OjGQ&tbnid=OWH3v6z6eIIbpM:&tbnh=125&tbnw=90&prev=/images%3Fq%3DAIDS%2Bribbon%26gbv%3D2%26hl%3Den&ei=02dCSsTUBNTklAfQ-I2lCQ -
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TB Drug Resistance
WHO estimates 490,000 MDR-TB cases emerge everyyear, with more than 110,000 deaths
Extensively drug-resistant (XDR) TB has been identified in
57 countries as of November 2009
In 2008, WHO reported that the highest rates of MDR TBever recorded, with peaks of up to 22% of new TB cases,were in some settings of the former Soviet Union. In the
same region, 1 in 10 cases of MDR-TB is XDR-TB
Treatment for drug-resistant TB is much longer, morecomplex and more expensive - with much lower successrates
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TB/HIV A Human Rights Issue
No vaccine to provide long-term protection frompulmonary TB
No HIV vaccine
No benefit from biomedical advances for people andcommunities affected by TB
TB exposure due to inadequate health systems poordelivery of INH prophylaxis
TB and HIV diagnostics inadequate for testing children
Poor pediatric tracking programs to measure incidence
Social circumstances lead to exposure poverty,malnutrition
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Maternal TB/HIV important risk factor for
pediatric TB and mortality Estimated TB rate:
-10 times higher in HIV-exposeduninfected children
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Why do we need new tools for TB/HIV?
Diagnostics - More than 100 years old Particularly ineffective for diagnosing TB in people with
HIV/AIDS
Newer, more effective methods are not widely used Tests for drug-resistant strains not widely available in the field
Diagnostics suitable for community level still do not exist
Drugs - More than 40 years old Four drugs, taken for 6-9 months Not compatible with some HIV/AIDS antiretrovirals Treatment for resistant strains lengthy, expensive and toxic
with lower success rates
Vaccine - More than 85 years old Unreliable protection against pulmonary TB or past infancy Not safe for use in infants infected with HIV
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Barriers to Research & Development
of New Tools
Scientific uncertainty
Market uncertainty
Too much risk relative to perceived gain forprivate sector
Lack of clinical trial and manufacturing capacity
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AERAS GLOBAL TB VACCINE FOUNDATION
Addressing Barriers through
Product Development Partnerships (PDPs) Non-profit enterprises created to accelerate R&D for new products to
fight AIDS, TB, malaria and other neglected diseases
Manage resources and partnerships from across public, private andphilanthropic sectors
Complements partners expertise, facilities and capacity
Utilize a portfolio management approach
Act as a catalyst to advance new products through the developmentpipeline towards registration and launch
Range from virtual to bricks and mortar depending on availabilityof external capacity
Commitment to access, availability and affordability
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New Tools: Target Product Profiles
Drugs: new affordable TB drugs that will dramatically
shorten treatment time, work against drug-resistant TB,
be compatible with HIV antiretrovirals and improve
treatment of latent TB. Diagnostics: rapid, accurate and affordable TB tests and
point-of-care diagnostics to more efficiently detect TB and
drug-resistant forms of TB.
Vaccines: new, safe, effective and affordable vaccine
regimens to protect against all forms of TB MDR and
XDR, to prevent TB in children, adolescents and adults,
and to be safe for use in people infected with HIV
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AERAS GLOBAL TB VACCINE FOUNDATION
New Tools In the Pipeline
Available Now:
1st Wave of Innovation
Point of care diagnostic(detects resistance?Better for use in peoplewith HIV?)
New drug 4-month drugregimen which can beadministered with ARVsand is active againstdrug-resistant TB
Holy grail diagnostic
Significantly shorter (lessthan 2 months) TBregimen
New TB vaccine that willprevent all forms of TB inall age groups and will besafe for use in peoplewith HIV
New diagnostic availablefor peripheral lab settings{specify}
New diagnostic availablefor referral lab settings{specify}
2015 and beyond:3rd Wave of Innovation
2012 - 2015:2nd Wave of Innovation
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2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Dista
ncefrom
Patients
95%
Peripheral Lab
First Referral Level
70%
10-40%
%
Accessaf te
r5
years
Rapidculture&DST
Automa
tedNA
AT
(detect
ion&D
ST)
Manua
lNAAT
(DST)*
Improved
microscopy
Manu
alNAA
T
(detection
)
***
Predictive
LTBI
Rapid
speciation
POCtest
(detection)
Non-comm
ercial
cultureme
thods
Rapidc
olorime
tricDS
T
Community HealthCare
Manual
NAAT
(detec
tion)**
Abbreviations
DST: Drug Susceptibility TestNAAT: Nucleic AcidAmplification TestLTBI: Latent TB InfectionPOC: Point of Care
* Manual NAAT: technology for MTB Drug Susceptibility Testing (Line Probe As
* * Manual NAAT: technology for MTB detection at the Peripheral Lab* * * Manual NAAT: technology for MTB detection at the Community Health Care
Technologies in boxes: endorsed byWHO
Diagnostics Pipeline
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Partner Sites for TB Diagnostic Trials>50 trial sites in 25 countries
18 sites in Africa, 19 in Asia, 7 in Americas, 8 in Europe
Office in India and Uganda
MOUs with >17 MOH & NTP Strong partnerships with international agencies
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The Global Drug PortfolioTesting combination regimens with multiple new drugs
Bayer,
TB Alliance
Oflotub,
TDR
J&J/Tibotec
Otsuka
TB Alliance
Sequella
Lupin
Pfizer
Phase I Phase II Phase III
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TB Alliance Clinical Sites for New TB Drugs
Mexico
Peru
Kenya
Korea
Delhi
South Africa (5)
Taiwan
Hong Kong
Thailand (3)Malaysia
China (3)
Tanzania (2)
Zambia
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Global TB Vaccine Pipeline
Additional research at the discovery/early pre-clinical level: Bhagawan Mahavir Medical Research Center; Cardiff University; EpiVax, Inc.; ImmunoBiology Ltd.; Infectious Disease ResearchInstitute; Institute de Pharamacologie, Puso; Karolinska Institute; Malaysia-Finlay Institute, NIAID; NIH; Osaka University; Shanghai H&G Biotech; Sequella; UCLA; and, Vanderbilt University.
AERAS402/Crucell Ad35
Crucell N.V./Aeras
MVA85A/AERAS-485OETC/Aeras
kingGroup
onNewTBVaccines
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Aeras Partnerships for Field Research
/UCT
,Sou
thAfrica
Makere r
eUniversity,U g
anda
KEMRI/CDC,Ke
nya
StJohn s
Researc
h
Institut e
,Ind
ia
C
ambod
ianHealth
Co
mmit
tee,Cambodia
anhica
Health
ResearchCen
tre
Mozambiqu
e
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Existing TB Vaccine Ineffective
BCG unreliable against pulmonary TB,which accounts for most TB diseaseworldwide
BCG is not know to protect against latent TB
BCG is not recommended for use in infantsinfected with HIV - increased risk for severeBCG-related complications
Despite wide use, BCG has had no apparentimpact on the growing global TB epidemic
BCG does reduce risk of severe pediatric TBdisease, so it should continue to be useduntil a better TB vaccine is available
BCG
introduced
in1921
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Tuberculosis: TB Vaccine Too Dangerous
for Babies With AIDS Virus, Study Says
July 2, 2009 The vaccine against tuberculosis that is
routinely given to 75 percent of the worlds infants is
too risky to give to those born infected with the AIDS
virus, says a new study published by the World HealthOrganization. It recommended that vaccination be
delayed until babies can be tested.
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WHO 2007 Recommendations on BCG
Children with HIV infectionregardless of symptoms should notbe BCG vaccinated
All high risk infants need HIV
screening Maternal antibody masks antibody
tests Detection of virus required Very difficult to implement in many
places
HIV
infecte
dinfantsrec
ently(200
9)
estima
ted
00
(He
sseling,et
al )
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AERAS GLOBAL TB VACCINE FOUNDATION
Goals for Better TB Vaccines
Eliminate TB as a public health
threat, in line with global targets
(
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Aeras Global TB Vaccine Foundation
MissionTo develop new, more effective TBvaccines and ensure their availability toall who need them
Method
Collaborate with academic, biotech,pharmaceutical and NGO partners todevelop and test new TB vaccines
Purse a Prime-Boost strategy bydeveloping a modern replacement forBCG plus booster vaccines
Develop vaccines in its own lab andmanufacturing plant
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Approach to a New TB Vaccine
Improve BCG make a
recombinant rBCG
Prime-Boost regimen
Give booster vaccinations in
infants
Give booster vaccinations in
adolescents who have received
BCG at birth
G
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Safer in HIV infected infants orothers with immune-suppression
BCG or rBCG boosted with another
TB vaccine is much better than
either vaccine alone Constructed to address each stage
of the TB life cycle
Prevent infection and reactivation
A new vaccine candidate with all of
these properties is expected to
enter clinical trials in 2010
R
ecomb in
antBCG
(rBCG
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Aeras TB Vaccine Candidates in Clinical Trials
Potential Boost Vaccines
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
SSI HyVac4 / AERAS-404 Status: Phase IRecombinant protein vaccine intended to be a booster vaccine
Phase I clinical trials being conducted in Europe and Africa
GSK M72 Status: Phase II
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
EuropeAERAS-402 / Crucell Ad35 Status: Phase IIb
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+ inS. Africa
MVA85A / AERAS-485 Status: Phase IIb
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-conceptPhase IIb trial in infants
Previous clinical trials in the UK and Africa, including in HIV+
Awarded orphan drug status by EMEA
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Clinical Trials Field Site Development
Large-scale community-based clinicaltrials are conducted in high burdencountries
Aeras partners with local researchinstitutions to establish field sites andconduct clinical research
Build local infrastructure and health
care/research capacity to perform futureGood Clinical Practice (GCP) compliantPhase III clinical trials
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Example of Site Development
South Africa Partnership with South African Tuberculosis Vaccine Initiative (SATVI) Field site developed in Worcester (~120 km from Cape Town)
Infrastructure developed:
State-of-the-art immunology laboratory
Highly skilled staff capable of performing the duties necessary to maintain theinfrastructure and execute clinical research
Clinical and office facilities
Professional Development Program (Siyantinga- Reach for the Stars) program initiated in 2001
Resource Center established in 2005
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Activities in South Africa - SATVI
Research Partner - South African Tuberculosis Vaccine
Initiative (SATVI)
Conducting Phase I, II and IIb studies offourvaccine
candidates
Adult and infant enrollment Over 230 staff trained since 2004
Most advanced site for large-scale TB vaccine trials in the
world
Future infant studies planned of AERAS-402/Crucell Ad35
Western Cape
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Activities in South Africa - UCT Lung Institute
Research Partner University of
Cape Town Lung Institute
Phase II clinical trial in adults with
active or previous TB (AERAS-402/Crucell Ad35 )
Cape Town
Future study of TB vaccine
candidate in HIV infected adults
planned (part of multi-centerMVA85A/AERAS-485 study)
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Activities in South Africa Aurum Institute
Research Partner Aurum Institute Enrolling adults with HIV in Phase IIb trial
Safety and efficacy of TB vaccine (MVA85A/AERAS-485)
Klerksdorp, North West (mining area)
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Key Accomplishments at Other Partner Sites
State-of-the-art immunology andmycobacteriology laboratory established inIndia
Mycobacterial lab capacity is being augmentedin Kenya and Uganda
Local staff trained in clinical research inKenya, Uganda and India
Epidemiological cohort studies in Cambodia,India,Kenya and Uganda
Quality management and data managementinfrastructure developed in India and Uganda
Vaccine trials being conducted in Kenya
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Local Benefits of Clinical Research
Retain local talent and expertise
Raise awareness about TB in the community
Support and enhance local clinical research capacity
Community health and education
Infrastructure remains in the community
Leverage investment in infrastructure to use for clinical trials of
other diseases
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Building Manufacturing Capacity
Reduce the cost and time tomanufacture and deliver vaccines to allwho need them
Produce enough bulk doses of vaccine
to meet the worlds estimated need Work with partners in countries such
as India, China, Korea and SouthAfrica to produce, fill, finish anddistribute vaccines at the lowest
possible price Ensure uniformity of quality
Minimize lag time between licensureand distribution
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Summary
New TB vaccines, drugs and diagnostics
will help achieve global development goals
are critical to controlling TB pandemic
will reduce the cost and burden of TB on patients, health caresystems and national economies
PDPs are leading the effort to develop new TB tools that will beaffordable and accessible worldwide, engaging stakeholders from acrosssectors toward common goals
Research collaborations in TB endemic countries build and strengthenresearch capacity, and are critical to advancing product candidates
New tools need to be a global priority to help ensure rapid developmentand distribution
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AERAS GLOBAL TB VACCINE FOUNDATION
Aeras gratefully acknowledges the support of
the following major donors
NetherlandsMinistryofForeignAffairs
THE MARY LYNN
RICHARDSON
FUND