UPDATE 48: JANUARY 1 TO JANUARY 31, 2013
PDP FUNDERS GROUP
Items in blue or purple should be hyperlinked to the full text version; if I have made mistakes
many apologies. If you have any issues that you would like to include in the Update please
send them to Jane Rowley (jtfrowley@btinternet.com).
FUNDER ANNOUNCEMENTS (SINCE JANUARY 1, 2013)
Gates Foundation
30 January 2013:
2013 Annual Letter from Bill Gates
Today I am launching my Annual Letter. This year, I concentrate on the power of clear goals and
accurate measurement–simple concepts really–to improve the lives of the poorest people around the
globe. It may not be the sexiest of themes, but the proof of its impact is undeniable. The lives of the
poorest have improved more rapidly in the last 15 years than ever before. During that time, the
number of people living in extreme poverty has been reduced by half–extraordinary progress in a
short period of time. …
30 January 2013:
Gates Foundation Announces Winner of 2013 Gates Vaccine Innovation Award
Margarida Matsinhe recognized for her work making vaccines available to more
children in Mozambique
The Bill & Melinda Gates Foundation today announced the winner of the second Gates Vaccine
Innovation Award. The announcement was made in Bill Gates’ fifth annual letter, which provides his
personal account of the foundation’s priorities for the coming year.
The award recognizes the work of Margarida Matsinhe, a Mozambique-based field officer
for VillageReach, a social enterprise that works to increase access to healthcare for underserved
communities. Trained in public health, Ms. Matsinhe has helped increase access to vaccines for
thousands of children. Ms. Matsinhe played a key role in developing new approaches to improve the
logistics of vaccine delivery and collaborating with key partners to achieve Mozambique’s
immunization goals. …
US - NIH
23 January 2013:
NIH-Developed Candidate Dengue Vaccine Shows Promise in Early-Stage Trial
A candidate dengue vaccine developed by scientists at the National Institutes of Health has been
found to be safe and to stimulate a strong immune response in most vaccine recipients, according to
results from an early-stage clinical trial sponsored by the National Institute of Allergy and Infectious
Diseases (NIAID), part of the NIH. The trial results appeared in the January 17 issue of the Journal of
Infectious Diseases. …
The Phase I clinical trial, launched in July 2010 and led by principal investigator Anna Durbin, M.D., at
Johns Hopkins Bloomberg School of Public Health in Baltimore, tested a single dose of each of four
versions of the investigational dengue vaccine TetraVax-DV. The vaccine was developed by scientists
in NIAID’s Laboratory of Infectious Diseases. It is a live-attenuated vaccine, which means that the
viruses it contains are weakened enough such that they do not cause illness but still can induce an
immune response. Each of the four vaccines tested included different mixtures of components
designed to protect against all four dengue viruses. …
Wellcome Trust
3 January 2013:
Study turns parasite invasion theory on its head
Current thinking on how the Toxoplasma gondii parasite invades its host is incorrect, according to a
study published in ‘Nature Methods’ describing a new technique to knock out genes. The findings
could have implications for other parasites from the same family, including malaria, and suggest that
drugs being developed to block this invasion pathway may be unsuccessful.
UPDATE 48: JANUARY 1 TO JANUARY 31, 2013
17 January 2013:
Early HIV treatment slows damage to immune system
A 48-week course of antiretroviral medication taken in the early stages of HIV infection slows the
damage to the immune system and delays the need for long-term treatment, according to research
published today in the ‘New England Journal of Medicine’ (1). However, the delay was only marginally
longer than the time already spent on treatment.
31 January 2013:
Main causes of epilepsy in sub-Saharan Africa revealed
The largest study of epilepsy in Africa to date reveals that programmes to control parasitic diseases
and access to better antenatal care could substantially reduce the prevalence of the disease in this
region. …
PDP PRESS RELEASES (SINCE JANUARY 1, 2013)
FIND
7 January 2013:
FIND strengthens partnership with 42 Technology on major new diagnostic
programmes
The Foundation for Innovative New Diagnostics (FIND), which is driving the development and early
implementation of diagnostic tests for tuberculosis (TB), malaria and other diseases of the developing
world, has today confirmed an extension to its existing development partnership with 42 Technology
(42T). …
The consultancy has been appointed to work on a number of major new diagnostic projects involving
the development of very low cost and more effective tests that are simple and robust enough to be
used in challenging locations and closer to patients. The work will primarily benefit detection and
screening initiatives for the control and treatment of TB and malaria, diseases that together account
for more than two million deaths each year. However, a number of other ‘neglected’ infectious
diseases such as sleeping sickness, which have traditionally received little attention, are also expected
to benefit from this collaboration.
31 January 2013:
The Cochrane Library publishes new systematic review on Xpert MTB/RIF
Xpert® MTB/RIF can accurately and quickly detect both TB and drug-resistant strains, according to a
new study. The authors of the new systematic review assessing the diagnostic accuracy of the Xpert
test published in The Cochrane Library say their study can provide timely advice for clinicians and
policymakers in countries where TB is a major public health problem. …
IDRI
24 January 2013:
IDRI and Orangelife Register Rapid Diagnostic for Leprosy for Use in Brazil
IDRI (Infectious Disease Research Institute), in conjunction with OrangeLife, a Brazilian diagnostic
company, today announces the registration of a rapid diagnostic test for leprosy, offering new hope
for early diagnosis and treatment. The test was registered through ANVISA, Brazil’s regulatory
authority. …
According to Malcolm Duthie, Senior Scientist at IDRI, the diagnostic test is simple and easy to use.
“The test requires just a single drop of blood, mixed with a developing reagent,” he explained. “From
there, a line develops and it’s somewhat like a pregnancy test: the appearance of two lines indicates
the test is positive and the person has leprosy.” He added that scientific publications regarding the
rapid diagnostic indicate its ability to diagnose the presence of infection before clinical symptoms
appear, in most cases. …
MMV
7 January 2013:
UPDATE 48: JANUARY 1 TO JANUARY 31, 2013
MMV and partners handover SMS for Life in Tanzania to Government
MMV is pleased to announce that complete ownership of the SMS for Life programme in Tanzania
was transferred to the Ministry of Health and Social Welfare (MoHSW) on 1 January 2013.
SMS for Life, now fully implemented across the country, uses widely available mobile phone
technology to monitor antimalarial stock levels at healthcare facilities and pharmacies to prevent
stock-outs. Healthcare workers send weekly SMS messages to a central database, where the
information is used to facilitate rapid replenishment of stocks where required. …
PATH (including MVI and OWH)
7 January 2013:
PATH Malaria Vaccine Initiative and Inovio Pharmaceuticals partner to accelerate
development of malaria vaccines and innovative delivery technologies
The PATH Malaria Vaccine Initiative (MVI) and Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) today
announced a follow-on collaboration to advance malaria vaccine development and new vaccination
delivery technologies. Researchers will test whether a novel vaccine approach that combines
genetically engineered DNA with an innovative vaccine delivery technology called electroporation
could induce an immune response in humans that protects against malaria parasite infection. …
This follow-on agreement for clinical development builds on a 2010 research and development
collaboration between Inovio and MVI. Inovio researchers and their academic collaborators
developed novel DNA plasmids targeting multiple malaria parasite antigens and conducted studies in
rodents to demonstrate induction of broad immune responses. The success of these studies resulted
in an expanded collaboration, in which further testing demonstrated potent T cell and antibody
responses in other animal models. …
25 January 2013:
Dr. Anurag Mairal to lead technology solutions group
Dr. Anurag Mairal, an expert in product and market development, has been named global program
leader for Technology Solutions at PATH. Dr. Mairal will oversee research and development,
commercialization, and implementation of health technologies in the areas of maternal and neonatal
health, nutrition, water and sanitation, health management information systems, reproductive
health, vaccine-related technologies, and diagnostics for infectious and noncommunicable diseases. …
Sabin Vaccine Institute
17 January 2013:
Integrated Neglected Tropical Disease Control and Elimination Programs: A Global
Health ‘Best Buy’
A recently released report, entitled “Social and Economic Impact Review on Neglected Tropical
Diseases,” highlights links between neglected tropical diseases (NTDs) and socio-economic prosperity.
Published by Hudson Institute’s Center for Science in Public Policy, in partnership with the Global
Network for Neglected Tropical Diseases, an initiative of the Sabin Vaccine Institute, the paper found
NTD control and elimination efforts to be both inexpensive and highly effective, especially when
paired with other major disease treatment efforts, making NTD programs one of the most costeffective public health interventions available. …
30 January 2013:
John Cummins Joins the Sabin Foundation Europe Board of Trustees
Sabin Foundation Europe today announced the election of John Cummins, Group Treasurer of
the Royal Bank of Scotland, to the charity’s Board of Trustees. Mr. Cummins has more than 20 years
of experience in the treasury and finance industry, including serving as a Director of the International
Finance Facility for Immunisation Company (IFFIm) which has raised more than USD $4 billion for
vaccines for the developing world. …
TB Alliance
7 January 2013:
TB Alliance Announces TB Veteran Dr. Carlos Morel as Chairman of its Board of
Directors
The Global Alliance for TB Drug Development (TB Alliance) is pleased to announce the appointment of
UPDATE 48: JANUARY 1 TO JANUARY 31, 2013
Dr. Carlos Morel to Chairman of its Board of Directors. Dr. Morel is the Director of the Center for
Technological Development in Health (CDTS) of the Oswaldo Cruz Foundation (FIOCRUZ), a scientific
institution dedicated to public health, biomedical research and development located in Brazil, a high
TB burden country. …
TB Alliance also announces the appointment of Dr. Jaap F. Broekmans as Vice-Chairman of its Board
of Directors. Dr. Broekmans is currently Chair of WHO's Global Task Force on TB Impact Measurement
(since 2007) and Adjunct Professor, Epidemiology, at the Johns Hopkins Bloomberg School of Public
Health. …
11 January 2013:
Improving the Therapeutic Potential of Pyrazinamide
Pyrazinamide (PZA) is an incredibly important sterilizing agent in the treatment of tuberculosis and is
considered responsible for reducing the duration of treatment from the previous 9-12 months, to the
current short-course of 6 months produced by the standard regimen (HRZE).Beyond its contribution
in the current first-line regimen, the TB Alliance, through its ongoing novel regimen development
program is finding that PZA is critical to any treatment shortening regimen, including those that
contain newer agents currently in clinical development. PZA has the ability to synergize with other
drugs and this synergy drives the treatment-shortening potential of experimental regimens, such as
PaMZ (PA-824 + moxifloxacin + pyrazinamide) currently under clinical development. However,
resistance to PZA is on the rise, creating potential problems for PZA-containing regimens in
development. Yet, there may be ways to circumvent this resistance. Investigating whether this is
possible is the focus of a 1-year, $250,000 grant from the US NIH ACTG. …
TBVI
14 January 2013:
Financial support for two vaccine candidates
The vaccine candidates MTBVAC, developed by the University of Zaragoza and produced by BIOFABRI,
and HBHA, developed by Institute Pasteur Lille and produced in collaboration with AERAS, have been
awarded with financial support for further development. BIOFABRI will receive $ 430,000 to support
a PhaseI clinical trial carried out by Centre Hospitalier Universitaire Vaudois, Lausanne. Institut
Pasteur Lille, will receive $ 350,000 for HBHA to fund GMP production of HBHA and studies to select
an adjuvant. …
15 January 2013:
Open call for application TB vaccine evaluation
… The current call for applications focuses on testing the protective efficacy of new vaccine
candidates, formulations or delivery systems in a guinea pig experiment. Up to 8 vaccine slots are
available. The proposed vaccine candidates will be judged by a Selection Panel whose members are
independent of laboratories that may apply for slots in the guinea pig experiments. After a selection
has been made, the candidates may be grouped into appropriate experimental schedules that will
enable the most suitable use of challenge dose, control groups, and most efficient use of the facilities.
Motivated applications can be sent to TBVI before 17:00 CEST, 10 May 2013.
RECENTLY RELEASED PDP REPORTS/ BRIEFING PAPERS/ ARTICLES
Articles in Peer Reviewed Journals
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Induction and Regulation of T Cell Immunity by the Novel TB Vaccine M72/AS01 in South
African Adults. Day CL et al. Am. J. Respir. Crit. Care Med. .January 10, 2013rccm.2012081385OC
Shark variable new antigen receptor (Vnar) single domain antibody fragments: stability and
diagnostic applications. Griffiths K et al. Antibodies 2013, 2(1), 66-81;
doi:10.3390/antib2010066
Genomic analysis of smooth tubercle bacilli provides insights into ancestry and pathoadptation
of Mycobacterium tuberculosis. Supply P et al. Nature Genetics(2013) doi:10.1038/ng.2517
Reducing Stock-Outs of Life Saving Malaria Commodities Using Mobile Phone Text-Messaging:
SMS for Life Study in Kenya. Githinji S et al. PLoS ONE 8(1): e54066.
doi:10.1371/journal.pone.0054066.
UPDATE 48: JANUARY 1 TO JANUARY 31, 2013
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Development and pre-clinical assessment of a 73kD chimeric fusion protein as a defined subunit vaccine for leprosy. Duthie MS et al. Vaccine. January 2013.
Other PDP Publications/ Briefing papers
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Costing Dengue Cases And Outbreaks: A Guide To Current Practices And Procedures. Armien B et
al. IVAC. December 2012.
RECENTLY RELEASED PDP RELATED REPORTS/ BRIEFING PAPERS/ ARTICLES
Reports/ briefing papers/ books
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Sustaining the drive to overcome the global impact of neglected tropical diseases. WHO January
2013.
From Promises to Progress: The First Annual Report on the London Declaration on NTDs. Uniting
to combat NTDs. January 2013.
Strengthening Mechanisms to Prioritize, Coordinate, Finance, and Execute R&D to Meet Health
Needs in Developing Countries. IOM Discussion Paper. January 2013.
Future of PrEP and Microbicide Research: Trial Design and Regulatory Issues. Forum for
Collaborative HIV Research. Materials from a meeting held January 7, 2013.
USAID: Report to Congress: Health-related research and development strategy. 2011-2015.
December 2012.
PDP RELATED NEWS/ ARTICLES (SINCE JANUARY 1, 2013)
HIV/AIDS
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Malaria
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TB
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10 January: New Insights Into HIV Vaccine Will Improve Drug Development
10 January: GeoVax announces enrollment completion for phase 1/2 clinical trial
for HIV/AIDS therapeutic vaccine
11 January. HIV Vaccines: New insight for researchers
17 January: HIV trial under scrutiny
28 January: DNA vaccine tattoo triggers HIV immune response
A tale of two vaccines: Lessons from polio that could inform the development of an
HIV vaccine. Esparza J. AIDS. 2 January 2012
Combination implementation for HIV prevention: moving from clinical trial
evidence to population-level effects. Chang LW et al. The Lancet Infectious
Diseases, Volume 13, Issue 1, Pages 65 - 76, January 2013
'It looks like you just want them when things get rough': Civil society perspectives
on negative trial results and stakeholder engagement in HIV prevention trials.
Koen J et al. Developing World Bioethics. 25 January 2013:1471-8847.
Vaccine induction of antibodies against a structurally heterogeneous site of
immune pressure within HIV-1 envelope protein variable regions 1 and 2. Liao H et
al. Immunity. 10 January 2013
MTN-001: Randomized pharmacokinetic cross-over study comparing tenofovir
vaginal gel and oral tablets in vaginal tissue and other compartments. Hendrix C et
al. PLoS One. 31 January 2013
The ongoing quest for malaria vaccines. Hayward P. The Lancet Infectious Diseases,
Volume 13, Issue 1, Pages 21 - 22, January 2013
Malaria and lymphatic filariasis: the case for integrated vector management. van
den Berg H et al. The Lancet Infectious Diseases, Volume 13, Issue 1, Pages 89 - 94,
January 2013
3 January: FDA approval of new TB drug benefits patients and highlights the
agency’s lifesaving programs
17 January: Hudson Institute and Global Network Report: NTDs a “Best Buy” in
Global Health
Intensified regimen containing rifampicin and moxifloxacin for tuberculous
meningitis: an open-label, randomised controlled phase 2 trial. Rulami R et al. The
Lancet Infectious Diseases, Volume 13, Issue 1, Pages 27 - 35, January 2013
Assessment of the Xpert MTB/RIF assay for diagnosis of tuberculosis with gastric
UPDATE 48: JANUARY 1 TO JANUARY 31, 2013
NTDs
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Vaccines
Other
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lavage aspirates in children in sub-Saharan Africa: a prospective descriptive study.
Bates M et al. The Lancet Infectious Diseases, Volume 13, Issue 1, Pages 36 - 42,
January 2013
16 January: Global Partners Making Progress Against Neglected Tropical Diseases,
New Report and Scorecard Show
16 January: WHO heralds “new phase” in the fight against neglected tropical
diseases
16 January: Somewhat less neglected tropical diseases
30 January: New research centre to tackle NTDs
22 January: European Commission approves Novartis' meningitis B vaccine, Bexsero
A single dose of any of four different live attenuated tetravalent dengue vaccines is
safe and immunogenic in flavivirus-naïve adults: a randomized, double blind clinical
trial. Durbin AP et al. J Infect Dis. (2013). doi: 10.1093/infdis/jis936. First published
online: January 17, 2013
8 January: The Evolving Role of the Private Sector in Global Health
24 January: EDCTP and EFPIA sign memorandum of understanding on a Clinical
Research Fellowship Scheme for sub-Saharan Africa
28 January: Debate Erupts At WHO Over “Consensus” On Financing R&D For The
Poor
UK investments in global infectious disease research 1997–2010: a case study. Head
MG et al. The Lancet Infectious Diseases, Volume 13, Issue 1, Pages 55 - 64, January
2013
Global paediatric advanced life support: improving child survival in limited-resource
settings. Ralston ME et al. The Lancet, Volume 381, Issue 9862, Pages 256 - 265, 19
January 2013
ONGOING CONSULTATIONS
FDA posts draft microbicide guidance for public comment
The U.S. Food and Drug Administration (FDA) is seeking public comment on its newly-posted draft
guidance for industry, entitled "Vaginal Microbicides: Development for the Prevention of HIV
Infection." The purpose of the guidance is to assist sponsors in all phases of microbicide development.
It outlines the types of nonclinical studies and clinical trials recommended throughout the drug
development process to support approval of vaginal microbicides for prevention of human
immunodeficiency virus (HIV). The FDA welcomes comments on this guidance until February 21, 2013.
The guidance document is available at:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm328834.htm
UPCOMING MEETINGS
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February 20 2013: IAVI Donors Meeting. London
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February 26 2013: EVI 15th Anniversary Symposium. Heidelberg. Germany.
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March 25-27: Third Global Forum on TB Vaccines. Cape Town, South Africa
October 20-24 2013: Seventh EDCTP Forum. Dakar, Senegal.
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