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Dear friends of the PATH Malaria Vaccine Initiative,
November is always a busy month for the MVI team, but this November was unusually so, given this year's ASTMH meeting in New Orleans and the holding of our annual Vaccine Science Portfolio Advisory Council meeting in Washington, DC. These important meetings coincided with the announcement of a five-year, US$156 million grant for the MVI program from the Bill & Melinda Gates Foundation, which came not long after a second award to MVI from Japan’s Global Health Innovative Technology Fund was announced in September. The last several months have also seen the
submission of the RTS,S malaria vaccine candidate to the European Medicines Agency by our partner GlaxoSmithKline and the completion of several challenge trials for other vaccine candidates undertaken in collaboration with the University of Oxford, the Walter Reed Army Institute of Research, and others.
Other developments here at MVI include the addition of some key new team members, including Rick King as director of research and development (R&D) and Shwu-Maan Lee as a senior program officer overseeing process development and manufacturing activities. Rick’s arrival in particular affords me more time to focus on the role I assumed just over a year ago as director of the MVI program overall.
A time for giving thanks and looking to the future
Thinking about the developments of the last half year, I can only be thankful for the continued support of our funders and the collaboration of our R&D partners. MVI is a “virtual” vaccine developer on the continuum of product development partnership models; our success hinges upon our ability to successfully convene partners, advance productive collaborations, and ensure data-driven decisions. We also depend upon the strengths and abilities of the partners with whom we work. Whether from private industry, government agencies, or other non-profits working in research and development, our partners are the lifeblood of our success.
Sustained funding is another key factor in our continued progress. This year marks 15 years since an initial grant from the Bill & Melinda Gates Foundation made possible the establishment of the MVI program at PATH. We also mark a decade of support from the ExxonMobil Foundation and have recently come to the end of a ten-year cooperative agreement with the US Agency for International Development. These kinds of long-term funding relationships are crucial to our success given the high-risk and high-cost work of developing vaccines against malaria.
Which brings us to the future.
Even as the RTS,S vaccine candidate wends its way through regulatory review, MVI is already working to build a “next generation” of vaccines that will interrupt the cycle of malaria parasite transmission and help realize the “accelerating to zero” agenda. Such vaccines would go beyond preventing malaria illness to preventing infection and transmission of the parasite.
People living in regions affected by malaria often develop natural immunity, and while they may not show symptoms of malaria following subsequent infections, they often harbor parasites and transmit them to mosquitoes, which in turn infect other people. To accelerate future elimination and eradication efforts, vaccines are needed that induce immunity to prevent humans from becoming infected and to shrink the human parasite reservoir. MVI’s two-pronged strategy is to develop vaccines that prevent people from becoming infected after being bitten by infected mosquitoes (anti-infection vaccines) and that prevent mosquitoes from becoming infected, even after feeding on an infected person (transmission-blocking vaccines). Vaccines that combine these two attributes will be of particular focus. Read more in this
press release.
As we implement this ambitious strategy, we are conscious of our role in an emerging malaria eradication ecosystem. We are not working in isolation, but collaborating with others to ensure that we understand how any vaccine would be implemented, together with other interventions, even before they are developed. And we are working in partnership. Looking beyond the multiple collaborations that are contributing to the development of RTS,S for pediatric use, MVI is currently working with more than 50 partners worldwide—and we hope to work with even more.
It is the season to be thankful, to reflect on the year past, and to prepare for the year to come. On behalf of the entire MVI team, I send you our thanks for your interest in our work and look forward to hearing from you this year and next.
Best wishes for the holiday season,
Ashley Birkett
PATH Malaria Vaccine Initiative
mvi_info@path.org
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Japan's GHIT Fund announces award to MVI
 The PATH Malaria Vaccine Initiative (MVI) welcomed an announcement on September 16 by Japan’s Global Health Innovative Technology (GHIT) Fund of a grant of US$766,000 to MVI and its partner Ehime University to fast-track the development of a novel malaria vaccine candidate, Pf75.
This award is the second grant to MVI from the GHIT Fund.
Read More »
Biting back? Immunize mosquitoes
In 1897, British doctor Sir Ronald Ross discovered that malaria in people is transmitted to and from mosquitoes. Dr. Ross went on to win the Nobel Prize for his discovery, and since then, mosquitoes have been enemy number one when it comes to defeating a disease that takes a life every single minute—most of them young children in sub-Saharan Africa.
Since then, the malaria community has continued to innovate and improve methods to control the disease. In the vaccine field, the community has begun to focus on approaching malaria in a surprising new way: with a vaccine to protect malaria-transmitting mosquitoes. Put another way, such a vaccine would stop humans from giving malaria-causing parasites to mosquitoes.
Read More »
RTS,S submitted to European regulatory authority
 GlaxoSmithKline (GSK) announced on July 24 that it had submitted a regulatory application to the European Medicines Agency (EMA) for the RTS,S malaria vaccine candidate. The PATH Malaria Vaccine Initiative has been in a unique public-private partnership with GSK since 2001 to develop and test RTS,S for use among young children and infants in sub-Saharan Africa, who account for most of the more than 600,000 annual worldwide deaths from the disease. To date, there is no licensed vaccine for the prevention of malaria.
Announcement of the regulatory application followed conclusion of the large-scale Phase 3 trial of RTS,S at 11 trial sites in seven African countries. The data from this and related studies provide the basis for consideration by the EMA. If the EMA grants a positive opinion on RTS,S, the World Health Organization has indicated that a policy recommendation for the malaria vaccine candidate is possible as early as 2015, paving the way for African nations to decide on implementation through their national immunization programs.
Read More »
Direct Membrane-Feeding Assay Workshop
In an effort to build the capacity of laboratory technicians and entomologists working in malaria vaccine development in Africa, the PATH Malaria Vaccine Initiative (MVI) supported a five-day workshop in Yaoundé, Cameroon in October. Led by 11 scientists and attended by 12 researchers, the workshop aimed to train researchers on direct membrane-feeding assays to assess the efficacy of parasite transmission-blocking interventions. Two MVI scientists, Emily Locke, PhD, MPH, and Diadier Diallo, PhD, MSc—both working with partners to identify and validate assays that are predictive of protection in the field—traveled to Cameroon to help facilitate the workshop, which was hosted and organized by L’Institut de Recherche pour le Développement
and Organisation de Coordination pour la lutte contre les Endémies en Afrique Centrale.
Participants from Cameroon, The Gambia, Kenya, Mali, Tanzania, and Uganda attended lectures and laboratory sessions on mosquito rearing, membrane feeding, mosquito dissection, and oocyst detection through microscopy and immunological methods. To further strengthen the technicians’ research skills, trainers also provided instruction on data collection, analysis, and report writing. Workshop organizers set up an informal communication channel that has allowed participants to collaborate with each other since returning to their respective institutions, and plans for follow-up activities and meetings to further build upon what these technicians learned are in the works.
Read more »
Interview with Rick King, MVI R&D Director
 Rick King, PhD, joined the PATH Malaria Vaccine Initiative (MVI) in May as director of research and development (R&D) and head of the transmission-blocking vaccine program, one of two product development priority areas at MVI. We recently sat down with Rick to learn about what motivates him to work in vaccine development. Excerpts from the conversation are below; the complete interview can be found on our website.
What do you like most about your work as MVI’s R&D director?
I have a fascination with biological systems and with intervening in those systems to generate a therapeutic or intervention of some kind—diagnostic or preventative. It’s an exciting challenge and one that I find intriguing to be part of.
How did you become interested in vaccine development?
I’d been involved in very basic biochemical and molecular biological research for a long time—since the 1980s—and it was quite early in my career when I became interested in applications related to these areas.
Could you expand on your interest in developing malaria vaccines specifically?
I think the thing that is really exciting about malaria vaccines now is the prospect of success. We have evidence in human clinical trials that malaria vaccines can be effective. We have data that we can follow to try to improve the activity of those vaccines. We know a lot about the molecular biology of the parasite to target those vaccines, and we know increasingly more about how to apply those vaccines in the field. So I think there’s a great opportunity to make a difference in a relatively short amount of time, even though it will still take years. The progress is tangible so I think that’s exciting, and of course, malaria is an enormous medical problem that needs to be dealt with.
Read more »
Publications of interest
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An article describing the progress made in critical areas since the PATH Malaria Vaccine Initiative-sponsored 2010 transmission-blocking vaccine workshop was published in the journal Vaccine. It highlights key challenges that remain and outlines important next steps to maximize the potential for sexual, sporogonic, and/or mosquito-stage vaccines that interrupt malaria parasite transmission to contribute to the broader elimination and eradication objectives.
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An article in PLOS Medicine reports findings on safety and efficacy of the RTS,S/AS01 malaria vaccine candidate over an 18-month period following vaccination at 11 African sites across a wide range of malaria transmission settings.
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As part of the effort to inform local and national decision-making in preparation for possible malaria vaccine introduction, a recent qualitative study in Ghana’s Ashanti and Upper East Regions explored community-level factors that could affect vaccine acceptance. An article on the study, published in PLOS ONE, provides recommendations for a health communications strategy.
ASTMH roundup
Thanks to those of you who joined the ASTMH symposium “Accelerating the development of transmission-blocking vaccines for malaria elimination.”
The symposium covered topics that address the issues faced when developing a transmission-blocking vaccine (TBV) and helped explore potential pathways to regulatory approval. Speakers covered the experience of a vaccine developer testing a TBV candidate in a Phase 1 clinical trial as well as some of the challenges faced when a vaccine is tested in the field. A promising approach to generate the information required to assess the level of malaria transmission-blocking activity needed to lead to elimination under a given transmission setting (biting rate) was presented in a talk that uses murine models of transmission. Another speaker discussed the development of human challenge models that measure malaria transmission from human to mosquito, which may be useful for developing TBVs and accelerating approval. The final presentation covered the regulatory pathways for approval of TBVs.
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Pfs25-VLP-based transmission-blocking vaccine: Dr. Stephen Streatfield, Fraunhofer Center for Molecular Biotechnology
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Evaluating the impact of transmission-blocking vaccines in the field: Dr. Teun Bousema, London School of Hygiene and Tropical Medicine
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Assessment of anti-malarial transmission-blockade within laboratory populations: Dr. Andrew Blagborough, Imperial College London
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Investigating the Controlled Human Malaria Infection model as a platform to evaluate transmission-blocking interventions: Dr. James McCarthy, QIMR Berghofer Medical Research Institute
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Transmission blocking vaccines: Pathways to regulatory approval: Dr. Chris Ockenhouse, PATH Malaria Vaccine Initiative
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