MVI Update: News from the PATH Malaria Vaccine Initiative

This issue: May 2012

Greetings from the director, Dr. Christian Loucq

Dear friends of the PATH Malaria Vaccine Initiative,

This fifth World Malaria Day was an opportunity for us to recognize the progress that the global malaria community has made against this disease, particularly in the last decade, and to take a strategic look at the work that remains to create a world free of malaria. The 655,000 lives lost and the millions who suffer every year should always be in the front of our minds as we research, develop, fund, partner, and work to use existing interventions and to build new tools for the fight against malaria.

At MVI, World Malaria Day 2012 was also a time to acknowledge the partners and donors who have made possible the progress toward a malaria vaccine. Thanks to their sustained support and hard work, the malaria vaccine effort has taken a significant step forward, with a first-generation vaccine candidate—GlaxoSmithKline’s RTS,S—in late-stage development. This vaccine candidate appears able to help protect young children in sub-Saharan Africa against severe malaria and clinical disease caused by the deadly Plasmodium falciparum malaria parasite. Thus, MVI’s priorities will include supporting RTS,S through the final stages of development. Eventually, if the vaccine candidate is approved and recommended for use, MVI would be ready to help ensure that it is delivered to the children in endemic countries who need it.

Even as RTS,S advances through the final stages of development, MVI is working with new and long-time partners across the globe—from countries in Europe and Africa to India and the United States—to identify and advance the development of next-generation vaccine approaches. Collaboration and data-driven decision-making are at the heart of MVI’s approach to accelerate the development of malaria vaccines and to ensure their availability and accessibility in the developing world.

Our portfolio now includes transmission-blocking vaccine approaches, one of which is in a clinical trial at Johns Hopkins University in collaboration with the US National Institutes of Health. These approaches seek to disrupt the lifecycle of the malaria parasite and interrupt transmission of the parasite by mosquitoes. We are continuing to weigh approaches against P. vivax, the malaria parasite that, though less deadly than P. falciparum, sickens many more people in many more places.

Our work goes beyond the science of vaccine research and development as we work to answer key questions: how, when, and where might a malaria vaccine best be used? How can it best complement existing and new interventions? How will communities and individuals value a malaria vaccine? Do developing countries have the data they need to make the best-informed decisions and the infrastructure to effectively deliver a new vaccine? Who will pay for a malaria vaccine destined solely for low-income public markets and how? How much more investment will be needed in 5, 10, 20 years? Answers to these and other questions are critical to guiding our investments and our research strategy.

We look forward to continued productive collaborations throughout the remainder of 2012, including the availability of the next set of RTS,S Phase 3 results sometime this fall.

On a personal note, I am honored and thrilled to lead the team at MVI and to join with our many partners in the shared goals of first creating and then sustaining a world free of malaria.

Sincerely,
David C. Kaslow, MD

 

Vaccine Formulation Center opens in Pune, India

Image

A center devoted to selecting and developing stable and efficacious formulations for vaccines against malaria and other pathogens has opened in Pune, India.

The new Vaccine Formulation Center is the result of a collaboration among MVI, the Pune-based biopharmaceutical company Gennova, and the Seattle-based Infectious Disease Research Institute.

The center’s primary goal is to research, develop, and manufacture—by current Good Manufacturing Practices—adjuvant formulations for malaria vaccines as well as for vaccines against other pathogens, such as Leishmania.

Read more »

Trial of RTS,S in HIV-positive infants and young children reaches full enrollment

Among the many questions the Phase 3 trials of RTS,S are designed to answer is whether the vaccine candidate will be safe and immunogenic in HIV-positive children, given the incidence of mother-to-child HIV transmission in parts of Africa. There are many challenges in such a trial, since infected infants can rapidly become too ill to participate in a clinical trial. Full enrollment in the trial was reached at the end of March, with 200 participants aged 6 weeks to 17 months, paving the way for the availability of data in late 2014.

Progress continues to support informed decision-making

If a malaria vaccine is recommended for use, then country readiness for decision-making will be necessary for rapid and optimal uptake. MVI supports a wide range of activities designed to help ensure that countries have the data and mechanisms to make informed decisions regarding vaccine adoption and use, and to do so without incurring undue delays in vaccine uptake. Key efforts in the first quarter of 2012 included a stakeholder meeting in Maputo to share findings from a study on community perceptions of malaria and vaccines in Mozambique and meetings of consultative groups on malaria vaccines in Ghana, Rwanda, Senegal, and Tanzania.

Malaria Vaccine Advocacy Fellowship set for June 2012

A program designed to strengthen the capacity of malaria scientists and clinicians in Africa to bridge between and among the worlds of science, policy, and the interested public will be conducted this year in Ghana. The program, the Malaria Vaccine Advocacy Fellowship, is a collaborative effort between MVI and Burness Communications. Supported by the ExxonMobil Foundation, this year’s program is planned for June 19–22 in Accra.

Read more »

Final OPTIMALVAC meeting held in Paris

MVI participated in the final meeting of the three-year European Commission-funded OPTIMALVAC project on assay harmonization, held March 21–22 in Paris. Participating teams reported on progress toward harmonizing the merozoite immunofluorescence assay, the antibody-dependent cellular inhibition assay, IFN-gamma ELISpot, and the intracellular cytokine staining assay, as well as development of tools such as templates for reporting data, software for analyzing data, and websites for reporting data and standard operating procedures. MVI has supported this project by supplying reagents used in the harmonization exercises and funding the UK National Institute for Biological Standards and Control to provide central coordination support.

World Malaria Day 2012

Image

The theme for World Malaria Day 2012—Sustain Gains, Save Lives: Invest in Malaria—marked an important point in the fight against the disease. Whether the malaria map will keep shrinking, and research and development (R&D) for new, more effective tools will continue, depends to a great extent on the resources that will be invested over the coming years. To highlight the need for continued funding of malaria R&D, MVI sponsored a number of events around April 25.

Future Directions in Malaria: Accelerating Progress

On April 19, PATH held an event to highlight its malaria programs in advance of World Malaria Day with panelists Dr. David Kaslow, Director of the Malaria Vaccine Initiative, Dr. Rick Steketee, Scientific Director of the Malaria Control and Evaluation Partnership in Africa, and Hugh Chang, interim CEO of OneWorld Health, a nonprofit drug development company that has recently become an affiliate of PATH. The panel discussion was moderated by Dr. Carter Diggs, Senior Technical Advisor for the US Agency for International Development.

The panelists discussed the integral role the US government has played in the fight against malaria. They noted the importance of continued funding to sustain gains made through malaria control efforts, and for the development of more effective tools, like new drugs and vaccines, that could get us closer to the ultimate goal of eradication.

“I think many people in and outside of the endeavor are worried now about the future in the sense that, if you relax your vigilance, that’s exactly when the parasite will bite back with a vengeance,” noted Dr. Diggs. “We need to try to be smarter than the parasite. We need to learn the parasite’s tricks and circumvent them.”

Find out more about this event and view a recording of the event »

Advancements in US Science and Technology in Malaria: A Showcase of Domestic Research & Development to Save Lives and Keep Americans Safe

On April 25, PATH co-sponsored an event on Capitol Hill to commemorate World Malaria Day. The event was attended by researchers, academics, nongovernmental organization partners, and government officials, and sponsored by Malaria No More, PATH, and a number of other organizations working to combat malaria. During the first half of the event, top malaria researchers and innovators from US biotechnology companies and research institutions highlighted their contributions to and ongoing research in the fight against malaria. 

Each of the researchers highlighted compelling reasons why the US government and other donors should continue to fund malaria research and development (R&D), including job creation in the growing biotechnology sector, the threat that malaria poses to the US military abroad, and most importantly, the fact that people continue to suffer and die from a disease that is preventable. Dr. Dyann Wirth of Harvard University and Dr. Lee Hall of the US National Institute of Allergy and Infectious Diseases drove home the point that while we have made great progress in the fight against this disease, we cannot let down our guard. R&D for new technologies and continued funding are critical to ensuring we do not lose the gains made.

A Congressional reception followed the event, and featured speakers from both political parties voiced their commitment to eradicating malaria. Dr. Rajiv Shah, Administrator of the US Agency for International Development (USAID), emphasized USAID’s continued commitment to combating malaria, and Representative Jim McDermott (D-WA) closed the event by acknowledging PATH and RTS,S. “I’m very proud that the development of RTS,S is happening through organizations in my district—PATH and the Bill & Melinda Gates Foundation,” he said. “If we can vaccinate and get rid of malaria, we have done a world of difference.”

World Malaria Day European Union Parliament Working Lunch & Reception

In Brussels, MVI collaborated with the Roll Back Malaria (RBM) Partnership, the International Federation of the Red Cross (IFRC), the Norwegian Red Cross, the Red Cross European Union (EU) Office, the Malaria Consortium, Malaria No More UK, the European Parliamentary Working Group on Innovation and Access to Medicines, and the African, Caribbean, and Pacific Countries (ACP) Secretariat to host a working lunch in the European Parliament, followed by a reception at the ACP Secretariat, to mark World Malaria Day.

The working lunch focused on next steps to support the 2011 Oslo Accord, which laid out strategies in the fight against malaria, and on the need for new tools for research and development (R&D). Dr. Tsiri Agbenyega, Chair of the RTS,S Clinical Trials Partnership Committee and Principal Investigator for the Agogo, Ghana, trial site, addressed the importance of continued EU investment in malaria R&D and used RTS,S as a key example of a successful large-scale, north-south, public-private collaboration. Other speakers included representatives from the World Health Organization, RBM Partnership, IFRC, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the European Commission (EC).

At the reception, speakers from the EC, ACP Secretariat, and IFRC urged ACP country ambassadors to keep up the pressure on their governments to include malaria funding in their country requests to the European Development Fund, and the EC committed to continue funding for malaria R&D and implementation. Both events were designed to help inform key stakeholders in the policymaking process as the European Parliament continues to develop the EC budget for the period 2014 through 2020.

World Malaria Day links

Keep in touch!

Interested in staying abreast of the latest developments in the malaria vaccine and global health fields?

Forward this newsletter to a friend
Click here to unsubscribe

PATH Malaria Vaccine Initiative
455 Massachusetts Avenue NW, Suite 1000
Washington, DC, USA 20001
Tel: 202.822.0033 | Fax: 202.457.1466
mvi_info@path.org
www.malariavaccine.org