Research and Innovation

USAID’s engagement and support for research and development on the prevention and treatment of malaria is longstanding and has yielded solid results. This includes providing support for the initial studies that demonstrated the effectiveness of insecticide-treated mosquito nets, which ultimately resulted in this tool becoming a core malaria control intervention. Drug efficacy monitoring conducted with USAID support provided key evidence documenting the emergence of artemisinin resistance on the Thai-Cambodia border in the late 2000s. Several new artemisinin-based combination therapies and treatments for severe malaria were developed with USAID’s support, and the Agency has worked to lift the regulatory hurdles to allow the introduction of these much-needed new treatments into countries. USAID’s current priorities for research and development are three-pronged and include the development of malaria vaccines, novel insecticide-based vector control tools, and new antimalarial drugs. Key activities in these areas include:

Malaria Vaccine Development Program (MVDP)

USAID has been a driving force for innovation in malaria vaccine development for more than five decades, evolving from initially supporting basic research in academic settings to now supporting a broad range of activities from preclinical testing to conducting clinical trials. In the 1970s, USAID supported the discovery of methods for the culture of the malaria parasite, an achievement that was arguably the most important advance in malaria research in the twentieth century. This advance accelerated malaria drug and vaccine development and contributed to other areas of research. Subsequently, USAID supported seminal work on a key component of the parasite (the circumsporozoite protein) that enabled the first clinical trial of a peptide-based malaria vaccine and led to the development of the RTS,S vaccine.

The MVDP continues to be a major funder and supporter of malaria vaccine development efforts across the globe. It has forged alliances and leveraged its funds with major research groups that have been leading dedicated malaria vaccine programs, which include the Walter Reed Army Institute of Research (WRAIR), the Naval Medical Research Center (NMRC), the National Institute of Allergy and Infectious Diseases (NIAID), and the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative (MVI). With WRAIR, USAID supported development and evaluation of blood stage vaccines that were subsequently tested in the field with MVI in Kenya and with NIAID in Mali. USAID has also supported the development of preerythrocytic vaccines at WRAIR and NMRC, including demonstrating in a series of clinical trials with NMRC the potential of this approach to destroy parasites in the liver, thus preventing invasion of the blood with accompanying clinical disease. A confirmatory clinical trial on the preerythrocytic approach with NMRC will be initiated in 2017. Currently, USAID supports WRAIR’s development of a vaccine that may improve upon RTS,S, with a first in-human trial planned in 2018. The USAID MVDP is currently exploring the potential of new vaccine designs to further accelerate progress toward highly efficacious, durable, and affordable vaccines against this major killer of children in the developing world.

Innovative Vector Control Consortium (IVCC)

The Innovative Vector Control Consortium (IVCC) is a not-for-profit public-private partnership whose mission is to save lives, protect health, and increase prosperity in areas where diseases transmitted by insects are endemic. IVCC targets practical scientific solutions to accelerate the process from innovation to impact, such as developing new insecticides.

USAID provides financial support to support IVCC’s vector control development work. For example, USAID supports two large portfolios of new insecticide development with Bayer and Syngenta; lead and back-up vector control compounds have been selected and evaluated for development studies and optimization. The aim is for these novel compounds, which are not currently used in public health or agriculture, to begin to be evaluated by the World Health Organization for malaria vector control by 2025.

Medicines for Malaria Venture (MMV)

The Medicines for Malaria Venture (MMV) is a product development partnership in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing, and delivering new, effective, and affordable antimalarial drugs. In partnership with MMV, USAID support helped to move Coartem Dispersible – the first child-friendly artemisinin-based combination therapy for malaria – from product development to the scale-up stage. This important pediatric drug has since been introduced to 50 malaria-endemic countries worldwide, with more than 300 million pediatric treatments distributed. Support from USAID has also contributed to the development of two novel antimalarial agents that are effective against drug-resistant strains of the parasite and may be promising alternatives to artemisinin-based formulations. These are now being tested in combination with partner drugs in Phase II trials.

Innovation

Innovations are critical to help the international development community achieve goals in the fight against malaria and other global health challenges. USAID streamlines processes, participates in market shaping initiatives, and works collaboratively with other partners. For example, as a leading procurer of malaria products, PMI actively engages with the global malaria marketplace to ensure access to quality malaria prevention, diagnosis, and treatment products at affordable prices. Through strategic sourcing and market analysis, PMI contributed to the reduction in the price of critical malaria products. The price of ITNs has declined almost 50 percent from $5.46 in 2007 to $2.45 in 2016. Similarly, the global price of the most commonly used malaria rapid diagnostic test has decreased 34 percent from 2013 to 2016. In addition, PMI, in collaboration with the USAID Global Health Bureau’s Center for Innovation and Impact (CII), identifies market-shaping opportunities to maximize market forces and accelerate access to lifesaving innovations. PMI, CII, and other partners are engaged with UNITAID and IVCC’s Next Generation Indoor Residual Spray Project to stimulate development of and facilitate access to new insecticides for malaria control. This project uses a co-payment program to lower the cost of novel, long-lasting residual sprays while strengthening demand forecasting and fostering competition to keep prices affordable over the long term. Furthermore, PMI collaborates with the Bill & Melinda Gates Foundation’s (BMGF) Global Health Infectious Diseases team in a number of areas, providing input on programmatic and strategic priorities and activities in malaria with the long-term goal of eradication. PMI and BMGF coordinate support, for example, in the Greater Mekong Subregion, where the emergence of ACT resistance threatens the region’s impressive progress in malaria control.