Award from Federal Ministry of Education and Research to support effort to further optimize efficacy of RTS,S
Seattle, December 1, 2016—PATH welcomed the announcement this week of a five-year, €7.8 million grant from Germany's Federal Ministry of Education and Research (BMBF) to support testing of a promising alternate regimen of RTS,S, the malaria vaccine candidate most advanced in development globally. The funds, granted to PATH's Malaria Vaccine Initiative, will support a Phase 2b clinical trial at two sites in sub-Saharan Africa. The trial is expected to enroll approximately 1,500 children 5 to 17 months of age, starting in late 2017.
"While we have recently received government support from other countries in Europe, as well as Japan and the United States, for research and development, this is the first time PATH has received funds for product development from the German government," said David C. Kaslow, MD, vice president for essential medicines and head of PATH's Center for Vaccine Innovation and Access. "Public sector support for product development partnerships to meet the health needs of those in the lowest-resource settings is vital to achieving our mission and we thank BMBF for their vote of confidence."
The German grant is the first from a European government for malaria vaccine development at PATH, which has partnered with GSK in the development of RTS,S since 2001. The field trial being supported by BMBF will test whether results of a small-scale study of adults in the United States can be replicated in children living in a malaria-endemic setting. The earlier US trial demonstrated that a delayed and reduced third dose of RTS,S was associated with 87 percent vaccine efficacy. While the effect declined to 40 percent after seven months, a fractional fourth dose boosted the efficacy back up to 90 percent.
"If the US results are borne out in settings where natural malaria infections occur, this vaccine regimen could dramatically reduce malaria infections and disease and eventually help to accelerate elimination of the malaria parasite altogether," said Ashley Birkett, PhD, director of PATH's Malaria Vaccine Initiative. "Malaria eradication is the ultimate goal, and a vaccine that is proven effective in a wide range of populations could be a powerful tool added to existing interventions like bednets, drugs, and insecticides. This forthcoming trial is an important step in that process."
According to the World Health Organization, there were an estimated 214 million malaria cases and 438,000 malaria deaths worldwide in 2015. The vast majority of illnesses and deaths occurred in sub-Saharan Africa, and most were in children under the age of five.
First conceived in the 1980s, the RTS,S candidate malaria vaccine has undergone a series of studies, including a Phase 3 clinical trial of the current, four-dose regimen that involved over 15,000 infants and young children and 11 sites in seven African countries. The Phase 3 clinical trials concluded in early 2014. Since then, the candidate vaccine's data have been reviewed by two leading health authorities. First, RTS,S received a positive scientific opinion from Europe's regulatory health authority, the European Medicines Agency, in July 2015. Then, after a consultation process, WHO recommended taking this candidate vaccine forward into pilot implementation.
RTS,S is designed to help prevent Plasmodium falciparum malaria in sub-Saharan Africa, and is proposed as a complement to other malaria control interventions, such as bednets, and appropriate case management. Pilot implementation of the current RTS,S regimen is expected to start in three African countries in 2018.
The Phase 2b clinical trial of the alternate dosing regimen is targeted to start in late 2017. The €7.78 million in new funds from BMBF, administered by the German Development Bank KfW, will be added to support for the Phase 2b trial provided by product development partners GSK and PATH, the latter with funds from the Bill & Melinda Gates Foundation for development of next-generation malaria vaccines.
PATH's MALARIA VACCINE INITIATIVE (MVI) accelerates malaria vaccine development and catalyzes timely access in endemic countries, toward a world free from malaria. Standing at the intersection of malaria and immunization, MVI is part of PATH's Center for Malaria Control and Elimination and PATH's Center for Vaccine Innovation and Access. Learn more www.malariavaccine.org or http://sites.path.org/cvia.