Phase I work has resulted in the successful development of a candidate P.falciparum malaria vaccine. The vaccine is composed of well- characterized neutralizing B cell epitopes and a universal human T cell epitope delivered on a highly immunogenic particulate carrier protein that effectively delivers 240 copies of each epitope on each particle. When formulated in alum, the vaccine candidate is a potent immunogen in mice eliciting unprecedented titers of sporozoite-neutralizing antibody. A universal CS-derived T cell epitope, incorporated into the vaccine candidate during phase I, facilitates a significant reduction in parasite load in the P.yoelii rodent system and effectively stimulates human T cells in vitro. The cell-mediated immunity afforded by the vaccine candidate should facilitate boosting of anti-sporozoite antibody titers in endemic regions, as well as the direct targeting of infected hepatocytes. The vaccine candidate has been produced in abundant quantities in E.coli using newly developed expression and purification methods that are fully scalable. Phase II work will focus on three areas: 1) completion of small animal studies of the vaccine candidate, 2) pre-clinical development of the vaccine candidate in preparation for human clinical trials, and 3) Phase I humans clinical trials.
Malaria is by far the world's most important tropical parasitic disease, and kills more people than any other communicable disease, with the exception of tuberculosis. Malaria is a public health problem in more than 90 countries, inhabited by a total of 2.4 billion people - 40% of the world's population. Mortality due to malaria is estimated to be in the range of 1.5 to 2.7 million deaths each year, accounting for one person every 12 seconds. There are 7 million travelers from the U.S. each year to endemic areas.
