GeMI-Vax as a multi-life stage malaria vaccine

Malaria caused by Plasmodium falciparum results in serious illness and, if untreated, often leads to death. Although a number of candidate vaccines have progressed to clinical trials the efficacy rate of those vaccines was much lower than ideal. New methods for simultaneous presentation and immune stimulation of malarial antigens are needed in order to rapidly progress promising antigens into efficacious vaccines. Platforms that present antigen to the immune system in a particulate manner that mimics the structure of a natural pathogen may improve the effectiveness of a vaccine. Prior work has demonstrated that Vital Probes, Gene-Mediated Inactivated Vaccine (GeMI-Vax) platform in E. coli combined with malaria antigens results in a protective immune response in mouse models of malaria. The GeMI-Vax production method gently inactivates bacteria that are engineered to express malaria protein antigens. The resulting particle-based vaccine has inherent adjuvant activity and appropriately presents vaccine antigens and stimulates the immune system. Phase I SBIR work resulted in successful expression of malaria antigens in E. coli and Shigella. In Phase II, Shigella-GeMI-Vax expressing malaria antigens will be produced and tested in animal efficacy models. Demonstration of efficacy will lead to follow-on research and development efforts towards testing in human clinical trials.