The clinical study will contain two study arms. The first study arm will include three antigens, two pre-erythrocytic (CSP and TRAP) and one blood stage (AMA-1), shown previously to protect against Plasmodium falciparum, the most deadly malaria strain. The second study arm will include two additional pre-erythrocytic-stage antigens (LSA-1 and CelTOS).
Dr. J. Joseph Kim, President and CEO of Inovio, said, "We are pleased to work with MVI to advance into a human study with Inovio's plasmid DNA. Our synthetic vaccine platform has produced vaccine candidates against HPV, HIV, and influenza targets that have generated potent T cell immune responses observed in human clinical studies. Using the same platform technology, we have now generated encouraging data with preclinical testing of our malaria antigen plasmids. We are excited to work with our collaborators at MVI toward the ultimate goal of conquering malaria."
The focus on vaccines that deliver multiple antigens simultaneously is a leading approach to developing highly effective malaria vaccines. The Inovio platform is technically well suited to deliver multiple target antigens and has effectively demonstrated in preclinical studies an ability to induce potent immune responses to these antigens. This is one of a series of platforms MVI plans to evaluate for its capacity to induce immune responses that confer protection from malaria infection in the human challenge model.
The Phase 1/2a clinical trial, which will begin in early 2014, will test Inovio's plasmid DNA and electroporation technology in approximately 30 individuals, as part of what is known as a challenge trial by controlled human malaria infec
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