Malaria causes an estimated 500 million clinical cases and up to 2.7 million deaths annually, is responsible for a loss of greater than 1% of GDP in Africa annually, and is a serious concern for travelers and military personnel. Sanaria's goal is to develop and commercialize a > 90% protective attenuated Plasmodium falciparum (Pf) sporozoite vaccine for 2 primary markets with a potential for > $1 billion annual revenues; 1) Travelers from the developed world and 2) Infants and young children in the developing world. In limited trials, this type of immunization has protected > 90% of human volunteers against experimental Pf challenge, protect for > 10 months after last immunization, and protect against heterologous parasite challenge. No other experimental malaria vaccine under development has been shown to approach these performance characteristics. Heretofore it has been considered impractical to develop such a vaccine, because it was not considered feasible to, 1) Immunize humans by a clinically acceptable parenteral route, 2) Produce adequate quantities of sporozoites, and 3) Practically produce the aseptic, homogenously purified and characterized, radiation attenuated, stable, cryopreserved sporozoites needed to meet regulatory and commercial standards for a vaccine. Phase I funding for this project supported the successful demonstration in the P. yoelii (Py) rodent model system that it was feasible to produce, characterize and administer by a clinically acceptable route a purified, cryopreserved radiation attenuated malaria sporozoite vaccine. Using Phase I and other funding Sanaria has generated data indicating that all of the potential feasibility questions are not obstacles, and further work is solidifying these findings. The Phase II project is to, 1) Complete process development and generation of a technology transfer package, including standard operating procedures for clinical manufacture and characterization of the vaccine, 2) Manufacture and characterize the first engineering run (lot) of the vaccine, 3) Manufacture the vaccine under cGMP conditions. 4) Conduct all studies required for Investigational New Drug Application (IND) submission to the FDA, and 5) Write and submit the IND. A phase III follow up project will assess the safety, immunogenicity and protective efficacy of the vaccine in experimentally challenged volunteers (Phase I/I la clinical trial) in Maryland and in naturally exposed adults (Phase I/lib) in Ghana. Success in these first clinical trials will lead to a massive development effort leading to licensure and deployment of the vaccine.
