SBIR-STTR Award

Malaria is a disease which affects more than 300 million people each year and is fatal for 1.5 million. The overall objective of this STTR Phase I project is to produce a cGMP malaria vaccine consisting of the 42 kDa C-terminal polypeptide of P. falciparum merozoite surface protein-1 (MSP1.42) to be formulated with QS21 adjuvant for preclinical studies and a future clinical Phase I trial. Evidence is presented that MSP1.42/QS-21 protects against P. falciparum malaria in the Aotus monkey model. Data is also presented supporting the feasibility of large-scale MSP1.42 production in the baculovirus system and its purification by standard chromatography. The goals of the project are (1) production of master cell banks of insect cell lines for virus stock and polypeptide production, respectively; (2) preparation of a virus stock of recombinant MSP1.42 baculovirus; (3) production of bulk MSP1.42 antigen in a bioreactor; (4) purification of MSP1.42; (5) establishment of analytical methods to define product specifications; and (6) evaluation of the immunogenicity of the cGMP MSP1.42/QS21 formulation in mice and Aotus and of its efficacy in Aotus. These studies will provide cGMP material and preclinical information for a clinical trial of MSP1.42/QS21 during STTR Phase II