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The oral tetravalent ETEC vaccine (ETVAX) is an oral, inactivated whole-cell vaccine developed by Scandinavian Biopharma in collaboration with the University of Gothenburg and PATH. It is designed to prevent diarrheal disease caused by enterotoxigenic Escherichia coli (ETEC) in both infants in low- and middle-income countries (LMICs) and travelers. The vaccine consists of four inactivated recombinant E. coli strains that overexpress the major ETEC colonization factor (CF) antigens CFA/I, CS3, CS5, and CS6, combined with LCTBA, a recombinant hybrid protein of the heat-labile enterotoxin B subunit (LTB) and cholera toxin B subunit (CTB). ETVAX is administered orally with a bicarbonate buffer and can be co-administered with the double-mutant heat-labile toxin (dmLT) as a mucosal adjuvant to enhance mucosal and systemic immune responses. It has completed Phase 2b clinical trials with promising safety, immunogenicity, and protective efficacy, and is currently preparing for pivotal Phase 3 clinical evaluation.
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