Drug intelligence / Profile preview

ETVAX

Development stage
Phase 2
Lead developer
Scandinavian Biopharma
Modality
Vaccines & Immunotherapeutics
Administration
Oral
01

Overview

**ETVAX** is an investigational oral, inactivated whole-cell vaccine designed to prevent diarrhoeal disease caused by enterotoxigenic *Escherichia coli*. It contains four inactivated recombinant *E. coli* strains that overexpress the colonization factors CFA/I, CS3, CS5, and CS6, plus the recombinant hybrid B-subunit toxoid antigen LCTBA; clinical formulations have also used double-mutant heat-labile toxin as a mucosal adjuvant. The vaccine is intended to induce mucosal and systemic immunity that blocks ETEC intestinal colonization and counteracts heat-labile enterotoxin-mediated disease. Scandinavian Biopharma is advancing ETVAX for young children in endemic settings and for prevention of ETEC-associated travellers' diarrhoea; Phase 2b efficacy studies have been completed, and the sponsor has stated that the programme is ready to advance into pivotal Phase 3 development. ([cdn.clinicaltrials.gov](https://cdn.clinicaltrials.gov/large-docs/34/NCT05178134/Prot_SAP_000.pdf))

Brand names
ETVAX
Other names
ETEC vaccineoral inactivated enterotoxigenic Escherichia coli vaccinetetravalent ETEC vaccine
02

Targets

LTB (Heat-labile enterotoxin B subunit)CS5 (Colonization factor antigen 5)CS3 (Coli surface antigen 3)CFA/I (Colonization factor antigen I)CS6 (Colonization factor antigen 6)

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