Patent ID: 11918636
Assignee: SCANDINAVIAN BIOPHARMA HOLDING AB, C/O ETVAX AB
Field: Pharmaceuticals (Chemistry)
Classification: CPC A  Y | IPC A

Claim 6:
7. A method of immunizing a subject against enterotoxigenic E. coli (ETEC)-induced diarrhea, comprising orally administering a unit dose of a vaccine to the subject on at least two separate occasions separated in time by at least 3 days, wherein the vaccine comprises:
inactivated Escherichia coli (E. coli) cells expressing enterotoxigenic E. coli (ETEC) colonization factor antigens comprising:
inactivated E. coli expressing colonization factor A/I (CFA/I);
inactivated E. coli expressing Coli surface antigen 3 (CS3);
inactivated E. coli expressing Coli surface antigen 5 (CS5);
inactivated E. coli expressing Coli surface antigen 6 (CS6);

a hybrid protein comprising a B-subunit of E. coli heat-labile enterotoxin (LTB) and a B-subunit of cholera toxin (CTB) (LCTBA-protein); and
a double mutant heat-labile toxin (dmLT) protein at 8-30 μg per unit dose, and
wherein the vaccine comprises less than 1013 cells per unit dose and said vaccine is formulated for oral administration, and wherein th vaccine is formulated in a solution to neutralize gastric acidity upon ingestion.