US 11,052,143 B2
Vaccine for protection against ETEC-induced diarrhea comprising dmLT
Ann-Mari Svennerholm, Västra Frölunda (SE); Joshua Tobias, Gothenburg (SE); Nils Carlin, Bromma (SE); and Jan Holmgren, Västra Frölunda (SE)
Assigned to SCANDINAVIAN BIOPHARMA HOLDING AB, Solna (SE)
Filed by SCANDINAVIAN BIOPHARMA HOLDING AB, Solna (SE)
Filed on Jan. 27, 2020, as Appl. No. 16/773,713.
Application 16/773,713 is a continuation of application No. 14/744,874, filed on Jun. 19, 2015, granted, now 10,548,961, issued on Feb. 4, 2020.
Application 14/744,874 is a continuation of application No. 14/239,772, abandoned, previously published as PCT/EP2011/065784, filed on Sep. 12, 2011.
Prior Publication US 2020/0215173 A1, Jul. 9, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/108 (2006.01); A61K 45/00 (2006.01); A61K 47/00 (2006.01); A01N 63/00 (2020.01); A61K 48/00 (2006.01); A61K 9/00 (2006.01); A61K 39/00 (2006.01)
CPC A61K 39/0258 (2013.01) [A61K 9/0053 (2013.01); A61K 2039/521 (2013.01); A61K 2039/542 (2013.01); A61K 2039/55544 (2013.01); A61K 2039/70 (2013.01); Y02A 50/30 (2018.01)] 10 Claims
 
1. A vaccine, comprising 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) in an amount of 415-1245 μg per unit dose;
inactivated E. coli expressing Coli surface antigen 3 (CS3) in an amount of 1485-4455 μg per unit dose;
inactivated E. coli expressing Coli surface antigen 5 (CS5) in an amount of 255-765 μg per unit dose;
inactivated E. coli expressing Coli surface antigen 6 (CS6) in an amount of 60-180 μg per unit dose;
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,
wherein the vaccine comprises less than 1013 cells per unit dose and said vaccine is formulated for oral administration.