# US 2021/0330775 A1 · Vaccine for protection against etec-induced diarrhea comprising dmlt

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- Number: US 2021/0330775 A1
- Document ID: US20210330775A1
- Status: Published application
- Kind: A1
- Application number: 17/305,236
- Filed: 2021-07-01
- Published: 2021-10-28
- Earliest claimed: 2014-04-23
- Assignees: Scandinavian Biopharma Holding AB, C/O Etvax AB
- Applicants: SCANDINAVIAN BIOPHARMA HOLDING AB, c/o Etvax AB
- Inventors: Ann-Mari SVENNERHOLM; Joshua TOBIAS; Nils CARLIN; Jan HOLMGREN
- Web page: https://patentgrep.com/patent/US20210330775A1

## CPC

- A61K 39/0258: {Escherichia}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 2039/521: {inactivated (killed)}
- A61K 2039/542: {oral/gastrointestinal}
- A61K 2039/55544: {Bacterial toxins}
- A61K 2039/70: {Multivalent vaccine}
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

An oral vaccine for immunization against ETEC-induced diarrhea, comprising inactivated Escherichia coli cells expressing an ETEC colonization factor antigen and dmLT protein adjuvant, wherein the vaccine preferably comprises less than 1013 cells per unit dose.

## Claims

### Claim 1

(canceled)

### Claim 2

A method of eliciting an immune response in a subject 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.

### Claim 3 (depends on 2)

The method according to claim 2, wherein the occasions are separated in time by 3-60 days.

### Claim 4 (depends on 3)

The method according to claim 3, wherein the occasions are separated in time by 5-21 days.

### Claim 5 (depends on 4)

The method according to claim 4, wherein the occasions are separated in time by 7-10 days.

### Claim 6 (depends on 2)

The method according to claim 2, wherein the vaccine is formulated in a solution to neutralize gastric acidity upon ingestion.

### Claim 7 (depends on 2)

The method according to claim 2, wherein the vaccine comprises per unit dose:
a) inactivated E. coli expressing CFA/I in an amount of 415-1245 Mg of CFA/I;
b) inactivated E. coli expressing CS3 in an amount of 1485-4455 μg of CS3;
c) inactivated E. coli expressing CS5 in an amount of 255-765 μg of CS5; and
d) inactivated E. coli expressing CS6 in an amount of 60-180 μg of CS6

### Claim 8 (depends on 2)

The method according to claim 2, wherein the vaccine comprises per unit dose LCTBA-protein in an amount of 500-1500 μg.

### Claim 9 (depends on 7)

The method according to claim 7, wherein the vaccine comprises per unit dose LCTBA-protein in an amount of 500-1500 μg.

### Claim 10

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.

### Claim 11 (depends on 10)

The method according to claim 10, wherein the occasions are separated in time by 3-60 days.

### Claim 12 (depends on 11)

The method according to claim 11, wherein the occasions are separated in time by 5-21 days.

### Claim 13 (depends on 12)

The method according to claim 12, wherein the occasions are separated in time by 7-10 days.

### Claim 14 (depends on 10)

The method according to claim 10, wherein the vaccine is formulated in a solution to neutralize gastric acidity upon ingestion.

### Claim 15 (depends on 10)

The method according to claim 10, wherein the vaccine comprises per unit dose:
a) inactivated E. coli expressing CFA/I in an amount of 415-1245 μg of CFA/I;
b) inactivated E. coli expressing CS3 in an amount of 1485-4455 μg of CS3;
c) inactivated E. coli expressing CS5 in an amount of 255-765 μg of CS5; and
d) inactivated E. coli expressing CS6 in an amount of 60-180 μg of CS6

### Claim 16 (depends on 10)

The method according to claim 10, wherein the vaccine comprises per unit dose LCTBA-protein in an amount of 500-1500 μg.

### Claim 17 (depends on 15)

The method according to claim 15, wherein the vaccine comprises per unit dose LCTBA-protein in an amount of 500-1500 μg.

### Claim 18

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);
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,
wherein the vaccine comprises less than 1013 cells per unit dose and said vaccine is formulated for oral administration.

### Claim 19 (depends on 18)

The vaccine according to claim 18, comprising per unit dose:
a) inactivated E. coli expressing CFA/I in an amount of 415-1245 μg of CFA/I;
b) inactivated E. coli expressing CS3 in an amount of 1485-4455 μg of CS3;
c) inactivated E. coli expressing CS5 in an amount of 255-765 μg of CS5; and
d) inactivated E. coli expressing CS6 in an amount of 60-180 μg of CS6

### Claim 20 (depends on 18)

The vaccine according to claim 18, wherein the vaccine comprises per unit dose LCTBA-protein in an amount of 500-1500 μg.

### Claim 21 (depends on 19)

The vaccine according to claim 19, wherein the vaccine comprises per unit dose LCTBA-protein in an amount of 500-1500 μg.