# US 10,500,262 B2 · Synthetic antigen constructs against Campylobacter jejuni

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- Number: US 10,500,262 B2
- Document ID: US10500262B2
- Status: Granted
- Kind: B2
- Application number: 15/891,426
- Filed: 2018-02-08
- Published: 2018-06-28
- Granted: 2019-12-10
- Earliest claimed: 2014-11-05
- Assignees: The United States of America as represented by the Secretary of the Navy
- Applicants: United States of America as Represented by the Secretary of the Navy
- Inventors: Patricia Guerry; Mario Artur Monteiro; Yuening Jiao
- Web page: https://patentgrep.com/patent/US10500262B2

## CPC

- A61K 39/105: {Delta proteobacteriales, e.g. Lawsonia; Epsilon proteobacteriales, e.g. campylobacter, helicobacter}
- A61P 1/12: Antidiarrhoeals
- A61P 31/04: Antibacterial agents
- A61P 37/02: Immunomodulators
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07H 11/04: Phosphates; Phosphites; Polyphosphates
- C07H 13/00: Compounds containing saccharide radicals esterified by carbonic acid or derivatives thereof, or by organic acids, e.g. phosphonic acids
- A61K 2039/6037: {Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]}
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07H: SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS (derivatives of aldonic or saccharic acids C07C, C07D; aldonic acids, saccharic acids C07C59/105, C07C59/285; cyanohydrins C07C255/16; glycals C07D; compounds of unknown constitution C07G; polysaccharides, derivatives thereof C08B; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification C12N15/00; sugar industry C13)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The invention relates to immunogenic synthetic constructs capable of inducing an immune response against Campylobacter jejuni (C. jejuni) in a subject comprising one or more monosaccharides comprising one or more MeOPN moieties. Specifically, the invention relates to immunogenic synthetic constructs capable of inducing an immune response against Campylobacter jejuni (C. jejuni) in a subject comprising one or more MeOPN→6 Gal monosaccharides. The invention also relates to compositions comprising the immunogenic synthetic constructs and methods of inducing an immune response against C. jejuni in a subject comprising administering the immunogenic synthetic constructs, and/or compositions comprising the immunogenic synthetic construct, to the subject.

## Claims

### Claim 1

An immunogenic synthetic construct capable of inducing an immune response against Campylobacter jejuni (C. jejuni) in a subject, wherein said immunogenic synthetic construct comprises one or more MeOPN-6-Gal monosaccharides and one or more MeOPN-2-Gal monosaccharides.

### Claim 2 (depends on 1)

The immunogenic synthetic construct of claim 1 wherein the immunogenic synthetic construct is conjugated to a carrier protein.

### Claim 3 (depends on 2)

The immunogenic synthetic construct of claim 2 wherein the carrier protein contains at least one T-cell epitope.

### Claim 4 (depends on 2)

The immunogenic synthetic construct of claim 2 wherein the carrier protein is an ETEC protein or CRM197.

### Claim 5 (depends on 1)

The immunogenic synthetic construct of claim 1 further comprising one or more additional saccharides.

### Claim 6 (depends on 5)

The immunogenic synthetic construct of claim 5 wherein the one or more additional saccharides is selected from the group consisting of monosaccharides containing one or more MeOPN moieties, galactose, fructose, glucose, heptose, N-acetyl galactosamine, N-acetyl glucosamine, glucitol, glucose, and modified forms of derivatives thereof.

### Claim 7 (depends on 6)

The immunogenic synthetic construct of claim 6 wherein said monosaccharide containing one or more MeOPN moieties is MeOPN-1-Fru.

### Claim 8 (depends on 5)

The immunogenic synthetic construct of claim 5 wherein said one or more additional saccharides is selected from the group consisting of CPS repeating blocks, heptose units, and MeOPN linkages of C. jejuni serotype complexes HS1, HS3, HS4, and HS23/36.

### Claim 9 (depends on 8)

The immunogenic synthetic construct of claim 8 wherein said MeOPN linkages of C. jejuni serotype complexes HS1, HS3, HS4, and HS23/36 are selected from the group consisting of
of HS 1;
of HS4;
of HS23/36.

### Claim 10 (depends on 1)

A composition comprising the immunogenic synthetic construct of claim 1.

### Claim 11 (depends on 10)

The composition of claim 10 wherein said composition is a pharmaceutical composition.

### Claim 12 (depends on 11)

The composition of claim 11 wherein said pharmaceutical composition is a vaccine.

### Claim 13 (depends on 12)

The composition of claim 12 wherein said vaccine is a monovalent vaccine or a polyvalent vaccine.

### Claim 14 (depends on 13)

The composition of claim 13 wherein said polyvalent vaccine comprises a formulation against one or more strains of C. jejuni.

### Claim 15 (depends on 14)

The composition of claim 14 wherein said polyvalent vaccine further comprises a formulation against enterotoxigenic Escherichia coli (ETEC) or Shigella.

### Claim 16 (depends on 14)

The composition of claim 14 wherein said one or more strains of C. jejuni is selected from the group consisting of C. jejuni serotypes HS 23/36, HS 1, HS2, HS3, HS4, and HS5/31.

### Claim 17 (depends on 12)

The composition of claim 12 wherein said vaccine further comprises an additional immunoregulatory agent.

### Claim 18 (depends on 17)

The composition of claim 17 wherein the additional immunoregulatory agent is selected from the group consisting of antigens of one or more strains of C. jejuni, antigens of enterotoxigenic Escherichia coli (ETEC), Shigella lipopolysaccharide structures, and unconjugated carrier proteins.

### Claim 19 (depends on 12)

The composition of claim 12 wherein said vaccine further comprises one or more adjuvants.

### Claim 20 (depends on 19)

The composition of claim 19 wherein said adjuvant is selected from the group consisting of toll-like receptor ligands, aluminum phosphate, aluminum hydroxide, monophosphoryl lipid A, liposomes, saponins, QS-21, and derivatives and combinations thereof.

### Claim 21 (depends on 1)

A method of inducing an immune response against C. jejuni in a subject comprising administering to the subject an effective amount of the immunogenic synthetic construct of claim 1.

### Claim 22 (depends on 21)

The method of claim 21 wherein the subject is human.

### Claim 23 (depends on 11)

A method of inducing an immune response against C. jejuni in a subject comprising administering to the subject an effective amount of the composition of claim 11.

### Claim 24 (depends on 23)

The method of claim 23 wherein the subject is human.

### Claim 25 (depends on 12)

A method of inducing an immune response against C. jejuni in a subject comprising administering to the subject an effective amount of the composition of claim 12.

### Claim 26 (depends on 25)

The method of claim 25 wherein said subject is a human.

### Claim 27 (depends on 20)

A method of inducing an immune response against C. jejuni in a subject comprising administering to the subject an effective amount of the composition of claim 20.

### Claim 28 (depends on 27)

The method of claim 27 wherein said subject is a human.

### Claim 29 (depends on 1)

A method of inducing an immune response against C. jejuni in a subject, said method comprising
(a.) administering to the subject an effective amount of the immunogenic synthetic construct of claim 1; and
(b.) optionally administering to the subject one or more boosting doses of the immunogenic synthetic construct administered in step (a).

### Claim 30 (depends on 29)

The method of claim 29 wherein the effective amount administered in step (a) is from about 0.1 μg to about 10 mg of the immunogenic synthetic construct.

### Claim 31 (depends on 29)

The method of claim 29 wherein said method further comprises administering an adjuvant with the construct in step (a) and/or step (b).

### Claim 32 (depends on 31)

The method of claim 31 wherein the adjuvant is selected from the group consisting of toll-like receptor ligands, aluminum phosphate, aluminum hydroxide, monophosphoryl lipid A, liposomes, saponins, QS-21, and derivatives and combinations thereof.

### Claim 33 (depends on 12)

A method of inducing an immune response against C. jejuni in a subject, said method comprising
(a). administering to the subject an effective amount of the composition of claim 12; and
(b). optionally administering to the subject one or more boosting doses of the composition administered in step (a).

### Claim 34 (depends on 33)

The method of claim 33 wherein the effective amount administered in step (a) is from about 0.1 μg to about 10 mg of immunogenic synthetic construct.

### Claim 35 (depends on 34)

The method of claim 34 wherein said method further comprises administering an adjuvant with the construct in step (a) and/or step (b).

### Claim 36 (depends on 35)

The method of claim 35 wherein the adjuvant is selected from the group consisting of toll-like receptor ligands, aluminum phosphate, aluminum hydroxide, monophosphoryl lipid A, liposomes, saponins, QS-21, and derivatives and combinations thereof.