# US 11,439,700 B2 · Methods and compositions related to the next generation vaccine

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- Number: US 11,439,700 B2
- Document ID: US11439700B2
- Status: Granted
- Kind: B2
- Application number: 17/053,544
- Filed: 2019-05-03
- Published: 2021-08-19
- Granted: 2022-09-13
- Earliest claimed: 2018-05-06
- Assignees: University of Kansas
- Applicants: University of Kansas
- Inventors: Wendy L. Picking; William D. Picking
- Web page: https://patentgrep.com/patent/US11439700B2

## CPC

- C07K 14/25: Shigella (G)
- C07K 14/28: from Vibrionaceae (F)
- A61K 39/02: Bacterial antigens
- A61K 39/0291: {Yersinia}
- A61K 39/099: {Bordetella}
- A61K 39/104: {Pseudomonadales, e.g.} Pseudomonas
- A61K 39/107: {Vibrio}
- A61K 39/118: Chlamydiaceae, e.g. Chlamydia trachomatis or Chlamydia psittaci
- C07K 14/195: from bacteria
- C07K 14/21: from Pseudomonadaceae (F)
- C07K 14/235: from Bordetella (G)
- C07K 14/24: from Enterobacteriaceae (F), e.g. Citrobacter, Serratia, Proteus, Providencia, Morganella, Yersinia
- C07K 14/245: Escherichia (G)
- C07K 14/255: Salmonella (G)
- C07K 14/295: from Chlamydiales (O)
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C07K 2319/00: Fusion polypeptide
- C07K 2319/036: targeting to the medium outside of the cell, e.g. type III secretion
- 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
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- 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

Disclosed are methods and compositions related to polypeptides comprising a fusion of the needle tip protein and translocator protein of a type III secretion apparatus (T3SA) from a type III secretion system (T3SS) of a Gram negative bacteria. Disclosed herein are fusion polypeptides comprising a fusion of a needle tip protein, such as, Bsp22, LcrV, BipD, PcrV, CT053, or CT668, or anantigenic fragment thereof; and a translocator protein, such as, BopB, YopB, BipB, PopB, CopB, or CopB2, or anantigenic fragment thereof from a Type III secretion system (T3SS) of a Gram negative bacteria, such as, Bordetella, Burkholderia, Chlamydia, Pseudomonas, Vibrio, or Yersinia.

## Claims

### Claim 1

A fusion polypeptide comprising a fusion of a needle tip protein or an antigenic fragment thereof and a translocator protein or an antigenic fragment thereof from a Type III secretion system (T3SS) of Pseudomonas spp.; wherein the needle tip protein comprises PcrV as set forth in SEQ ID NO: 32 and the translocator protein comprises PopB as set forth in SEQ ID NO: 34; and wherein the fusion further comprises a double mutant labile toxin (dmLT) comprising the active moiety LTA1 or an antigenic fragment thereof from Enterotoxigenic Escherichia coli or cholera toxin or an antigenic fragment thereof.

### Claim 2 (depends on 1)

The polypeptide of claim 1, wherein the fusion polypeptide is arranged so that the needle tip protein is 5′ of the translocator protein.

### Claim 3 (depends on 1)

The polypeptide of claim 1, wherein the dmLT retains its ADP ribosylation activity.

### Claim 4 (depends on 1)

The polypeptide of claim 1, wherein the dmLT is 5′ of the needle tip protein and translocator protein fusion.

### Claim 5 (depends on 1)

A vaccine comprising the fusion polypeptide of claim 1.

### Claim 6 (depends on 5)

The vaccine of claim 5, further comprising one or more components of an acellular pertussis vaccine.

### Claim 7 (depends on 1)

A method of eliciting an immune response against Pseudomonas sp. in a subject in need thereof comprising administering to the subject a composition comprising the fusion polypeptide of claim 1 in an amount sufficient to elicit the immune response against said Pseudomonas sp.
