# US 12,005,106 B2 · Gut bacteria derived microvesicles for vaccine delivery

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- Number: US 12,005,106 B2
- Document ID: US12005106B2
- Status: Granted
- Kind: B2
- Application number: 17/309,067
- Filed: 2019-10-22
- Published: 2022-04-07
- Granted: 2024-06-11
- Earliest claimed: 2018-10-22
- Assignees: Quadram Institute Bioscience
- Applicants: Quadram Institute Bioscience
- Inventors: Regis Stentz; Simon Carding
- Web page: https://patentgrep.com/patent/US12005106B2

## CPC

- A61K 39/0275: {Salmonella}
- A61K 39/0291: {Yersinia}
- A61K 39/12: Viral antigens
- A61P 37/04: Immunostimulants
- C12N 15/74: Vectors or expression systems specially adapted for prokaryotic hosts other than E. coli, e.g. Lactobacillus, Micromonospora
- A61K 2039/523: {expressing foreign proteins}
- A61K 2039/542: {oral/gastrointestinal}
- A61K 2039/543: {intranasal}
- A61K 2039/55594: {from bacteria}
- A61K 2039/575: {humoral response}
- C12N 2510/00: Genetically modified cells
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates to a vaccine suitable for immunisation against influenza, plague or Y. pestis infection said vaccine comprising outer membrane vesicles (OMVs) and the plague vaccine including the V and/or F1 antigens of Y. pestis.

## Claims

### Claim 1

A mucosal vaccine delivered by oral and/or nasal administration for immunization against plague or Y. pestis infection in animals and humans wherein said vaccine comprises outer membrane vesicles (OMVs) including the V and/or F1 antigens of Y. pestis wherein the OMVs are produced by modified Bacteroides thetaiotaomicron (Bt) wherein the genes or mini-genes encoding the V and/or F1 Y. pestis antigens are cloned downstream of sequences encoding the N-terminal signal peptides of the Bt OMV protein OmpA.

### Claim 2 (depends on 1)

A vaccine according to claim 1 wherein the genes or mini-genes encoding the V and/or F1 Y. pestis proteins are cloned downstream of sequences encoding the N-terminal signal peptides of the Bt OMV protein OmpA.

### Claim 3 (depends on 2)

A vaccine according to claim 2 wherein the protein products are contained within the lumen or outer membrane of OMVs.

### Claim 4 (depends on 1)

A vaccine according to claim 1 wherein the gene constructs are generated in E. coli hosts and then introduced into Bt.

### Claim 5 (depends on 1)

A vaccine according to claim 1 wherein a synthetic gene construct encoding the V antigen and/or a synthetic operon construct encoding caf1M, caf1A and/or caf1 genes of the caf1 operon that generates the F1 protein are N-terminally fused to the OmpA signal peptide of Bt.

### Claim 6 (depends on 5)

A vaccine according to claim 5 wherein gene cassettes are obtained through gene synthesis and subsequently cloned into the E. coli plasmid pEX-A2 and pEX-K4 respectively.