# US 12,005,110 B2 · Honeybee commensal Snodgrassella alvi vaccine against pathogenic Neisseriaceae

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- Number: US 12,005,110 B2
- Document ID: US12005110B2
- Status: Granted
- Kind: B2
- Application number: 17/431,281
- Filed: 2020-02-14
- Published: 2022-04-28
- Granted: 2024-06-11
- Earliest claimed: 2019-02-14
- Assignees: University of Florida Research Foundation, Inc.
- Applicants: University of Florida Research Foundation, Incorporated
- Inventors: Massimo Maddaloni; David Wayne Pascual
- Web page: https://patentgrep.com/patent/US12005110B2

## CPC

- A61K 39/095: Neisseria
- A61K 31/7024: Esters of saccharides
- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 31/04: Antibacterial agents
- A61K 2039/522: {avirulent or attenuated}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- 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

## Abstract

Embodiments herein include an attenuated live vaccine composition for protection against Neisseria spp. infection, the vaccine composition comprising an effective amount of Snodgras sella alvi (S. alvi), or an antigen component thereof, and methods for treating or preventing disease related to or aggravated by Neisseria gonorrhoea is provided.

## Claims

### Claim 1

A method for immunizing a subject against Neisseria gonorrhoeae infection, comprising administering to the subject an attenuated live vaccine composition for protection against Neisseria gonorrhoeae infection, the vaccine composition comprising an effective amount of Snodgrassella alvi (S. alvi), and an adjuvant.

### Claim 2 (depends on 1)

The method of claim 1, wherein the vaccine is administered to the subject in four (4) doses.

### Claim 3 (depends on 2)

The method of claim 2, wherein each dose comprises between 5×104 and 5×109 CFUs of S. alvi.

### Claim 4 (depends on 1)

The method of claim 1, wherein the administration occurs intraperitoneally (IP), intradermally (ID), intramuscularly (IM), or subcutaneously (subQ), intranasally, intraorally, intravaginally, or via the para-genito-urinary tract, or a combination thereof.

### Claim 5 (depends on 4)

The method of claim 4, wherein the first and second doses are administered parenterally, by intradermal, intramuscular, subcutaneous administration, or by intraperitoneal administration.

### Claim 6 (depends on 4)

The method of claim 4, wherein 75% of the third dose is administered intraperitoneally, and 25% of the third dose is administered subcutaneously.

### Claim 7 (depends on 2)

The method of claim 2, wherein the doses are administered at weeks 1, 3, 7, and 26.

### Claim 8

A method of treating or preventing disease related to or aggravated by Neisseria gonorrhoeae infection in a subject in need thereof comprising administering to the subject a composition comprising an attenuated live vaccine composition for protection against Neisseria gonorrhoeae infection, the vaccine composition comprising an effective amount of Snodgrassella alvi (S. alvi), and an adjuvant.

### Claim 9 (depends on 1)

The method of claim 1, wherein the S. alvi strain comprises wkB12, pAJ198, or wkB2.

### Claim 10 (depends on 1)

The method of claim 1, wherein the adjuvant comprises a toll-like receptor (TLR) agonist, comprising, MPL, alum, or a combination thereof.