# US 2014/0193460 A1 · Herpes virus vaccine and methods of use

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- Number: US 2014/0193460 A1
- Document ID: US20140193460A1
- Status: Published application
- Kind: A1
- Application number: 14/141,251
- Filed: 2013-12-26
- Published: 2014-07-10
- Earliest claimed: 2011-07-01
- Assignees: The Regents of the University of California
- Applicants: The Regents of the University of California
- Inventors: Deborah H. Spector; Christopher S. Morello; Kimberly A. Kraynyak
- Web page: https://patentgrep.com/patent/US20140193460A1

## CPC

- A61K 39/245: Herpetoviridae, e.g. herpes simplex virus
- A61K 39/12: Viral antigens
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/22: for herpes viruses
- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 2039/5252: {inactivated (killed)}
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55572: {Lipopolysaccharides; Lipid A; Monophosphoryl lipid A}
- C12N 2710/16634: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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)

## Abstract

Provided herein are, inter alia, vaccines and methods of using the same for the treatment or prevention of Herpesvirus infections.

## Claims

### Claim 1

A Herpesvirus (HV) vaccine comprising inactivated HV, a lipopolysaccharide (LPS)-derived adjuvant and an aluminum-based mineral salt adjuvant.

### Claim 2 (depends on 1)

The vaccine of claim 1,
wherein said LPS-derived adjuvant is MPL;
said aluminum-based mineral salt adjuvant is aluminum hydroxide adjuvant or aluminum phosphate adjuvant; and
said vaccine does not comprise an isolated nucleic acid sequence formulation.

### Claim at position 3

-8. (canceled)

### Claim 9 (depends on 1)

The vaccine of claim 1, wherein said HV is a Herpes Simplex Virus (HSV).

### Claim at position 5

-17. (canceled)

### Claim 18 (depends on 9)

The vaccine of claim 9, wherein said lipopolysaccharide-derived adjuvant is monophosphoryl lipid A (MPL)

### Claim at position 7

-20. (canceled)

### Claim 21 (depends on 9)

The vaccine of claim 9, wherein said lipopolysaccharide-derived adjuvant is capable of binding the TLR4 protein.

### Claim 22 (depends on 9)

The vaccine of claim 9, wherein said lipopolysaccharide-derived adjuvant is a synthetic MPL analogue adjuvant.

### Claim at position 10

-28. (canceled)

### Claim 29 (depends on 9)

The vaccine of claim 9, wherein said inactivated HV comprises a replication decreasing DNA mutation.

### Claim 30 (depends on 9)

The vaccine of claim 9, wherein said inactivated HV is formed by chemical inactivation.

### Claim 31 (depends on 9)

The vaccine of claim 9, wherein said inactivated HV is formed by contacting said HV with one or more agents selected from a cross-linking agent, oxidizing agent, reducing agent, heat, radiation, detergent, a pH changing agent, and a chemical agent selected from a furocoumarin, aziridine, ethylenimine, binary ethylenimine, and beta-propiolactone.

### Claim at position 14

-33. (canceled)

### Claim 34

A method of preparing a Herpesvirus (HV) vaccine, said method comprising:
(i) contacting an HV-cell mixture with a sulfated or sulfonated polysaccharide, wherein said HV-cell mixture comprises HV particles, cells and portions of cells;
(ii) separating said HV particles from said cells thereby forming isolated HV particles;
(iii) inactivating said isolated HV particles thereby forming inactivated HV particles;
(iv) combining said inactivated HV particles with a lipopolysaccharide-derived adjuvant and an aluminum-based mineral salt adjuvant thereby forming an HV vaccine.

### Claim 35 (depends on 34)

The method of claim 34, wherein said HV is an HSV.

### Claim at position 17

-80. (canceled)

### Claim 81 (depends on 35)

The method of claim 35, wherein said sulfated or sulfonated polysaccharide is selected from dextran sulfate, heparin, and heparan sulfate.

### Claim at position 19

-100. (canceled)

### Claim 101 (depends on 35)

The method of claim 35, wherein said inactivating comprises contacting said HV with one or more agents selected from a cross-linking agent, oxidizing agent, reducing agent, heat, radiation, detergent, a pH changing agent, and a chemical agent selected from a furocoumarin, aziridine, ethylenimine, binary ethylenimine, and beta-propiolactone.

### Claim at position 21

-125. (canceled)

### Claim 126 (depends on 9)

A method of treating or preventing HV infection in a patient in need of such treatment or prevention, said method comprising administering a therapeutically or prophylactically effective amount of the HV vaccine of claims 9.

### Claim at position 23

127-131. (canceled)

### Claim 132 (depends on 9)

A method of treating or preventing a disease in a patient in need of such treatment or prevention, said method comprising administering a therapeutically or prophylactically effective amount of the HV vaccine of claim 9.

### Claim 133

(canceled)

### Claim 134 (depends on 132)

The method claim 132, wherein said HV is an HSV.

### Claim at position 27

-137. (canceled)

### Claim 138 (depends on 134)

The method of claim 134, wherein said disease is selected from the group consisting of herpetic gingivostomatitis, herpes labialis, herpes genitalis, herpetic whitlow, herpes gladiatorum, herpesviral encephalitis, herpesviral meningitis, herpes esophagitis, herpes keratitis, Bell's palsy, Mollaret's meningitis, herpes rugbeiorum, eczema herpeticum, herpetic neuralgia, and post-herpetic neuralgia.

### Claim at position 29

-178. (canceled)

### Claim 179 (depends on 138)

The method of claim 138, consisting of a prime-boost administration of said HSV vaccine.

### Claim 180 (depends on 138)

The method of claim 138, consisting of a prime-boost-boost administration of said HSV vaccine.

### Claim 181 (depends on 9)

A kit comprising the HV vaccine of claim 9 and instructions for administering said HV vaccine to a patient.

### Claim 182

(canceled)