Encapsulated vaccines for the oral vaccination and boostering of fish and other animals

• US 7,998,502 B2
• Filed: 03/24/2009
• Issued: 08/16/2011
• Est. Priority Date: 03/24/2008
• Status: Active Grant

• Current Assignee: Advanced Bionutrition Corporation
• Original Assignee: Advanced Bionutrition Corporation
• Inventors: Harel, Moti
• Primary Examiner(s): Minnifield; Nita M
• Application Number:
  US12/409,607
• Publication Number:
  US 20090238845A1
• Time in Patent Office: 875 Days
• Field of Search: None
• US Class Current: 424/442
• CPC Class Codes: A23K 50/30 for swines
• CPC Class Codes: A23K 50/75 for poultry
• CPC Class Codes: A23K 50/80 for aquatic animals, e.g. fish, crustaceans or molluscs
• CPC Class Codes: A61K 2039/521 inactivated (killed)
• CPC Class Codes: A61K 2039/542 oral/gastrointestinal
• CPC Class Codes: A61K 2039/552 Veterinary vaccine
• CPC Class Codes: A61K 2039/55566 Emulsions, e.g. Freund's adjuvant, MF59
• CPC Class Codes: A61K 2039/55583 Polysaccharides
• CPC Class Codes: A61K 39/0233 Rickettsiales, e.g. Anaplasma
• CPC Class Codes: A61K 39/0275 Salmonella
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 33/02 Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: C12N 2760/16134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: 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

Abstract

The invention relates to a composition comprising a pharmaceutically active agent and a bioadhesive delivery system that provides for the oral delivery of a vaccine to animals, particularly aquatic animals.

Claims

1. A composition for oral administration to an animal for intestinal delivery of a pharmaceutically active agent, said composition comprising:

a) at least one bioadhesive polymer selected from the group consisting of chitosan, hyaluronic acid, cationic guar, and combinations thereof;

wherein the bioadhesive polymer is present at a concentration of between 1% and 10%;

b) at least one oligosaccharide selected from the group consisting of inulin, fructooligosaccharide and dextrin, wherein the oligosaccharide is present at a concentration of between 1% and 50%;

c) at least one mediating compound having both hydrophilic and lipophilic properties, wherein the mediating compound comprises an emulsifier/sugar complex containing 0.5 to 12.5% w/w emulsifier and 5-30% w/w sugar, and d) a pharmaceutically active agent.

2. The composition of claim 1, wherein the mediating compound comprises at least one emulsifier selected from the group consisting of monoglycerides, sorbitan esters, propylene glycol esters, lecithin, polysorbates and sucrose esters, and/or at least one sugar selected from the group consisting of glucose, sucrose and trehalose.

3. The composition of claim 2, wherein the mediating compound is present at a concentration of between 0.1% and 50%.

4. The composition of claim 1, wherein the pharmaceutically active agent is selected from immunogenic peptides and proteins including recombinant vectors to deliver and express genes encoding immunogenic proteins, intact inactive, attenuated and infectious viral particles;

intact killed, attenuated and infectious prokaryotes;

intact killed, attenuated and infectious protozoans and intact killed, attenuated and infectious multicellular pathogens.

5. The composition of claim 1, wherein the pharmaceutically active agent is a Salmon Rickettsial Septicaemia (SRS) vaccine.

7. A method for oral vaccination of an animal for intestinal delivery of a pharmaceutically active agent, comprising:

orally administering to the animal a composition according to claim 1.

8. The method of claim 7, wherein the vaccinated animal is a fish, mammal or bird.

9. The method of claim 8, wherein the fish is a salmonid.

10. The method of claim 9, wherein the oral vaccine comprises a Salmon Rickettsial Septicaemia (SRS) vaccine.

11. The composition of claim 1, wherein the composition is sized for oral delivery and having a particle size from about 10 um to 200 um.

6. A composition for stabilizing and delivery of a pharmaceutically active agent to the gut of a fish, the composition comprising chitosan and inulin in combination with an emulsifier/sugar complex wherein the emulsifier/sugar complex comprises 0.5 to 12.5% w/w emulsifier and 5-30% w/w sugar, wherein the emulsifier/sugar complex comprises lecithin and is in an amount sufficient to mediate the interaction between inulin and the hydrophobic amine residues of chitosan, and wherein the pharmaceutically active agent is a Salmon Rickettsial Septicaemia (SRS) vaccine.