Edible vaccines expressed in soybeans

• US 20070192905A1
• Filed: 10/12/2005
• Published: 08/16/2007
• Est. Priority Date: 10/12/2004
• Status: Active Grant

• Current Assignee: SoyMeds, Inc.
• Original Assignee: University of South Carolina
• Inventors: Piller, Kenneth, Bost, Kenneth
• Granted Patent: US 7,723,570 B2
• Time in Patent Office: Days
• US Class Current: 800/288
• CPC Class Codes: A61K 2039/517 Plant cells
• CPC Class Codes: A61K 2039/55544 Bacterial toxins
• CPC Class Codes: A61K 39/0005 Vertebrate antigens from snakes A61K39/38
• CPC Class Codes: A61K 39/02 Bacterial antigens
• CPC Class Codes: A61K 39/0258 Escherichia
• CPC Class Codes: A61K 39/35 Allergens
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/14 for RNA viruses
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 31/22 for herpes viruses
• CPC Class Codes: C12N 15/8258 for the production of oral vaccines (antigens) or immunoglobulins
• CPC Class Codes: C12N 2710/00088 for redistribution
• 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 present invention relates to vaccines that are made in transgenic soybeans for use in humans, animals of agricultural importance, pets, and wildlife. These vaccines are used as vaccines against viral, bacterial, fungal, parasitic or prion related diseases, cancer antigens, toxins, and autologous or self proteins. The transgenic soybeans of the instant invention also can be used for inducing tolerance to allergens or tolerance to autoimmune antigens, wherein an individual shows hypersensitivity to said allergen or has developed autoimmunity to autologous or self proteins, respectively. The invention also relates to prophylatically treating individuals and/or populations prior to showing hypersensitivity to allergens. Other aspects of the invention include using the transgenic soybeans as an oral contraceptive, and the expression of protein adjuvants in transgenic soybeans.

Claims

1. A vaccine comprising a transgenic soybean wherein the transgenic soybean is transformed with an exogenous nucleotide sequence that expresses an immunogen wherein said immunogen produces an immunogenic response upon oral administration to an individual and wherein the exogenous nucleotide sequence expresses one or more members selected from the group consisting of a bacterial immunogen, a viral immunogen, a fungal immunogen, a parasitic immunogen, a microbial toxin, an oral contraceptive protein, and a prion protein.

2. The vaccine according to claim 1, wherein the vaccine is against microbial diseases and the immunogenic response is selected from the group consisting of:

A) memory T helper lymphocyte response;

B) memory cytotoxic T lymphocyte response; and

C) memory B lymphocyte response.

3. The vaccine according to claim 1, wherein the immunogen is selected from the group consisting of fanC, SEB (Staph enterotoxin B), bee venom phospholipase A2 (PLA2), E. coli heat labile toxin(LT adjuvant), Bacillus anthracis toxins, PA toxin, LF toxin, EF toxin, Clostridium tetani exotoxins, Clostridium botulinum toxin, HIV protein gp120, HIV protein gp41, HIV protein Gag, HIV protein RT, SARS Coronavirus Spike glycoprotein, SARS Coronavirus nucleocapsid, HSV-2 gB scaffolding protein, HSV-2 scaffolding gD protein, smallpox core proteins, smallpox membrane proteins, encephalitis nsProteins 1-4 and encephalitis spike proteins.

4. The vaccine according to claim 1, further comprising an adjuvant.

5. The vaccine according to claim 4, wherein the adjuvant is selected from the group consisting of mutant E. coli heat labile toxin-(mLT) and mutant cholera toxin (mCT).

6. The vaccine according to claim 1, wherein the vaccine is against self antigens and the vaccine comprises a transgenic soybean, wherein the transgenic soybean is transformed with an exogenous nucleotide sequence that expresses an immunogen wherein said immunogen produces an immunogenic response upon oral administration to an individual and wherein the exogenous nucleotide sequence expresses one or more members selected from the group consisting of oral contraceptive proteins, cancer proteins, and prion proteins.

7. The vaccine according to claim 6, wherein the immunogenic response is selected from the group consisting of:

A) memory T helper lymphocyte response;

B) memory cytotoxic T lymphocyte response; and

C) memory B lymphocyte response.

8. The vaccine according to claim 6, wherein the one or more members is/are oral contraceptive proteins or cancer antigens selected from the group consisting of Gonadotrophin releasing hormone, Zona pellucida protein ZPA, Zona pellucida protein ZPB, Epididymal protease inhibitor (Eppin), Chorionic gonadotrophin, MART-1, PSMA, HER-2/neu CEA and prion protein.

9. The vaccine according to claim 6, further comprising an adjuvant.

10. The vaccine according to claim 9, wherein the adjuvant is selected from the group consisting of mutant E. coli heat labile toxin (mLT) and mutant cholera toxin (mCT).

11. A bacterial toxin-based mucosal adjuvant comprising a transgenic soybean, wherein the transgenic soybean is transformed with an exogenous nucleotide sequence that expresses a protein that accentuates development of one or more of the following responses:

A) memory T helper lymphocyte response;

B) memory cytotoxic T lymphocyte response;

or C) memory B lymphocyte response, when the adjuvant administration is given in conjunction with a vaccine.

12. The bacterial toxin-based mucosal adjuvant according to claim 11, wherein the adjuvant is given to an individual contemporaneously with a vaccine.

13. The bacterial toxin-based mucosal adjuvant according to claim 11, wherein the adjuvant is selected from the group consisting of mutant E. coli heat labile toxin (mLT) and mutant cholera toxin (mCT).

14. The bacterial toxin-based mucosal adjuvant according to claim 11, wherein the adjuvant is mutant E. coli heat labile toxin (mLT).

15. The bacterial toxin-based mucosal adjuvant according to claim 12, wherein the adjuvant is mutant E. coli heat labile toxin (mLT).

16. A toleragen comprising a transgenic soybean, wherein the transgenic soybean is transformed with an exogenous nucleotide sequence that expresses a protein that upon oral administration induces mucosal and/or systemic tolerance.

17. The toleragen according to claim 16, wherein the toleragen is one or more members selected from the group consisting of an allergen and an autoimmune antigen.

18. The toleragen according to claim 16, wherein the toleragen is administered prophylactically.

19. The toleragen according to claim 16, wherein the toleragen is administered therapeutically.

20. The toleragen according to claim 16, wherein the toleragen is one or more autoimmune proteins selected from the group consisting of, acetylcholine receptor, Myelin basic protein, and Type II collagen or one or more allergens derived from Ambrosia, Dermatophagoides, Juniperous, Feline and Arachis.