Edible vaccines expressed in soybeans

• US 7,723,570 B2
• Filed: 10/12/2005
• Issued: 05/25/2010
• Est. Priority Date: 10/12/2004
• Status: Active Grant

• Current Assignee: SoyMeds, Inc.
• Original Assignee: SoyMeds, Inc.
• Inventors: Piller, Kenneth John, Bost, Kenneth Lee
• Primary Examiner(s): Worley; Cathy Kingdon
• Application Number:
  US11/249,182
• Publication Number:
  US 20070192905A1
• Time in Patent Office: 1,686 Days
• Field of Search: None
• 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. An immunogen comprising a transgenic soybean and a mutant cholera toxin adjuvant, wherein the transgenic soybean is transformed with an exogenous nucleotide sequence that expresses recombinant SEB (Staphylococcus enterotoxin B) and wherein said immunogen produces a protective immunogenic response upon oral administration to an animal.

2. The immunogen according to claim 1, wherein the transgenic soybean is transformed with the exogenous nucleotide sequence by Agrobacterium mediated transformation.

3. The immunogen according to claim 1, wherein the protective 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.

4. An immunogen comprising a soy product and a mutant cholera toxin adjuvant, wherein the soy product is selected from the group consisting of soybean seed, soy milk, soy powder, soy flour, and soy flakes;

and wherein the soy product comprises recombinant SEB that was produced in transgenic soybeans.

5. A method of producing an immunogen comprising a transgenic soybean or soy protein product made therefrom and a mutant cholera toxin adjuvant, said method comprising:

transforming a soybean with an exogenous nucleotide sequence that expresses SEB;

wherein the mutant cholera toxin adjuvant is coexpressed with the SEB or is added separately to the transgenic soybean or soy protein product.

6. The method of claim 5, further comprising a step wherein the SEB is processed into a soy protein product.

7. The method of claim 6, wherein the soy protein product is in a form selected from the group consisting of soybean seed, soy milk, soy powder, soy flour, and soy flakes.

8. The method of claim 7, wherein the exogenous nucleotide sequence is operationally linked to a seed specific promoter.

9. A method of prophylactically treating an individual with the immunogen of claim 1, wherein said immunogen produces a protective immunogenic response upon oral administration to said individual.

10. The method of claim 9, wherein SEB is coexpressed as a fusion protein with another protein or peptide which targets binding to epithelial cells in the gastrointestinal tract.

11. The method of claim 9, wherein the immunogen is administered in a soy protein product form selected from the group consisting of soybean seed, soy milk, soy powder, soy flour, and soy flakes.

12. The method of claim 5, wherein the step of transforming is carried out by transferring the exogenous nucleotide sequence into an Agrobacterium, and infecting a soybean plant with the Agrobacterium thereby transforming the soybean plant.

13. The immunogen according to claim 1, wherein the immunogen comprises a transgenic soybean that is transformed with the exogenous nucleotide sequence that expresses SEB and an exogenous nucleotide sequence that expresses the mutant cholera toxin adjuvant wherein said immunogen produces a protective immunogenic response upon oral administration to an animal.

14. The immunogen according to claim 1, wherein at least 1% of the total protein of the transgenic soybean comprises the protein antigen expressed from the exogenous nucleotide sequence.

15. The method of claim 5, further comprising a step wherein the SEB and the mutant cholera toxin co-expressed are processed into a soy protein product.

16. The method of claim 9, wherein the immunogen is administered in a soy milk form.