Oral administration of antigens

• US 5,352,448 A
• Filed: 07/20/1992
• Issued: 10/04/1994
• Est. Priority Date: 07/20/1992
• Status: Expired due to Fees

• Current Assignee: Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Original Assignee: Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Inventors: Bowersock, Terry L., Levy, Michel, Shalaby, Waleed S. W., Blevins, William E., Park, Kinam
• Primary Examiner(s): Nucker, Christine M.
• Assistant Examiner(s): DUBRULE, CHRISTOPHER
• Application Number:
  US07/916,533
• Time in Patent Office: 806 Days
• Field of Search: 427/88, 427/92, 427/424, 427/426, 427/486, 427/487, 427/435, 427/436, 427/438
• US Class Current: 424/438
• CPC Class Codes: A61K 9/1635 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: Y10S 424/823 Bacterial vaccine for bovine species, e.g. cattle

Abstract

An oral vaccine formulation is provided for stimulation of an immune response in gut-associated lymphoid tissues. The formulation comprises an enzymatically degradable antigen in a hydrogel matrix. In ruminant species, the vaccine formulation, upon oral administration, is formed to pass through the rumen without substantial hydration and then into the post-ruminal portion of the digestive tract where the antigen is released for contact with the gut-associated lymphoid tissue.

Claims

1. An oral vaccine composition for ruminant species said composition comprising

an antigenic composition in an amount effective to induce an immune response in gut-associated lymphoid tissue of said ruminant species in a delivery vehicle consisting essentially of a water swellable hydrogel matrix in the form of pellets having a volume of about 3 to about 75 mm³ and an air-dried density of about 1.1 to about 1.4 g/cc for hydration int he post-ruminal portion of the digestive tract of said species and release of said antigenic composition for contact with the gut-associated lymphoid tissue.

2. The composition of claim 1, wherein the hydrogel matrix is combined with the antigenic composition by hydrating the hydrogel matrix in a solution of the antigenic composition and drying the hydrated matrix.

3. The composition of claim 1, wherein the antigenic composition is a mixture of antigens obtained from the culture supernatant of a bacterial culture.

4. A method of vaccinating ruminants by stimulating the gut-associated lymphoid tissue with an antigenic composition said method comprising the step of orally administering a vaccine composition in accordance with claim 1.

5. The method of claim 4, wherein the vaccine composition is administered in admixture with animal feed.

6. The method of claim 4, wherein the vaccine composition is administered in a bolus dosage form.

8. A method of forming the composition of claim 1, said method comprising the steps of

forming an aqueous solution comprising the antigenic composition,

about 30 to about 50 percent weight of a hydrogel forming monomer or a cross-linkable hydrogel-forming polymer, and about 0.01 to about 5% of a cross-linking agent,

initiating hydrogel formation, and

drying the resulting hydrogel-antigen composition.

9. A method of forming the composition of claim 1, said method comprising the steps of

forming the hydrogel matrix in a pelletized form,

drying the hydrogel pellets,

forming an aqueous solution of the antigenic composition,

combining the hydrogel pellets with the aqueous solution and allowing the pellets to rehydrate,

removing the pellets from the aqueous solution and drying the pellets.

7. An orally administered ruminant vaccine composition comprising a proteolytically degradably antigenic composition in a delivery vehicle consisting essentially of a swellable hydrogel matrix in the form of pellets having a volume of about 3 to about 75 mm³ and an air-dried density of about 1.1 to about 1.4 g/cc, said antigenic composition releasable from said hydrogel matrix upon swelling of the matrix in the post-ruminal portion of the ruminant digestive tract.

10. A method of vaccinating ruminant species by stimulating the gut-associated lymphoid tissue with an antigenic composition, said method comprising the step of orally administering to said ruminant species a vaccine composition comprising the antigenic composition in a delivery vehicle consisting essentially of a hydrogel matrix in the form of pellets having a volume of about 3 to about 75 mm³ and an air-dried density of about 1.1 to about 1.4 g/cc, swellable in the post-ruminal portion of the digestive tract of the ruminant species with resultant release of the antigenic composition for stimulation of the gut-associated lymphoid tissue of said ruminant species.