Immunopotentiating formulations for vaccinal use

• US 6,355,414 B1
• Filed: 01/06/2000
• Issued: 03/12/2002
• Est. Priority Date: 03/06/1997
• Status: Expired due to Fees

• Current Assignee: Centro De Ingenieria Genetica Y Biotecnologia
• Original Assignee: Centro De Ingenieria Genetica Y Biotechnologia
• Inventors: Guillen Nieto, Gerardo Enrique, Iglesias Perez, Enrique, Aguilar Rubido, Julio Cesar, Cruz Ricondo, Luis Javier, Muzio Gonzalez, Verena Lucila, Penton Arias, Eduardo, Veliz Rios, Gloria, Leal Angulo, Maria de Jesus, Madrazo Piñol, Juan Joel, Mesa Pardillo, Cirse, Hechavarria Gay, Maydel, Diaz Martinez, Maylin, Carmenate Portilla, Tania, Herrera Buch, Antonieta, Pichardo Diaz, Dagmara
• Primary Examiner(s): SALIMI, ALI REZA
• Application Number:
  US09/380,790
• Time in Patent Office: 796 Days
• Field of Search: 424/278.1, 435/5, 514/54, 514/885
• US Class Current: 435/5
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/543 intranasal
• CPC Class Codes: A61K 2039/55544 Bacterial toxins
• CPC Class Codes: A61K 2039/55583 Polysaccharides
• CPC Class Codes: A61K 2039/55588 Adjuvants of undefined constitution
• CPC Class Codes: A61K 39/095 Neisseria
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/292 Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
• CPC Class Codes: C12N 2730/10134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: Y10S 977/906 Drug delivery

Abstract

The present invention is related to the field of medicine, particularly to the use of new adjuvant formulations with vaccine antigens. The technical objective pursued with this invention is, precisely, the development of formulations that are able to increase and/or modulate the immune response of the organism to vaccine antigens in the serum and the mucous lining. With this aim, a formulation was developed that contained as the main components the surface antigen of the hepatitis B virus and the acemannan in adequate proportions. As an extension of this result, formulations were developed in which a) HBsAg was used as the homologous or heterologous antigen carrier b) delivery systems of particulated antigens and c) soluble antigens, combined with the acemannan in specific proportions. The formulations of this invention are applicable in the pharmaceutical industry as vaccine formulations for human and veterinary use.

Claims

1. A method for potentiating an immune response to antigens comprising:

administering a formulation comprising a subunit particulated antigen; and

acemannan polysaccharide, wherein the administration is by mucosal administration.

2. A method according to claim 1 wherein the mucosal administration is nasopharyngeal administration.

3. A method according to claim 1 wherein acemannan concentration is in the range of 0.070 mg/mL to 0.550 mg/mL of hexose concentration.

4. A method according to claim 1 wherein the subunit particulated antigen is the Neisseria meningitidis 5C outer membrane protein.

5. A method according to claim 4, wherein the subunit particulated antigen of Neisseria meningitidis 5C outer membrane protein is obtained by adsorption, trapping, covalent linking or electrostatic association to a delivery system.

6. A method according to claim 4, wherein the dose of the 5C antigen is in a range up to 500 μ

g of protein.

7. A method according to claim 5, wherein the antigen submitted to particulation is a viral, bacterial or uni or multicellular parasite.

8. A method according to claim 5, wherein the antigen is natural, recombinant, or synthetic.

9. A method for potentiating an immune response to antigens comprising:

administering a formulation comprising a subunit particulated recombinant hepatitis B surface antigen; and

acemannan polysaccharide, wherein the administration is by mucosal administration.

10. A method according to claim 9 wherein the mucosal administration is nasopharyngeal administration.

11. A method according to claim 9 wherein the dose of hepatitis B surface antigen is between 2 μ

g and 500 μ

g.

12. A method according to claim 9 wherein the subunit particulated hepatitis B surface antigen is covalently coupled to soluble antigens.

13. A method according to claim 12 wherein the coupled antigen is a homologous or heterologous antigen and the total antigen dose is between 2 μ

g and 500 μ

g of protein.

14. A method according to claim 9 wherein the acemannan is an extract of Aloe barbadensis Miller plants wherein the extract has immunopotentiating activity.

15. A method according to claim 9 wherein said response is potentiated in a human or animal.