Immunization against and treatment for infection by H. pylori
View Patent ↗Methods for treating and/or protecting H. pylori infection are described. The methods utilize non-mucosal administration of an effective amount of one or more H. pylori antigens.
1. A method of protection against infection by H. pylori in a human subject comprising administering intramuscularly and not mucosally to the human subject, an effective amount of a composition consisting essentially of a mixture of H. pylori antigens and coadministering an adjuvant, wherein the adjuvant is aluminum hydroxide, or an adjuvant composition comprising 5% squalene, 0.5% polyoxyelthylenesorbitan monooleate and 0.5% sorbitan trioleate formulated into submicron particles.
2. The method of claim 1 wherein one or more antigens in the mixture separately or in combination elicit a protective immune response.
3. The method of claim 1 , wherein the mixture comprises a virulence factor of H. pylori.
4. The method of claim 3 , wherein the virulence factor of H. pylori is VacA, CagA, NAP or urease.
5. The method of claim 1 , wherein the mixture comprises purified antigen(s).
6. The method of claim 1 , wherein the composition further comprises one or more pharmaceutically acceptable excipients.
7. The method of claim 1 , wherein the mixture comprises a whole cell immunogen.
8. The method of claim 7 , wherein the whole cell immunogen is prepared by extraction from H. pylori cells.
9. The method of claim 8 , wherein the whole cell immunogen is prepared by lysis of H. pylori cells.
10. The method of claim 8 , wherein the whole cell immunogen is prepared by sonication of H. pylori cells.
11. The method of claim 7 , wherein the whole cell immunogen comprises inactivated H. pylori cells.
12. The method of claim 7 , wherein the whole cell immunogen consists of inactivated H. pylori cells.
13. A method for preventing H. pylori infection in a human subject consisting essentially of administering intramuscularly and not mucosally to the human subject, an immunologically effective amount of a composition comprising an H. pylori cell lysate in combination with a pharmaceutically acceptable excipient and an adjuvant, wherein the adjuvant is a composition comprising 5% squalene, 0.5% polyoxyelthylenesorbitan monooleate and 0.5% sorbitan trioleate formulated into submicron particles.
14. A method for preventing H. pylori infection in a human subject consisting essentially of administering intramuscularly and not mucosally to the human subject, an immunologically effective amount of a composition comprising purified H. pylori VacA, CagA and NAP in combination with a pharmaceutically acceptable excipient and an adjuvant, wherein the adjuvant is a composition comprising 5% squalene, 0.5% polyoxyelthylenesorbitan monooleate and 0.5% sorbitan trioleate formulated into submicron particles.