Claims for Patent: 9,901,630

Summary for Patent: 9,901,630

Title:	Adjuvant-sparing multi-dose influenza vaccination regimen
Abstract:	An influenza vaccine is administered by a multi-dose regimen, in which (i) a first dose is administered with an adjuvant and (ii) a later dose is administered either without an adjuvant or with a different adjuvant. Thus the invention provides the benefits of a two-dose regimen without also doubling the supply need for a given adjuvant.
Inventor(s):	Del Giudice; Giuseppe (Siena, IT), Manetti; Riccardo (Siena, IT)
Assignee:	Seqirus UK Limited (Maidenhead, Berkshire, GB)
Application Number:	14/326,299
Patent Claims:	1. A method for immunizing a patient against an influenza virus infection with a two-dose regimen, the method comprising a step of: administering to a patient a second dose of an influenza virus vaccine by a second route of administration, wherein the patient has previously received within a single influenza season a first dose of the influenza virus vaccine by a first route of administration; wherein the first dose comprises a first adjuvant; wherein the first route of administration is the same as the second route of administration; further wherein the second dose of the influenza virus vaccine does not comprise the first adjuvant. 2. The method of claim 1, wherein the patient has previously received the first dose at least about 2 weeks, about 3 weeks, about 4 weeks, about 6 weeks, about 8 weeks, about 10 weeks, about 12 weeks, or about 16 weeks prior within the single influenza season. 3. The method of claim 1, wherein the second dose comprises a second adjuvant, and wherein the second adjuvant is different from the first adjuvant. 4. The method of claim 1, wherein the first and second route of administration is by intramuscular injection. 5. The method of claim 1, wherein the first dose is adjuvanted with an oil-in-water emulsion adjuvant. 6. The method of claim 5, wherein the oil-in-water emulsion adjuvant comprises squalene. 7. The method of claim 6, wherein the oil-in-water emulsion adjuvant comprises squalene and one or more surfactants. 8. The method of claim 7, wherein the oil-in-water emulsion adjuvant comprises 0.1-1% surfactants. 9. The method of claim 7, wherein the oil-in-water emulsion adjuvant comprises squalene, polysorbate 80, and sorbitan trioleate. 10. The method of claim 1, wherein the influenza virus vaccine comprises an influenza virus antigen selected from the group consisting of: H1, H2, H3, H5, H7 and H9 influenza A virus subtypes. 11. A method for immunizing a patient against at least one influenza virus infection with a two-dose regimen, comprising the steps of: (i) administering a first dose of an influenza virus vaccine comprising at least an inactivated influenza antigen in combination with a first adjuvant which comprises an oil-in-water emulsion; and (ii) administering a further dose of the influenza virus vaccine, wherein the further dose of the influenza virus vaccine does not comprise the first adjuvant, within six months after administering the dose in step (i). 12. The method of claim 11, wherein the further dose is administered by the same route as the first dose. 13. The method of claim 11, wherein the further dose is adjuvanted with an adjuvant that is different from the first adjuvant. 14. The method of claim 11, wherein the oil-in-water emulsion includes a terpenoid. 15. The method of claim 14, wherein the terpenoid is squalene. 16. The method of claim 11, wherein the oil-in-water emulsion includes polyoxyethylene sorbitan monooleate, sorbitan trioleate, lecithin or octoxynol-9. 17. The method of claim 11, wherein the first and/or further doses of the influenza virus vaccine comprise antigens from 2, 3, or 4 influenza virus strains. 18. The method of claim 11, wherein the further dose of the influenza virus vaccine and the first dose are both administered by intramuscular injection. 19. The method of claim 11, wherein the first and/or further doses of the influenza virus vaccine are administered to a patient less than 1 year old, 1-5 years old or 5-15 years old. 20. The method of claim 11, wherein the first and further doses of the influenza virus vaccine share at least one common hemagglutinin subtype. 21. The method of claim 11, wherein the first and further doses of the influenza virus vaccine comprise antigens from pandemic influenza strains. 22. The method of claim 11, wherein the first and further doses of the influenza virus vaccine comprise an antigen from H5N1, H5N3, H9N2, H2N2, H7N1 or H7N7 influenza.

Details for Patent 9,901,630

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Seqirus Vaccines Limited	FLUVIRIN	influenza virus vaccine	Injection	103837	11/03/1998		2026-06-15
Sanofi Pasteur Inc.	FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT	influenza virus vaccine	Injection	103914	12/09/1999		2026-06-15
Sanofi Pasteur Inc.	FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT	influenza virus vaccine	Injection	103914	12/23/1909		2026-06-15
Sanofi Pasteur Inc.	FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT	influenza virus vaccine	Injection	103914	05/09/2011		2026-06-15
Sanofi Pasteur Inc.	FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT	influenza virus vaccine	Injection	103914	06/07/2013		2026-06-15
Sanofi Pasteur Inc.	FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT	influenza virus vaccine	Injection	103914	12/11/2014		2026-06-15
Sanofi Pasteur Inc.	FLUZONE, FLUZONE HD QUADRIVALENT, FLUZONE HIGH DOSE, FLUZONE INTRADERMAL, FLUZONE QUADRIVALENT	influenza virus vaccine	Injection	103914	11/04/2019		2026-06-15