Novel vaccine
AssigneeSmithKline Beecham Biologicals s.a.
InventorsMartin Friede, Veronique Henderickx, Philippe Hermand, Moncef Mohamed Saloui, Sefan Gabriel Jozef Thoelen
Life of this patent
Estimating the term…
Abstract
The invention relates to the use of a non-live influenza virus antigen preparation, particularly a split influenza virus preparation, in the manufacture of a vaccine formulation for a one-dose intranasal vaccination against influenza, wherein the one-dose vaccination meets international regulatory requirements for influenza vaccines. Further provided are methods for the production of the vaccine, and a pharmaceutical kit comprising an intranasal administration device and the one-dose vaccine.
Claims33
A method for prophylaxis of influenza infection or disease in a subject which method comprises administering to the subject, a one-dose intranasal non-live influenza virus antigen preparation, wherein the one-dose intranasal preparation generates an immune response which meets international regulatory requirements for influenza vaccines.
A method for prophylaxis of influenza infection or disease in a subject which method comprises administering to the subject a single dose of a non-live influenza virus vaccine via a mucosal surface to induce an immune response which meets at least two of the following criteria for all strains of influenza present in the vaccine:
- (i) a seroconversion rate of greater than or equal to 40%;
- (ii) a seroprotection rate of greater than or equal to 70%;
- and
- (iii) a conversion factor of greater than or equal to 2.5.
A pharmaceutical kit comprising an intranasal delivery device and a one-dose vaccine which comprises a non-live influenza virus antigen preparation.
A pharmaceutical kit comprising an intranasal delivery device and a one-dose influenza vaccine which generates an immune response that meets the international regulatory requirements for an influenza vaccine.
A pharmaceutical kit comprising an intranasal delivery device and a one-dose vaccine which comprises a low HA dose of a non-live influenza virus antigen preparation.
A method of manufacturing an influenza vaccine for nasal application which method comprises:
- (i) providing a split influenza virus preparation produced essentially as for a conventional injected influenza vaccine and comprising at least one non-ionic surfactant;
- (ii) optionally adjusting the concentration of the haemagglutinin and/or the concentration of non-ionic surfactant in the preparation;
- (iii) filling an intranasal delivery device with a vaccine dose from the split influenza virus preparation, said dose being a suitable volume for intranasal administration, optionally in a bi-dose format.
Dependencies are inferred from the claim text.