Influenza vaccine composition
View Patent ↗An inactivated influenza virus preparation is described which comprises a haemagglutinin antigen stabilized in the absence of thiomersal, or at low levels of thiomersal, wherein the haemagglutinin is detectable by a SRD assay. The influenza virus preparation may comprise a micelle modifying excipient, for example α-tocopherol or a derivative thereof in a sufficient amount to stabilize the haemagglutinin.
1. An aqueous, inactivated influenza virus preparation comprising a haemagglutinin antigen (HA) stabilised in the absence of thiomersal, or at a level of thiomersal of 5 μg/ml or less, wherein the HA is detectable by a Single Radial Immunodiffusion (SRD) assay, wherein the preparation comprises α-tocopherol succinate in a sufficient amount to stabilise the HA.
2. The inactivated influenza virus preparation according to claim 1 , wherein the α-tocopherol succinate is present at a concentration between 1 μg/ml and 10 mg/ml.
3. The aqueous, inactivated influenza virus preparation according to claim 2 , wherein the α-tocopherol succinate is present at a concentration between 10 and 500 μg/ml.
4. The aqueous, inactivated influenza virus preparation according to claim 1 , wherein the influenza virus antigen preparation is selected from the group of: split virus antigen preparations, subunit antigens, and chemically or otherwise inactivated whole virus.
5. The aqueous, inactivated influenza virus preparation according to claim 1 , wherein the preparation comprises both A and B strain haemagglutinin.
6. The aqueous, inactivated influenza virus preparation according to claim 5 , wherein the preparation is a trivalent influenza virus preparation.
7. The aqueous, inactivated influenza virus preparation according to claim 1 , wherein the stabilised HA is from an influenza B strain.
8. An influenza vaccine comprising the aqueous, inactivated influenza virus preparation according to claim 1 .
9. The influenza vaccine according to claim 8 , wherein the concentration of haemagglutinin antigen for each strain of influenza is 1-1000 μg per ml, as measured by a SRD assay.
10. An influenza vaccine according to claim 8 , wherein the vaccine additionally comprises an adjuvant.
11. A method for preparing the aqueous, inactivated influenza virus preparation of claim 1 which method comprises purifying the antigen in the presence of α-tocopherol succinate.
12. A method for prophylaxis of influenza infection or disease in a subject which method comprises administering to the subject a vaccine according to claim 8 .
13. A method according to claim 12 , in which vaccine delivery is intradermal, intranasal, intramuscular, oral or subcutaneous.
14. The aqueous, inactivated influenza virus preparation according to claim 1 , wherein said influenza virus is a split influenza virus.
15. The aqueous, inactivated influenza virus preparation according to claim 2 , wherein said influenza virus is a split influenza virus.
16. The aqueous, inactivated influenza virus preparation according to claim 3 , wherein said influenza virus is a split influenza virus.