NON-LIVE TRIVALENT INFLUENZA VACCINE FOR ONE-DOSE INTRADERMAL DELIVERY
First Claim
1. A method for inducing a protective immune response in a human population comprising administering intradermally a single dose of a trivalent, non-live influenza vaccine antigen preparation, wherein said protective immune response meets at least one criteria chosen from the group of:
- (1) a protection rate of >
70% in adults of 18-60 years old or of >
60% in elderly people of above 60 years old;
(2) a seroconversion rate of >
40% in adults of 18-60 years old or of >
30% in elderly people of above 60 years old; and
(3) a conversion factor of >
2.5 HI titres in adults of 18-60 years old or of >
2.0 HI titres in elderly people of above 60 years old, is obtained for all three influenza strains.
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Accused Products
Abstract
The invention relates to the use of a trivalent, non-live influenza antigen preparation, particularly a split influenza preparation, in the manufacture of a one-dose influenza vaccine for intradermal delivery. In particular, the invention relates to the use of split influenza preparations wherein the vaccine comprises at least one non-ionic surfactant selected from the group consisting of the octyl- or nonylphenoxy polyoxyethanols (for example the commercially available Triton™ series), polyoxyethylene sorbitan esters (Tween™ series) and polyoxyethylene ethers or esters of general formula (I): HO(CH2CH2O)n-A-R, wherein n is 1-50, A is a bond or —C(O)—, R is C1-50alkyl or phenyl C1-50alkyl; and combinations of two or more of these.
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Citations
18 Claims
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1. A method for inducing a protective immune response in a human population comprising administering intradermally a single dose of a trivalent, non-live influenza vaccine antigen preparation, wherein said protective immune response meets at least one criteria chosen from the group of:
- (1) a protection rate of >
70% in adults of 18-60 years old or of >
60% in elderly people of above 60 years old;
(2) a seroconversion rate of >
40% in adults of 18-60 years old or of >
30% in elderly people of above 60 years old; and
(3) a conversion factor of >
2.5 HI titres in adults of 18-60 years old or of >
2.0 HI titres in elderly people of above 60 years old, is obtained for all three influenza strains. - View Dependent Claims (2, 3, 4, 6, 7, 8, 9, 10, 12, 13, 18)
- (1) a protection rate of >
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5. The method according to claim 5, wherein the vaccine comprises a combination of polyoxyethylene sorbitan monooleate (Tween 80) and t-octylphenoxy polyethoxyethanol (Triton X-100).
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11. The method according to claim 11, wherein the device is a short needle delivery device.
- 14. The pharmaceutical kit according to claim 14, wherein the intradermal delivery device is a short needle device.
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16. A method for inducing a protective immune response in a human population comprising administering intradermally a single dose of a trivalent, non-live influenza vaccine antigen preparation, wherein said protective immune response meets at least two criteria chosen from the group of:
- (1) a protection rate of >
70% in adults of 18-60 years old or of >
60% in elderly people of above 60 years old;
(2) a seroconversion rate of >
40% in adults of 18-60 years old or of >
30% in elderly people of above 60 years old; and
(3) a conversion factor of >
2.5 HI titres in adults of 18-60 years old or of >
2.0 HI titres in elderly people of above 60 years old is obtained for at least two influenza strains.
- (1) a protection rate of >
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17. A method for inducing a protective immune response in a human population comprising administering intradermally a single dose of a trivalent, non-live influenza vaccine antigen preparation, wherein said protective immune response, as assessed by:
- (1) a protection rate of >
70% in adults of 18-60 years old or of >
60% in elderly people of above 60 years old;
(2) a seroconversion rate of >
40% in adults of 18-60 years old or of >
30% in elderly people of above 60 years old; and
(3) a conversion factor of >
2.5 HI titres in adults of 18-60 years old or of >
2.0 HI titres in elderly people of above 60 years old is obtained for all three influenza strains.
- (1) a protection rate of >
Specification