초록 ▼

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 th

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 C1-50 alkyl or phenyl C1-50 alkyl; and combinations of two or more of these.

대표청구항 ▼

1. A method for inducing a protective immune response in a human population of at least 18 years old comprising administering intradermally a single dose of a trivalent, split or subunit influenza vaccine antigen preparation using a short needle device, wherein the single dose results in said protec

1. A method for inducing a protective immune response in a human population of at least 18 years old comprising administering intradermally a single dose of a trivalent, split or subunit influenza vaccine antigen preparation using a short needle device, wherein the single dose results in said protective immune response meeting at least one criterion 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, for each influenza strain. 2. The method according to claim 1, wherein the influenza antigen is egg-derived. 3. The method according to claim 1, wherein the vaccine comprises at least one non-ionic surfactant selected from the group consisting of an octyl-or nonylphenoxy polyoxyethanol, polyoxyethylene sorbitan ester and a polyoxyethylene ether or ester of general formula (I): HO(CH2CH2O)n-A-R (I) wherein n is 1-50, A is a bond or —C(O)—, R is C1-50 alkyl or phenyl C1-50 alkyl. 4. The method according to claim 3, wherein the vaccine comprises a combination of polyoxyethylene sorbitan monooleate (Tween 80) and t-octylphenoxy polyethoxyethanol (Triton X-100). 5. The method according to claim 1, wherein the vaccine further comprises a bile acid or cholic acid, or derivative thereof. 6. The method according to claim 1, wherein the vaccine is provided in a dose volume of between about 0.1 and about 0.2 ml. 7. The method according claim 1, wherein the vaccine further comprises an adjuvant comprising a combination of cholesterol, a saponin and an LPS derivative. 8. The method according to claim 1, wherein said influenza vaccine antigen preparation is obtained by a process comprising: (i) harvesting virus-containing material from a culture; (ii) clarifying the harvested material to remove non-virus material; (iii) concentrating the harvested virus; (iv) separating whole virus from non-virus material; (v) splitting the whole virus using a suitable splitting agent in a density gradient centrifugation step; and (vi) filtering the product of step (v) to remove undesired materials. 9. A method for inducing a protective immune response in a human population of at least 18 years old comprising administering intradermally a single dose of a trivalent, split or subunit influenza vaccine antigen preparation using a short needle device, 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, for each influenza strain. 10. A method for inducing a protective immune response in a human population of at least 18 years old comprising administering intradermally a single dose of a trivalent, split or subunit influenza vaccine antigen preparation using a short needle device, wherein said protective immune response meets all criteria chosen from the group: (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, for each influenza strain. 11. The method according to claim 5, wherein the cholic acid derivative is sodium deoxycholate. 12. The method according to claim 1, wherein the influenza vaccine antigen preparation comprises two A strains and one B strain.