Vaccine composition for naive subjects
AssigneeEurocine Vaccines AB
InventorsHans Arwidsson, Anna-Karin Maltais
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Abstract
The invention relates to nasally-administered vaccine compositions effective in naive subjects such as children. Further, the vaccine composition is suitable for vaccinating the general population during a pandemic. One aspect of the invention is directed to the paediatric use of the vaccine of the invention including a vaccine effective in children against seasonal influenza virus strains. A further aspect of the invention is directed to subjects of all age groups when the composition is for pandemic use.
Claims35
A composition comprising
- one or more non-live antigens, and
- an adjuvant comprising:
- one or more carboxylic acids,
- an aqueous medium, and
- optionally one or more mono-glycerides
- for use as an intranasally administered vaccine for use in naive subjects.
A composition for use according to any of the preceding claims, wherein said vaccine is for pediatric use.
A composition for use according to any of the preceding claims, wherein said vaccine is for use in influenza naive subjects.
A composition for use according to any of the preceding claims, wherein said composition is for use in naive subjects for reducing virus shedding.
A composition for use according to any of the preceding claims, wherein said vaccine is for use in children.
A composition for use according to any of the preceding claims, wherein the children are less than 8 years of age, such as 6 years old or less.
A composition for use according to any of the preceding claims, wherein the children are of age 2 months to less than 9 years old, such as of age 6 months to less than 8 years old, preferably of age 6 month to less than 7 years old.
A composition for use according to any of the preceding claims for use as an influenza vaccine.
A composition for use according to any of the preceding claims, wherein said vaccine is for immunization against influenza in influenza naïve subjects.
A composition for use according to any of the preceding claims wherein the naive subjects are selected from the group consisting of children less than 12 years of age and persons of any age in a pandemic zone.
A composition for use according to any of the preceding claims, wherein said vaccine is for immunization against a peri-pandemic or pandemic infectious pathogen.
A composition for use according to any of the preceding claims, wherein said vaccine is for immunization against a pandemic infectious pathogen in infants, children and adults.
A composition for use according to any of the preceding claims, wherein said vaccine is for immunization against an infectious pathogen in infants, children and adults.
A composition for use according to any of the preceding claims wherein the non-live influenza virus antigen is selected from the group consisting of a whole inactivated virus, a split virus, and a subunit influenza antigen.
A composition for use according to any of the preceding claims wherein the non-live influenza virus antigen is a split antigen.
A composition for use according to any of the preceding claims, wherein the one or more mono-glycerides are glycerides mono-esterified with carboxylic acids selected from the group consisting of lauric acid (C12), myristic acid (C14), palmitic acid (C16), palmitoleic acid (C16:1), oleic acid (C18:1), linoleic acid (C18:2), stearic acid, hexanoic acid, caprylic acid, decanoic acid (capric acid), arachidic acid, behenic acid, lignoceric acid, alpha-linolenic acid, stearidonic acid, eicosapentaenoic acid, docosahexaenoic acid, gamma-linolenic acid, dihomo-gamma-linolenic acid, arachidonic acid, erucic acid, nervonic acid.
A composition for use according to any of the preceding claims, wherein the one or more mono-glycerides are glycerides mono-esterified with carboxylic acids selected from the group consisting of from palmitoleic acid (C16:1), oleic acid (C18:1) and linoleic acid (C18:2).
A composition for use according to any of the preceding claims, wherein the one or more mono-glyceride is glyceride mono-esterified with oleic acid (glyceryl oleate).
A composition for use according to any of the preceding claims, wherein the one or more carboxylic acids are selected from the group consisting of lauric acid, myristic acid, palmitic acid, palmitoleic acid, oleic acid, linoleic acid stearic acid, hexanoic acid, caprylic acid, decanoic acid (capric acid), arachidic acid, behenic acid, lignoceric acid, alpha-linolenic acid, stearidonic acid, eicosapentaenoic acid, docosahexaenoic acid, gamma-linolenic acid, dihomo-gamma-linolenic acid, arachidonic acid, erucic acid and nervonic acid.
A composition for use according to any of the preceding claims wherein the one or more carboxylic acids are selected from the group consisting of oleic acid and lauric acid.
A composition for use according to any of the preceding claims, wherein the carboxylic acid is oleic acid.
A composition according to any of the preceding claims, wherein the adjuvant comprises glyceryl oleate, oleic acid and an aqeuous medium.
A composition for use according to any of the preceding claims, wherein the vaccine composition comprises monoglycerides in an amount in the range of about 0.1 g to about 5.0 g per 100 mL, or in the range of about 0.1 g about 2.0 g per 100 ml, or about 0.5 g to about 2.0 g, such as 0.5 g to about 1.5 g per 100 mL of the vaccine composition.
A composition for use according to any of the preceding claims, wherein the vaccine composition comprises carboxylic acids is in an amount in the range of. about from 0.1 g to about 5.0 g per 100 mL, or in the range of about 0.1 g to about 2.0 g per 100 mL or about 0.5 g to about 2.0 g, such as 0.5 g to about 1.5 g per 100 mL of the vaccine composition.
A composition for use according to any of the preceding claims, wherein one or more monoglycerides together with one or more carboxylic acids in an adjuvant mix is at the most 10% w/v, or at the most 5% w/v, or at the most 4% w/v, or at the most 3% w/v, or at the most 2% w/v or at the most 1% w/v of the vaccine.
A composition for use as an intranasally administered vaccine to pediatric immuno-compromised subjects, the composition comprising
- one or more non-live influenza virus antigens, and
- an adjuvant comprising:
- one or more carboxylic acids,
- an aqueous medium, and
- optionally one or more mono-glycerides.
A composition comprising
- i) one or more non-live antigens, and
- ii) an adjuvant comprising:
- one or more carboxylic acids,
- an aqueous medium, and
- optionally one or more mono-glycerides
- for use as an intranasally administered vaccine for use in naive immuno-compromised patients.
A composition, said composition comprising
- i) one or more Streptococcus pneumoniae antigens, and
- ii) an adjuvant comprising:
- one or more carboxylic acids,
- an aqueous medium, and
- optionally one or more mono-glycerides
- for use as an intranasally administered vaccine for use in naive subjects and/or immune-compromised patients for the prevention of infection with Streptococcus pneumoniae or for reducing the severity of symptoms associated with an infection with Streptococcus pneumoniae
Dependencies are inferred from the claim text.