Vaccination using high-density microprojection array patch
AssigneeVaxxas Pty Limited
InventorAngus FORSTER
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Abstract
The present invention relates to microprojection arrays for the delivery of vaccines, in particular the use of polymer high density microprojection arrays for the delivery of vaccines to patients in which the dose of the vaccine delivered may be less than the dose of vaccine delivered by intramuscular injection while providing equal or superior immunogenicity.
Claims15
1-51. (canceled)
A method of stimulating an immune response in a human, comprising the step of intradermally administering to the human an influenza vaccine dose, wherein the dose contains sulphobutyl ether beta cyclodextrin which is coated onto a microprojection array patch (MAP), wherein the MAP comprises a base and a number of solid, non-porous projections having a length of about 250 to 600 μm extending from the base made of a synthetic polymer, wherein the density of the projections is from about 1000 to about 5000 projections/cm2 and the MAP weighs between 0.1 to 0.8 grams, wherein at least one projection comprises an uncoated support section which transitions into end section having a tip which is dry-coated with one or more vaccine antigens, wherein there is a discontinuity between the end section and the support section wherein the discontinuity is located from 80 to 120 μm from the tip of the microprojection, wherein the MAP is administered to the skin at a velocity of between 20 to 26 meters per second, and wherein the influenza vaccine dose is dose-sparing as compared to the administration of the influenza vaccine dose administered intramuscularly.
A method of stimulating an immune response in a human population, comprising the step of administering to the human population vaccine doses, wherein the doses contain sulphobutyl ether beta cyclodextrin which are dry-coated onto a microprojection array patch (MAP) and inserted into the skin of the humans in the population, wherein the MAP comprises a base and a number of solid, non-porous projections having a length of about 250 to 600 μm extending from the base made of a synthetic polymer, wherein the density of the projections is from about 1000 to about 5000 projections/cm2 and the MAP weighs between 0.1 to 0.8 grams, wherein at least one projection comprises an uncoated support section which transitions into end section having a tip which is dry-coated with one or more vaccine antigens, wherein there is a discontinuity between the end section and the support section, wherein the discontinuity is located from 80 to 120 μm from the tip of the microprojection and inserted into the skin of the humans in the population, wherein the MAP is administered to the skin at a velocity of between 20 to 26 meters per second, and wherein the seroconversion rate in the human population is at least 85% as measured at least 8 days after the administration of the vaccine.
A method of stimulating an immune response in a human population, comprising the step of administering to the human population vaccine doses, wherein the doses contain sulphobutyl ether beta cyclodextrin which are dry-coated onto a microprojection array patch (MAP), wherein the MAP comprises a base and a number of solid, non-porous projections having a length of about 250 to 600 μm extending from the base made of a synthetic polymer, wherein the density of the projections is from about 1000 to about 5000 projections/cm2 and the MAP weighs between 0.1 to 0.8 grams, wherein at least one projection comprises an uncoated support section which transitions into end section having a tip which is dry-coated with one or more vaccine antigens, wherein there is a discontinuity between the end section and the support section, wherein the discontinuity is located from 80 to 120 μm from the tip of the microprojection, wherein the MAP is administered to the skin at a velocity of between 20 to 26 meters per second and inserted into the skin of the humans in the population, and wherein the geometric mean titres (GMT) in the human population is at least sixfold greater than the GMT compared to intramuscular injection of the same dose of vaccine as measured at least 8 days after the administration of the vaccine.
Dependencies are inferred from the claim text.