Vaccine compositions containing 3-0 deacylated monophosphoryl lipid A
AssigneeSmithKline Beecham Biologicals s.a.
InventorsPierre Hauser, Pierre Voet, Moncef Slaoui, Nathalie Marie-Josephe Claude Garcon-Johnson, Pierre Desmons
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Abstract
Novel vaccine compositions comprising small particles of 3-O-deacylated monophosphoryl lipid A are provided. In particular the particle size is below 120 nm. Such vaccine compositions have superior immunological properties.
Claims53
A sterile vaccine composition comprising an antigen, 3-O-deacylated monophosphoryl lipid A (3D-MPL) particles, and a suitable carrier, wherein the particles of 3D-MPL are small enough to give a clear aqueous suspension of 3D-MPL.
3-O-deacylated monophosphoryl lipid A of a particle size less than 120 nm.
A clear sterile aqueous suspension of 3-O-deacylated monophosphoryl lipid A (3D-MPL) particles.
A method for preparing a clear aqueous suspension of 3-O-deacylated monophosphoryl lipid A particles comprising suspending the 3-O-deacylated monophosphoryl lipid A (3D-MPL) particles in water and reducing the size of the 3D-MPL particles in the resulting suspension until the suspension is clear.
The method of claim wherein 31 wherein the reduction of the size of the 3-D MPL particles is by sonication.
A method for preparing a vaccine comprising admixing a clear aqueous sterile suspension of 3-O-deacylated monophosphoryl lipid A particles with an antigen.
In a method for the manufacture of an antigen containing a medicament for the prophylaxis or treatment of infection, the improvement which comprises admixing said antigen with 3-O-deacylated monophosphoryl lipid A having a particle size which does not exceed 120 nm.
A vaccine formulation which comprises the interaction product of sterile 3-O-deacylated monophosphoryl lipid A 3D-MPL particles, aluminum hydroxide, and an antigen.
An adjuvant composition comprising an aqueous stable suspension of 3-O-deacylated monophosphoryl lipid A (3D-MPL) particles, the particle size of the 3D-MPL being small enough to be filterable through a 220 nm hydrophilic membrane.
A sterile adjuvant composition comprising a filtered aqueous stable suspension of 3-O-deacylated monophosphoryl lipid A (3D-MPL) particles, the filtration recovery of the particles through a 220 nm hydrophilic membrane being at least 78.5%.
A sterile adjuvant composition comprising an aqueous stable suspension consisting essentially of 3-O-deacylated monophosphoryl lipid A (3D-MPL) particles filtered through a 220 nm hydrophilic membrane.
A sterile vaccine composition comprising an antigen, 3-O-deacylated monophosphoryl lipid A (3D-MPL) particles, and a suitable carrier, the particles of 3D-MPL being the recovery of filtration through a 220 nm hydrophilic membrane.
A sterile vaccine composition comprising an antigen, a pharmaceutically acceptable carrier and 3-O-deacylated monophosphoryl lipid A (3D-MPL) consisting essentially of particles of less than 100 nm size.
Dependencies are inferred from the claim text.