Mycobacterium antigenic composition
AssigneeGlaxosmithkline Biologicals SA
InventorsStéphane André Georges Godart, Amina Laanan, Dominique Ingrid Lemoine
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Abstract
Immunogenic compositions comprising an M72 related antigen, wherein the conductivity of the composition is 13 mS/cm or lower, or the concentration of salts of the composition is 130 mM or lower, and their use in medicine, are provided.
Claims33
An immunogenic composition comprising an M72 related antigen, wherein:
- (i) the conductivity of the composition is 13 mS/cm or lower;
- and/or
- (ii) the concentration of salts in said composition is 130 mM or lower;
- and/or
- (iii) the concentration of sodium chloride in said composition is 130 mM or lower.
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A method for the prophylaxis, treatment or amelioration of infection by mycobacteria, such as infection by Mycobacterium tuberculosis, comprising the administration of a safe and effective amount of an immunogenic composition according to claim 31.
A process for the making an immunogenic composition according to claim 31, comprising the steps:
- a) lyophilising an M72 related antigen;
- and
- b) reconstituting the lyophilised M72 related antigen of step a) with an aqueous solution wherein:
- (i) the conductivity of the solution is 13 mS/cm or lower;
- and/or
- (ii) the concentration of salts in said solution is 130 mM or lower;
- and/or
- (iii) the concentration of sodium chloride in said solution is 130 mM or lower.
A method for the manufacture of a stable immunogenic composition according to claim 31, comprising the steps:
- a) lyophilising an M72 related antigen;
- and
- b) reconstituting the lyophilised M72 related antigen of step a) with an aqueous solution wherein:
- (i) the conductivity of the solution is 13 mS/cm or lower;
- and/or
- (ii) the concentration of salts in said solution is 130 mM or lower;
- and/or
- (iii) the concentration of sodium chloride in said solution is 130 mM or lower;
- wherein at least 80% of the antigenicity of the immunogenic composition remains after storage at 25° C. for a period of 24 hours.
A kit comprising:
- a) a lyophilised M72 related antigen;
- and
- b) an aqueous solution wherein:
- (i) the conductivity of the solution is 13 mS/cm or lower;
- and/or
- (ii) the concentration of salts in said solution is 130 mM or lower;
- and/or
- (iii) the concentration of sodium chloride in said solution is 130 mM or lower.
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Dependencies are inferred from the claim text.