Compositions, methods and uses for thermally stable human papillomavirus formulations
AssigneeThe Regents of the University of Colorado, a body corporate
InventorsTheodore Randolph, Robert Garcea, Kimberly J. Hassett
Life of this patent
Estimating the term…
Abstract
Embodiments of the present invention provide for novel compositions and methods for making and using a thermally stable human papilloma virus (HPV) formulation or other stabilized multimeric virus formulation. Certain embodiments concern lyophilizing HPV formulations in the presence or absence of adjuvants. Other embodiments concern lypophilizing HPV capsomere vaccines in order to increase stability of an immunogenic composition against HPV infection for storage, delivery and use. In yet other embodiments, a single immunogenic composition can include a thermally stable formulation of multiple virus serotypes.
Claims20
An immunogenic composition comprising:
- a multimeric viral protein complex, wherein at least one viral protein of the multimeric viral protein complex is from a pathogenic virus;
- a glass-forming agent, the glass-forming agent is trehalose, sucrose, hydroxyethyl starch, or a combination thereof;
- one or more volatile salt agents, wherein the one or more volatile buffer salt agents are selected from the group consisting of ammonium acetate, ammonium formate, ammonium carbonate, ammonium bicarbonate, triethylammonium acetate, triethylammonium formate, triethylammonium carbonate, trimethylamine acetate trimethylamine formate, trimethylamine carbonate, pyridinal acetate and pyridinal formate and
- a particulate adjuvant,
- wherein the immunogenic composition is essentially dried and the essentially dried immunogenic composition comprises the multimeric viral protein complex, the glass-forming agent, the one or more volatile salt agents and the particulate adjuvant.
A method of preparing an immunogenic formulation, the method comprising:
- (a) combining one or more particulate adjuvants, a glass-forming agents, the glass-forming agents is trehalose, sucrose, hydroxyethyl starch, or a combination thereof, one or more volatile salts and one or more multimeric protein antigens to create a liquid immunogenic formulation;
- (b) freezing the liquid immunogenic formulation to create a frozen immunogenic formulation;
- and
- (c) lyophilizing the frozen immunogenic formulation to create an essentially dried immunogenic formulation wherein the essentially dried immunogenic compositions comprises the multimeric viral protein complex, the glass-forming agent, the one or more volatile salts and the particulate adjuvant.
An immunogenic composition comprising:
- a multimeric viral protein complex, wherein at least one viral protein of the multimeric viral protein complex is from a pathogenic virus;
- a glass-forming agent of trehalose or sucrose or combination thereof but not mannitol and mannitol does not form part of the immunogenic composition;
- at least one co-immunostimulatory agent;
- a particulate adjuvant;
- and
- one or more volatile salt agents,
- wherein the immunogenic composition is essentially dried and the essentially dried immunogenic composition comprises the multimeric viral protein complex;
- trehalose, sucrose or combination of sucrose and trehalose;
- the at least one co-immunostimulatory agent;
- the one or more volatile salt agents and the particulate adjuvant.
Dependencies are inferred from the claim text.