Hiv vaccine formulation
AssigneeJanssen Vaccines & Prevention B.V.
InventorsThierry-Thien NGUYEN, Mark BRUNER
Life of this patent
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Abstract
Immunogenic compositions containing a human immunodeficiency virus (HIV) gp140 protein, sorbitol, polysorbate 20, and histidine buffer are described. The described immunogenic compositions are advantageous in that they are stable at refrigerated temperature for extended periods of time, and are compatible with an adjuvant. Also described are methods of using the immunogenic compositions to induce an immune response against an HIV in a subject. The immunogenic compositions can be administered alone, or in combination with one or more additional HIV antigens, or one or more adenovirus vectors encoding the one or more additional HIV antigens.
Claims23
An immunogenic composition comprising, relative to the total volume of the composition:
- a. 0.05 mg/mL to 5 mg/mL of an HIV gp140 protein or of a mixture of at least two HIV gp140 proteins;
- b. 2% to 15% (w/v) sorbitol;
- c. 0.01 to 0.05% (w/v) polysorbate 20;
- and
- d. 5 to 20 mM histidine buffer at a pH of 5.5 to 7.0.
An immunogenic composition comprising, relative to the total volume of the composition,
- a. 0.2 mg/mL or 1 mg/mL of an HIV gp140 protein comprising the amino acid sequence of SEQ ID NO:
- 1 or SEQ ID NO:
- 2 or of a mixture of an HIV gp140 protein comprising the amino acid sequence of SEQ ID NO:
- 1 and an HIV gp140 protein comprising the amino acid sequence of SEQ NO:
- 2;
- b. 5% or 12% (w/v) sorbitol;
- c. 0.02% (w/v) polysorbate 20;
- d. 10 mM histidine buffer at a pH of 6.5;
- and
- e. aluminum phosphate adjuvant.
A method of preparing an immunogenic composition comprising admixing:
- a. 0.05 mg/mL to 5 mg/mL of an HIV gp140 protein or of at least two HIV gp140 proteins;
- b. 2% to 15% (w/v) sorbitol;
- c. 0.01 to 0.05% polysorbate 20;
- and
- d. 5 to 20 mM histidine buffer at a pH of 5.5 to 7.0;
- to thereby obtain the immunogenic composition.
(canceled)
Dependencies are inferred from the claim text.