Adjuvants for viral vaccines

• US 5,690,942 A
• Filed: 06/02/1995
• Issued: 11/25/1997
• Est. Priority Date: 06/02/1995
• Status: Expired due to Term

• Current Assignee: Zoetis Services LLC (Zoetis Incorporated)
• Original Assignee: American Home Products Corporation (Pfizer Inc.)
• Inventors: Hjorth, Richard N.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): GRASER, JENNIFER E
• Application Number:
  US08/459,602
• Time in Patent Office: 907 Days
• Field of Search: 424/278.1, 424/283.1, 424/209.1, 424/210.1, 424/682, 424/690, 514/78
• US Class Current: 424/283.1
• CPC Class Codes: A61K 2039/55566 Emulsions, e.g. Freund's adjuvant, MF59
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention discloses mammalian vaccine compositions having an effective amount of an adjuvant, the adjuvant comprising squalene or squlane, one or more phospholipids and a surfactant. These compositions also optionally contain an aluminum salt and one or more pharmaceutically acceptable buffers.

Claims

1. A mammalian vaccine composition comprising an inactivated whole or subunit vaccine and an effective amount of an adjuvant, the adjuvant consisting essentially of any one of squalene, squalane, or a mixture thereof, in the amount of from about 1% to about 40% by volume of the total composition, a lecithin in the amount of from about 0.5% to about 4% by volume of the total composition, and a polyoxyethylenesorbitan ester surfactant in the amount of from about 0.1% to about 4.0% of the total composition.

2. The mammalian vaccine composition of claim 1 in which the adjuvant consists essentially of squalene in the amount of from about 5% to about 20% by volume of the total composition, a lecithin in the amount of from about 0.7% to about 2% by volume of the total composition, and a polyoxyethylenesorbitan ester surfactant in the amount of from about 0.15% to about 1.6% of the total composition.

3. The mammalian vaccine composition of claim 1 in which the adjuvant consists essentially of squalene in the amount of from about 8% to about 12% by volume of the total composition, a lecithin in the amount of from about 0.8% to about 1.2% by volume of the total composition, and a polyoxyethylenesorbitan ester surfactant in the amount of from about 0.18% to about 0.22% of the total composition.

4. The mammalian vaccine composition of claim 1 in which the adjuvant further contains a pharmaceutically acceptable pH buffer.

5. The mammalian vaccine of claim 4 in which the pharmaceutically acceptable pH buffer is PBS.

6. The mammalian vaccine composition of claim 1 in which the adjuvant further contains an aluminum salt at a weight/volume concentration of from about 0.1% to about 2.0%.

7. The mammalian vaccine composition of claim 6 in which the aluminum salt is aluminum hydroxide.

8. The mammalian vaccine composition of claim 1 in which the vaccine is a subunit influenza A vaccine.

9. A mammalian vaccine composition comprising an inactivated whole or subunit vaccine and an effective amount of an adjuvant in a pharmaceutically acceptable buffer, the adjuvant consisting essentially of squalene in the amount of from about 8% to about 12% by volume of the total composition, a lecithin in the amount of from about 0.8% to about 1.2% by volume of the total composition, and a polyoxyethylenesorbitan ester surfactant in the amount of from about 0.18% to about 0.22% of the total composition, the composition further containing from about 0.1% to about 2.0% of an aluminum salt.

10. The mammalian vaccine composition of claim 9 in which the aluminum salt is aluminum hydroxide.