Vaccine formulations comprising saponin-containing adjuvants
AssigneeMerial Limited
InventorsNoel Joseph Francois Detraz, Guillaume Rigaut
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Abstract
The present invention provides for a novel oil-in-water (O/W) emulsion, with increased stability in the presence of bacterial or viral suspensions, especially those concentrated and non-purified (crude extracts) or minimally purified. The emulsion of the present invention can act as vehicle for the delivery of a pharmaceutical composition comprising at least one immunogen and, in particular, an immunogen selected from the group consisting of an inactivated pathogen, an attenuated pathogen, a subunit, a recombinant expression vector, and a plasmid or combinations thereof.
Claims15
A safe and effective stable injectable oil-in-water (O/W) vaccine emulsion, wherein the emulsion is effective for eliciting a protective immunologic response in a porcine vaccinate, comprising:
- (i) at least about 10 μg of antigen/2 mL vaccine dose, wherein the antigen is foot and mouth disease virus (FMDV), dissolved in the aqueous phase of the emulsion;
- (ii) 0.7 to about 1.3 mg/2 mL vaccine dose of a saponin, dissolved in the aqueous phase of the emulsion;
- wherein the saponin consists of an anion-exchange column purified extract of Quillaja saponaria Molina bark enriched for QS-17, QS-18 and QS-21;
- (iii) about 0.37% to about 0.42% w/v (of the emulsion) aluminum hydroxide, dissolved in the aqueous phase of the emulsion;
- (iv) a mineral oil, present in an amount of about 20% to about 40% of the emulsion;
- (v) a non-ionic lipophilic surfactant, present in the amount of 0.1% to about 2.5% w/v of the emulsion, and selected from sorbitan fatty acid monoesters, fatty acid esters of mannide, ethoxylated fatty acid esters of mannide, and combinations thereof;
- (vi) a non-ionic hydrophilic surfactant, present in the amount of 0.1% to about 1.5% w/v of the emulsion, and having a high hydrophilic-lipophilic balance (HLB) value between 13 and 40 selected from ethoxylated fatty acid monoesters of sorbitan, ethoxylated fatty acids, and combinations thereof;
- and
- (vii) a non-ionic hydrophilic surfactant present, in the amount of about 1% to about 8% w/v of the emulsion, and having a low hydrophilic-lipophilic balance (HLB) value between 9 and 13 selected from ethoxylated fatty acid triesters of sorbitan, ethoxylated fatty acid diesters of sorbitan, ethoxylated fatty acid monoesters of sorbitan, ethoxylated fatty acids, ethoxylated castor oil and, combinations thereof;
- wherein the final HLB of the emulsion is from about 9 to about 12;
- and
- wherein the emulsion remains a stable O/W emulsion for at least 24 months;
- and
- wherein the only oil present in the emulsion is the mineral oil.
Dependencies are inferred from the claim text.