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Last Updated: April 23, 2024

Claims for Patent: 8,088,395

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Summary for Patent: 8,088,395

Title:	Phytol derived immunoadjuvants and their use in vaccine formulations
Abstract:	This invention relates to a novel immunoadjuvant, an adjuvant component, and vaccines containing the adjuvant component. The adjuvant includes phytol or a phytol derivative. The adjuvant component, when combined with a soluble or particulate antigen, provides a vaccine with an enhanced ability to induce both humoral and cytotoxic immune responses while displaying reduced toxicity and/or adverse side effects over vaccines that include the antigen but without the benefit of this adjuvant component.
Inventor(s):	Ghosh; Swapan K. (Terre Haute, IN)
Assignee:	Indiana State University (Terre Haute, IN)
Application Number:	11/295,131
Patent Claims:	1. An immunogenic composition comprising: a vaccine antigen; an adjuvant component comprising phytol, phytanol, or a phytol derivative wherein the phytol derivative is of the following formula: ##STR00005## wherein R.sup.1 is selected from the group of chemical moieties, ions, or radicals consisting of: Br.sup.-, Cl.sup.-, I.sup.-, --NH.sub.2, --NO.sub.2, OH, PO.sub.4.sup.=, HPO.sub.4.sup.-, NHR.sup.2, OC(O)R.sup.2, OR.sup.2, wherein R.sup.2 is a hydrocarbyl having 1 to 10 carbon atoms or a carbohydrate; wherein the vaccine antigen is homogenously dispersed in the adjuvant component; and optionally a carrier. 2. The composition of claim 1 wherein the adjuvant component comprises phytol. 3. The composition of claim 1 wherein the adjuvant component comprises phytanol. 4. The composition of claim 1 wherein the adjuvant component comprises a phytol derivative selected from the group consisting of: phytanol; 3,7,11,15-tetramethyl-1-hexadecanyl acetate; 1-chloro-3,7,11,15-tetramethyl hexadecane; 1-iodo-3,7,11,15-tetramethyl hexadecane; 1-amino-3,7,11,15-tetramethyl hexadecane; 1-methyl amino-3,7,11,15-tetramethyl hexadecane; stereoisomers and mixtures thereof. 5. The composition of claim 1 wherein the antigen includes a T-independent antigen. 6. The composition of claim 5 wherein the antigen is selected from the group consisting of polysaccharides, pneumococcus polysaccharides, bacterial lipopolysaccharides, synthetic lipopolysaccharides, and hapten-polysaccharide conjugates. 7. The composition of claim 1 wherein the vaccine antigen comprises a T-dependent antigen. 8. The composition of claim 7 wherein the vaccine antigen is selected from the group consisting of: proteins, peptides, lipoproteins, glycoproteins, gangliosides, cerebrosides, nucleoproteins, eukaryotic cellular isolates, and prokaryotic cellular isolates. 9. The composition of claim 1 wherein the carrier is sterile water at pH 7.0. 10. The composition of claim 1 wherein the carrier comprises physiological buffers that include carbonates, bicarbonates, phosphates. 11. The composition of claim 1 wherein the composition is an oil-in-water emulsion. 12. The composition of claim 11 further comprising a surfactant or emulsifier. 13. The composition of claim 12 wherein the emulsifier is selected from the group consisting of: phospholipids, lysophosphoglycerides, spingomyelin, phosphatidyl choline, phosphatidyl ethanolamine, phosphatidyl inositol and mixtures thereof. 14. The composition of claim 1 wherein the adjuvant component and the vaccine antigen are present at a weight ratio of between about 1:4 to about 1:1. 15. The composition of claim 1 wherein the composition is in a unit dosage form. 16. The composition of claim 1 wherein R.sup.1 is Br.sup.-, Cl.sup.-; I.sup.-; --NH.sub.2, --NO.sub.2, OH, PO.sub.4.sup.=, HPO.sub.4.sup.-, NHR.sup.2, OC(O)R.sup.2, OR.sup.2, wherein R.sup.2 is a hydrocarbyl having 1 to 10 carbon atoms or a carbohydrate. 17. The composition of claim 1 wherein R.sup.1 is Cl.sup.-. 18. The composition of claim 1 wherein R.sup.1 is I.sup.-. 19. The composition of claim 1 wherein R.sup.1 is --NH.sub.2. 20. The composition of claim 1 wherein R.sup.1 is OC(O)R.sup.2 or OR.sup.2, wherein R.sup.2 is mannitol.

Details for Patent 8,088,395

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006	⤷ Try a Trial	2024-01-21
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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