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 Adjuvant and vaccine compositions containing monophosphoryl lipid A

Details
Inventors: LaPosta, Vincent James; Eldridge, John Hayward;
Assignee: American Cyanamid Company (Madison, NJ)
Primary Examiner: Bui; Phuong T.
Assistant Examiner:
Attorney, Agent or Firm: Moram; Daniel B., Szatkowski; Thomas S.

The invention pertains to adjuvant and vaccine compositions of monophosphoryl lipid A, sugar and optionally an amine based surfactant, which when frozen and thawed or lyophilized and reconstituted reform a colloidal suspension having a light transmission of greater than or equal to 88% as measured spectrophotometrically.

DETAILED DESCRIPTION What is claimed: 1.
A lyophilized composition comprising 0.
2% up to 5% by weight 3-O-desacyl-4'-monophosphoryl lipid A, at least 70% by weight of sugar and 0% to about 30% by weight of an optionally added amine based surfactant wherein when 10 to 210 mg of said lyophilized composition is reconstituted per ml of an aqueous diluent, an aqueous colloidal suspension having a light transmission of greater than or equal to 88% as measured spectrophotometrically is formed without sonication 2.
The lyophilized composition according to claim 1 comprising 0.
2% up to 4% by weight 3-O-desacyl-4'-monophosphoryl lipid A, sugar from about 75% to about 99.
99% by weight and amine based surfactant from 0% to about 22% by weight.
3.
The lyophilized composition according to claim 1 wherein the sugar comprises dextrose, mannose, galactose, fructose, sucrose, lactose, isomaltose, maltose or trehalose.
4.
The lyophilized composition according to claim 1 wherein the sugar is sucrose or dextrose.
5.
The lyophilized composition according to claim 1 wherein the amine based surfactant is triethylamine or triethanolamine.
6.
The lyophilized composition according to claim 1 further comprising an amount of an antigen or antigens effective to evoke an immune response to said antigen or antigens.
7.
A vaccine composition comprising an amount of the lyophilized composition of claim 1 to provide an amount of 3-O-desacyl-4'-monophosphoryl lipid A, effective to enhance the immune response of an antigen or antigens and an amount of said effective to evoke an immune response to said antigen or antigens.
8.
The vaccine composition according to claim 7 wherein the antigen or antigens are from or produced by a bacterium, a virus, a parasite, a cancer cell or an allergen.
9.
The vaccine composition according to claim 7 wherein the antigen is a Chlamydia, Nontypeable Haemophilus influenzae, Helicobacter pylori, Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Salmonella typhi, Streptococcus pneumoniae, Group A Streptococci, Group B Streptococcus, Human Papilloma virus, Influenza virus, Measles, Parainfluenza, Respiratory Syncytial Virus, Rotavirus, or Norwalk Virus antigen



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