Novavax, Inc.

US Government As Represented by the Secretary of the Army

Nabi

University of Michigan

D Craig Wright

Ali Ibrahim Fattom

Joan Brisker

James R Baker, Jr

Tarek Hamouda

Donald F H Wallach

Paul V Lemley, Jr

Michael M Hayes

Mark A Chambers

Walter W Karakawa

Walter W Karakawa, Deceased

Compositions and methods for enhancing the immunity of a subject or vaccinating a subject against mycobacterial infections are disclosed. The invention provides compositions comprising formalin inactivated cultures of a mycobacterium, such as, and a Novasome&#xae; adjuvant, as well as methods for using such compositions.

Mycobacterial vaccine

The present invention features an adjuvanted vaccine, and methods for preparing an adjuvanted vaccine, preferably for immunizing against influenza, where the adjuvant is a lipid vesicle, and preferably is a nonphospholipid, paucilamellar lipid vesicle. The antigen may be encapsulated in the central cavity of the adjuvant, or mixed in solution with the adjuvant. Moreover, the adjuvant may carry a secondary adjuvant to further improve the immune response.

Vaccines containing paucilsmellar lipid vesicles as immunological adjuvants

Methods and pharmaceutical compositions for inactivating an envelope virus using an oil-in-water emulsion including an oil, a surfactant, and an organic phosphate-based solvent are disclosed. These methods can be used to inactivate a wide variety of envelope viruses, such as HIV.

Solvent detergent emulsions having antiviral activity

Methods for inactivating bacteria including bacterial spores using an oil-in-water emulsion are provided. The oil-in-water emulsion comprises an oil, a surfactant and an organic phosphate-based solvent. These methods can be used to inactivate a wide variety of bacteria such as Bacillus.

Methods of inactivating bacteria including bacterial spores

A process is disclosed for culturing clinical Staphylococcus epidermidis cells that reproducibly enables identification of a limited number of predominant serotypes. Two predominant serotypes common to most clinical cases of S. epidermidis have been identified and are denoted Type I and Type II. A particular polysaccharide surface antigen is associated with each of the Type I and Type II serotypes. The surface antigens can be used to provide active and passive immunization against S. epidermidis infection and to produce a hyperimmune immunoglobulin or antibodies for treatment of S. epidermidis infection.

Type I surface antigen associated with staphylococcus epidermidis

A new method of adjuvanting a variety of materials has been developed. Starburst dendrimers, primarily poly(amidoamine) starburst dendrimers, can be used as an adjuvant for Influenza antigen and similar materials. Mid-Generation dendrimers are preferred and yield high antibody titer levels with reduced antigen dosage.

Adjuvant properties of poly (amidoamine) dendrimers

The present invention concerns an oral preparation useful as an immunizing agent or vaccine against gram negative bacterial infection. This oral preparation can also be used as a treatment for those infected with gam negative bacteria. The preparations can be used against any gram negative bacterial infection, including Escherichia coli, Shigella flexneri 2a, and Salmonella enteriditis.

Oral vaccine against gram negative bacterial infection

A novel formulation having anti-viral and spermicidal properties has been developed. The formulation contains lipid vesicles having an outer bilayer formed of a non-ionic amphiphile, a surfactant such as having spermicidal and/or anti-viral activity, an oil and a sterol. The selection of the components making the vesicle is such that the formulation provides rapid spermicidal or anti-viral activity. The formulation and methods of the invention are particularly useful in the mucous membranes such as the vaginal tract and has been tested against viruses such as HIV and Vaccinia.

Lipid vesicles having a bilayer containing a surfactant with anti-viral

Disclosed is a new class of lipid vesicles, liposoils, which have high oil content, low water content, and protein. The liposoils are made using a combination of a surfactant and either dried egg yolk or dried whole egg as the wall material, oil, and an aqueous diluent. Unlike most lipid vesicles, the liposoils can be made with an aqueous diluent having high salinity; in fact, sea water is a preferred aqueous diluent. Liposoils have particular applicability as a food for marine environments, such as a food source for filter feeders such as oysters. Methods of making the liposoils is also disclosed.

Oil containing lipid vesicles with marine applications

The present invention relates to micellar nanoparticles and methods of their production. Micellar nanoparticles are made by hydrating a mixture of an oil, a stabilizer/surfactant, and an alcoholic initiator with an aqueous solution. These micellar nanoparticles are normally less than 100 nanometers in diameter. The micellar nanoparticles are particularly advantageous in delivering materials such as estradiol topically through the skin because their small size allows easy penetration.

Micellar nanoparticles

Monoclonal antibodies against the A chain of ricin have been found to be ective in protecting mammals from morbidity arising from exposure to ricin toxin. The neutralizing action of the antibodies does not appear to be mediated by complement or by immunoprecipitation. The antibodies of the invention are characterized as of isotype IgG1 having the binding characteristics which include: a) binding specifically to the neutralizing epitope of the ricin A chain and b) providing in vitro protection of at least 95% of EL-4 cells from 100 .eta.g/mL ricin challenge when said antibody is present in the tissue culture at a level of at least 1000 .eta.g/mL.

Monoclonal antibody against ricin A chain

An antibacterial oil-in-water emulsion for inhibiting the growth of Helicobacter pylori is disclosed. The oil-in-water emulsion of the invention comprises droplets of an oily discontinuous phase dispersed in a continuous phase. The oily discontinuous phase contains an oil carrier and a glycerol ester selected from the group consisting of glycerol monooleate and glycerol monostearate. The emulsion can be positively charged, negatively charged or chargeless. In one embodiment, the emulsion is positively charged and further comprises a cationic halogen-containing compound having a C.sub.12 -C.sub.16 chain as a positive charge producing agent. In another embodiment, the emulsion is negatively charged and further comprises an negative charge producing agent having a C.sub.12 -C.sub.22 chain. The disclosed emulsions can be administered to individuals, for example, orally, to treat or prevent Helicobacter pylori infections.

Antibacterial oil-in-water emulsions

An antimicrobial lipid-containing oil-in-water emulsion comprising an agent selected from the group consisting of glycerol monooleate, glycerol trioleate, glycerol monolaurate, and glycerol dilaurate as the primary lipid and a cationic halogen-containing compound having a C.sub.12 -C.sub.16 chain as a positive charge producing agent is disclosed. The antimicrobial emulsion can be used in the form of a pharmaceutical preparation to inhibit the growth of a wide variety of infectious pathogens.

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Gaithersburg, MD, United States of America

D Craig Wright