Abstract: Codon optimized polynucleotides for optimal expression of recombinant proteins in eukaryotic cells are provided. The codon optimized polynucleotides encode a viral capsid protein that self assembles into a virus-like particle. The virus-like particle is expressed extracellularly and exhibits conformational antigenic epitopes capable of raising neutralizing antibodies. Pharmaceutical compositions, vaccines, and diagnostic test kits containing the gene products of the codon-optimized polynucleotides are also provided.

Abstract: Methods for isolation and purification or recombinant gene products are disclosed. In particular, methods for isolation and purification of extracellular and intracellular viral gene products, including virus-like particles, are disclosed herein.

Abstract: An insect cell line capable of growth in serum-free media and secretion of high levels of recombinant proteins, including virus-like particles, upon infection with recombinant baculoviruses, is provided. Methods involving clonal selection processes, serum-weaning and recombinant protein secretion selection are used to create the insect lines of the invention. This cell line supports replication of baculoviruses, serves as host substrate for baculovirus plaque assays, provides a source of insect proteins, acts as a depot for cell transfection to produce recombinant baculoviruses, and express viral recombinant proteins. Extracellular and intracellular viral recombinant proteins and virus-like particles expressed from this cell line are useful as pharmaceutical compositions, vaccines, or diagnostic reagents.

Abstract: The invention relates to the expression of open reading frame 2 (ORF-2) proteins of a strain of hepatitis E virus from Pakistan (SAR-55) in a eukaryotic expression system. The expressed proteins can serve as an antigen in diagnostic immunoassays and/or as an immunogen or vaccine to protect against infection by hepatitis E.

Abstract: 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.

Abstract: A method for treating a tumor is provided, which comprises the steps of preliminarily immunizing a patient in need of antitumor treatment with a toxin or toxin surrogate vaccine in an amount which is effective to generate an immune response to the toxin in the patient, thereby providing systemic protection from the toxin to the patient, and subsequently administering the toxin to the patient in an amount which is effective to kill tumor cells. The toxin may be any suitable toxin, for example ricin, abrin, gelonin or diphtheria.

Abstract: The invention relates to the expression of open reading frame 2 (ORF-2) proteins of a strain of hepatitis E virus from Pakistan (SAR-55) in a eukaryotic expression system. The expressed proteins can serve as an antigen in diagnostic immunoassays and/or as an immunogen or vaccine to protect against infection by hepatitis E.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A method for treating a tumor is provided, which comprises the steps of preliminarily immunizing a patient in need of antitumor treatment with a toxin or toxin surrogate vaccine in an amount which is effective to generate an immune response to the toxin in the patient, thereby providing systemic protection from the toxin to the patient, and subsequently administering the toxin to the patient in an amount which is effective to kill tumor cells. The toxin may be any suitable toxin, for example ricin, abrin, gelonin or diphtheria.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.