Vaccine patents with possible peanut products in them

WO 1993021325 19931028

WILD-TYPE MEASLES VIRUS GLYCOPROTEINS: VACCINE AND DETECTION METHOD THEREFOR
Background of the Invention
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It is yet another object of the invention to provide a measles virus consensus hemagglutinin polypeptide in substantially pure form that possesses an amino acid sequence described by a consensus hemagglutinin formula herein.

It is a further another object of the invention to provide a measles virus consensus fusion polypeptide in substantially pure form which contains six amino acid substitutions, relative to the Moraten strain fusion protein, which are shared among at least two wild-types of measles virus….

A vaccine according to the present invention further comprises an adjuvant in order to increase the immunogenicity of the vaccine preparation. The adjuvant can be selected, for example, from Freund’s complete or incomplete adjuvant, aluminum hydroxide, a saponin, a muramyl dipeptide, an iscorn, a vegetable oil (li e peanut oil) or a mineral oil, such as silicone oil.

US Patent 5753234 - Single-shot vaccine formulation

Exemplary injection media which can be used in the present invention include a buffer with or without dispersing agents and/or preservatives, an edible oil, mineral oil, cod liver oil, squalene, squalane, mono-, di- or triglyceride and a mixture thereof; said edible oil being corn oil, sesame oil, olive oil, soybean oil, safflower oil, cotton seed oil, peanut oil or a mixture thereof.

US Patent 6720001 - Emulsion compositions for polyfunctional active ingredients
1. A stabilized pharmaceutical oil-in-water emulsion for delivery of a polyfunctional drug, wherein the emulsion has a mean particle diameter of less than about 5 μm and consists essentially of:

(a) a therapeutically effective amount of a polyfunctional drug selected from the group consisting of analgesics, anti-inflammatory agents, anthelmintics, antiarrhythimic agents, anti-asthma agents, anti-bacterial agents, anti-viral agents, anti-coagulants, anti-depressants, anti-diabetic agents, anti-epileptic agents, anti-fungal agents, anti-gout agents, anti-hypertensive agents, anti-malarials, anti-migraine agents, anti-muscarinic agents, anti-neoplostic agents, immunosuppressants, anti-protozoal agents, anti-thyroid agents, anti-tussives, anxiolytics, sedatives, hypnotics, neuroleptic agents, β-blockers, cardiac inotropic agents, corticosteroids, diuretics, anti-parkinsonism agents, gastrointestinal agents, histamine receptor antagonists, keratolytics, lipid regulating agents, muscle relaxants, anti-anginal agents, sex hormones, stimulants, cytokines, peptidomimetics, proteins, peptides, toxoids, antibodies, vaccines, nucleosides, nucleotides, nucleic acids, DNA, RNA, oligonucleotides, oligodeoxynucleotides, and combinations thereof;

(b) an aqueous phase;

(c) an oil phase consisting essentially of…
8. The pharmaceutical emulsion of claim 1, wherein the oil phase further comprises almond oil; babassu oil; borage oil; black currant seed oil; canola oil; castor oil; coconut oil; corn oil; cottonseed oil; emu oil; evening primrose oil; flax seed oil; grapeseed oil; groundnut oil; mustard seed oil; olive oil; palm oil; palm kernel oil; peanut oil; rapeseed oil; safflower oil; sesame oil; shark liver oil; soybean oil; sunflower oil; hydrogenated castor oil; hydrogenated coconut oil; hydrogenated palm oil; hydrogenated soybean oil; hydrogenated vegetable oil; a mixture of hydrogenated cottonseed oil and hydrogenated castor oil; partially hydrogenated soybean oil; a mixture of partially hydrogenated soybean oil and partially hydrogenated cottonseed oil; glyceryl trioleate; glyceryl trilinoleate; glyceryl trilinolenate; a Ω3 polyunsaturated fatty acid triglyceride containing oil; or a mixture thereof.

9. The pharmaceutical composition of claim 1, wherein the oil phase further comprises coconut oil; corn oil; olive oil; palm oil; peanut oil; safflower oil; sesame oil; soybean oil; hydrogenated castor oil; hydrogenated coconut oil; partially hydrogenated soybean oil; glyceryl trioleate; glyceryl trilinoleate; glyceryl trilinolenate; a Ω3 polyunsaturated fatty acid triglyceride containing oil; or a mixture thereof.

10. The pharmaceutical composition of claim 1, wherein the oil phase further comprises corn oil; olive oil; palm oil; peanut oil; safflower oil; sesame oil; soybean oil; hydrogenated castor oil; partially hydrogenated soybean oil; glyceryl trioleate; glyceryl trilinoleate; a Ω3 polyunsaturated fatty acid triglyceride containing oil; or a mixture thereof.

Patent title: Sustained Release Vaccine Composition
88. A non-liquid vaccine composition according to claim 87, including a component active against one or more disease pathogens selected from the group consisting of Adenovirus, AIDS, Anthrax, BCG, Chlamydia, Cholera, Circovirus, Classical swine fever, Coronavirus, Diphtheria-Tetanus, Distemper virus, DTaP, DTP, E coli, Eimeria (coccidosis), Encephalitis, Feline immunodeficiency virus, Feline leukemia virus, Foot and mouth disease, Hemophilus, Hepatitis A, B,C,D,E,F, Hepatitis B/Hib, Herpes virus, Hib, Influenza, Japanese Encephalitis, Lyme disease, Measles, Measles-Rubella, Meningococcal, MMR, Mumps, Mycoplasma, Para influenza virus, Parvovirus, Pasteurella, Pertussis, Pestivirus, Plague, Pneumococcal, Polio (IPV), Polio (OPV), Pseudorabies, Rabies, Respiratory syncitial virus, Rhinotracheiitis, Rotavirus, Rubella, Salmonella, SARS, Tetanus, Typhoid, Varicella, Viral diarrhoea virus, Yellow Fever. …

[0049]In certain embodiments, the vaccine composition may include other adjuvants, including adjuvants in liquid form. Such other adjuvants that may be used include squalene and squalene, Adjuvant 65 (containing peanut oil, mannide monooleate and aluminium monostearate), surfactants such as ...

NOVEL PEANUT SKIN EXTRACT AS A VACCINE ADJUVANT
Abstract not available for EP1742656
Abstract of corresponding document: WO2005089262
The present invention relates to a novel adjuvant and/or immunomodulator isolated from peanut skin extract, which may be useful in the preparation of immunogenic compositions and vaccines. The present invention also provides for a method of stimulating acquisition of protective immunity by administering peanut skin extract prior to vaccination.

TUBERCULOSIS VACCINE FORMULATION COMPRISING MONOGLYCERIDES OR FATTY ACIDS AS ADJUVANT
…The TB vaccine composition according to the invention may further comprise pharmaceutical excipients selected from the group consisting of biocompatible oils, such as rape seed oil, sunflower oil, peanut oil, cotton seed oil, jojoba oil, squalan or squalene, physiological saline solution, preservatives and osmotic pressure controlling agents, carrier gases, pH-controlling agents, organic solvents, hydrophobic agents, enzyme inhibitors, water absorbing polymers, surfactants, absorption promoters, and anti-oxidative agents….

Use of GM-CSF as a vaccine adjuvant
…To obtain a stronger humoral and/or cellular response, it is common to administer a vaccine in a formulation containing an adjuvant. An adjuvant is a substance that enhances, nonspecifically, the immune response to an antigen, or which causes an individual to respond to an antigen who would otherwise without the adjuvant not respond to the antigen. An adjuvant is usually administered with an antigen, but may also be given before or after antigen administration. Suitable adjuvants for the vaccination of mammals include but are not limited to Adjuvant 65 (containing peanut oil, mannide monooleate and aluminum monostearate); Freund’s complete or incomplete adjuvant; mineral gels such as aluminum hydroxide, aluminum phosphate and alum; surfactants such as hexadecylamine, octadecylamine, lysolecithin, dimethyldioctadecyl-ammonium bromide, N,N-dioctadecyl-N’,N’-bis(2-hydroxymethyl) propanediamine, methoxyhexadecylglycerol and pluronic polyols; polyanions such as pyran, dextran sulfate, poly IC, polyacrylic acid and carbopol; peptides such as muramyl dipeptide, dimethylglycine and tuftsin; and oil emulsions. The antigens could also be administered following incorporation into liposomes or other microcarriers….

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Formulation 2 INGREDIENTS
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Lyopilized GM-CSF 10-1000 mcg
Water-for-injection for reconstitution
0.2 ml
Dioctyl Sodium Sulfosuccinate
1 mg
Peanut oil for emulsion
2 ml
Peanut oil for gel 2 ml
Aluminum monostearate 50 mg

To prepare the sustained release preparation of GM-CSF according to Formulation 2, the aluminum monostearate is mixed into the peanut oil for the gel and heat elevated to form the gel according to known methods.

The dioctyl sodium sulfosuccinate is dissolved into the Water for Injection. The lyophilized GM-CSF is reconstituted with the dioctyl sodium sulfosuccinate solution, the resultant solution is transfered into the peanut oil for emulsion and mixed by vortexing. The resultant emulsion is then mixed into the previously prepared gelled peanut oil and mixed by vortexing.

…To obtain a stronger humoral and/or cellular response, it is common to administer a vaccine in a formulation containing an adjuvant. An adjuvant is a substance that enhances, nonspecifically, the immune response to an antigen, or which causes an individual to respond to an antigen who would otherwise without the adjuvant not respond to the antigen. An adjuvant is usually administered with an antigen, but may also be given before or after antigen administration. Suitable adjuvants for the vaccination of mammals include but are not limited to Adjuvant 65 (containing peanut oil, mannide monooleate and aluminum monostearate); Freund’s complete or incomplete adjuvant; mineral gels such as aluminum hydroxide, aluminum phosphate and alum; surfactants such as hexadecylamine, octadecylamine, lysolecithin, dimethyldioctadecyl-ammonium bromide, N,N-dioctadecyl-N’,N’-bis(2-hydroxymethyl) propanediamine, methoxyhexadecylglycerol and pluronic polyols; polyanions such as pyran, dextran sulfate, poly IC, polyacrylic acid and carbopol; peptides such as muramyl dipeptide, dimethylglycine and tuftsin; and oil emulsions. The antigens could also be administered following incorporation into liposomes or other microcarriers….

Vaccine formulation
DETAILED DESCRIPTION OF THE INVENTION

The vaccine formulation of the invention employs a saponin and an oil as an adjuvant. It is a parenterally administerable mono- or polyvalent vaccine in which the antigen is any antigen or antigenic component for stimulating a desired immune response. Such vaccine can be, for example, a vaccine for protecting a mammal against infection, or against development of a disease state resulting from infection, by a pathogenic or opportunistic bacteria, virus, parasite or other invasive microbe or organism. Such vaccine can also be, for example, a hormone such as leutenizing hormone. In the former case, the antigen can be one or more modified or inactivated bacteria, viruses, parasites or other microbes or organisms or one or more subunits thereof or derivatives of such subunits.

The vaccine is formulated to comprise a vaccinal amount, that is, an effective, non-toxic amount of each antigen per dose in accordance with standard procedures for vaccine preparation employing an O/W or W/O emulsion. Typically, this comprises adding an immunostimulating antigen and a saponin to the oil or water phase of an oil and water emulsion prior to combining the oil and water. Usually, the antigen and saponin are added to the water. A saponin is typically added to the aqueous phase in an amount of 15 to 5000 micrograms, preferably 25 to 1000 micrograms, per dose. Any of the saponins or saponin derivatives can be used. See, e.g., Charlier et al., Arch. Exp. Vet.-Med. 27: 783 (1973) and Bonati, U.S. Pat. No. 4,101,652. Preferably, such saponin has lipophilic and hydrophilic regions and therefore can function as a surfactant and emulsifier. Quil A is the preferred saponin. Quil A forms micelles in aqueous solutions at concentrations as low as 0.03% and forms complexes with a wide range of antigens. It is publicly available from a variety of sources including commercial vendors, such as Superfos (Copenhagen, Denmark).

The oil phase comprises one or more parenterally tolerated oils. These include vegetable oil such as soy bean oil and peanut oil, mineral oils, such as Drakeol 6VR, animal oils such as squalene, and intermediate length (C12 to C20) alkanes, optionally substituted, such as hexadecane. See, for example, Murray et al., Ann. Allergy 30: 146 (1972). The amount of oil is up to 95% by volume. In O/W emulsions, the amount of oil is preferably 0.2 to 20%, more preferably 0.5 to 10% and in W/O emulsions the amount of oil is preferably 40 to 90%, more preferably 50 to 70%.

Infectious DNA as a vaccine against west nile and other flaviviruses
…The term “carrier” refers to a diluent, adjuvant, excipient, or vehicle with which the attenuated virus or infectious DNA is administered. Such pharmaceutical carriers can be sterile liquids, such as water and oils, including those of petroleum, animal, vegetable or synthetic origin, such as peanut oil, soybean oil, mineral oil, sesame oil and the like. Suitable pharmaceutical excipients include starch, glucose, lactose, sucrose, gelatin, malt, rice, flour, chalk, silica gel, sodium stearate, glycerol monostearate, talc, sodium chloride, dried skim milk, glycerol, propylene, glycol, water, ethanol and the like. The composition, if desired, can also contain minor amounts of wetting or emulsifying agents, or pH buffering agents. These compositions can take the form of solutions, suspensions, emulsion, tablets, pills, capsules, powders, sustained-release formulations and the like. The composition can be formulated as a suppository, with traditional binders and carriers such as triglycerides. Oral formulation can include standard carriers such as pharmaceutical grades of mannitol, lactose, starch, magnesium stearate, sodium saccharine, cellulose, magnesium carbonate, etc. Examples of suitable pharmaceutical carriers are described in “Remington’s Pharmaceutical Sciences” by E. W. Martin….

Vaccine for enhanced production of IgA antibodies
…Any pharmaceutically acceptable carrier can be employed for the multivalent antigen receptor crosslinker, CD40 ligand, TGF-β, IL-4, and either IL-5 or IL-2. Carriers can be sterile liquids, such as water, oils, including petroleum oil, animal oil, vegetable oil, peanut oil, soybean oil, mineral oil, sesame oil, and the like. With intravenous administration, water is a preferred carrier. Saline solutions, aqueous dextrose, and glycerol solutions can also be employed as liquid carriers, particularly for injectable solutions. Suitable pharmaceutical carriers are described in Remington’s Pharmaceutical Sciences, 18th Edition (A. Gennaro, ed., Mack Pub., Easton, Pa., 1990), incorporated by reference….

Vaccine compositions containing liposomes
…Sources for vegetable oils include nuts, seeds and grains. Peanut oil, soybean oil, coconut oil, and olive oil, the most commonly available, exemplify the nut oils. Seed oils include safflower oil, cottonseed oil, sunflower seed oil, sesame seed oil and the like. In the grain group, corn oil is the most readily available, but the oil of other cereal grains such as wheat, oats, rye, rice, teff, triticale and the like may also be used….

Vaccine formulation
…The vaccine formulation according to the invention may further comprise pharmaceutical excipients selected from the group consisting of biocompatible oils, such as such as rape seed oil, sunflower oil, peanut oil, cotton seed oil, jojoba oil, squalan or squalene, physiological saline solution, preservatives and osmotic pressure controlling agents, carrier gases, pH-controlling agents, organic solvents, hydrophobic agents, enzyme inhibitors, water absorbing polymers, surfactants, absorption promoters, and anti-oxidative agents….

Influenza immunogen and vaccine

…Vaccines or inocula are typically prepared from a recovered recombinant HBc chimer immunogen particles by dispersing the particles in a physiologically tolerable (acceptable) diluent vehicle such as water, saline phosphate-buffered saline (PBS), acetate-buffered saline (ABS), Ringer’s solution or the like to form an aqueous composition. The diluent vehicle can also include oleaginous materials such as peanut oil, squalane or squalene as is discussed hereinafter….

…Another particularly preferred adjuvant for use with an immunogen of the present invention is an emulsion. A contemplated emulsion can be an oil-in-water emulsion or a water-in-oil emulsion. In addition to the immunogenic chimer protein particles, such emulsions comprise an oil phase of squalene, squalane, peanut oil or the like as are well known, and a dispersing agent. Non-ionic dispersing agents are preferred and such materials include mono- and di-C12-C24-fatty acid esters of sorbitan and mannide such as sorbitan mono-stearate, sorbitan mono-oleate and mannide mono-oleate. An immunogen-containing emulsion is administered as an emulsion….

West nile vaccine
Suitable adjuvants can include immunostimulating oils such as certain metabolizable oils. Metabolizable oils suitable for use in the composition of the invention include oil emulsions, e.g., SP oil (hereinafter described), Emulsigen (MPV Laboratories, Ralston, NZ), Montanide