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Immunogenic substances comprising a polyinosinic acid-polycytidilic acid based adjuvantRelated Patent Categories: Chemistry: Molecular Biology And Microbiology, Micro-organism, Tissue Cell Culture Or Enzyme Using Process To Synthesize A Desired Chemical Compound Or Composition, Preparing Compound Containing Saccharide Radical, N-glycoside, , Nucleotide, Polynucleotide (e.g., Nucleic Acid, Oligonucleotide, Etc.)Immunogenic substances comprising a polyinosinic acid-polycytidilic acid based adjuvant description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070166800, Immunogenic substances comprising a polyinosinic acid-polycytidilic acid based adjuvant. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF INVENTION [0001] The invention generally relates to immunogenic compositions and methods of their use. More specifically the invention relates to an immunogenic composition comprising a polynucleotide adjuvant in combination with one or more antigenic substances to be used to elicit disease specific immune response in a host. BACKGROUND OF INVENTION [0002] The immune system may exhibit both specific and nonspecific immunity. Nonspecific immunity encompasses various cells and mechanisms such as phagocytosis (the engulfing of foreign particles or antigens) by macrophages or granulocytes, and natural killer (NK) cell activity, among others. Nonspecific immunity relies on mechanisms less evolutionarily advanced and does not display the acquired nature of specificity and memory, which are exemplary hallmarks of a specific immune response. The key differences between specific and nonspecific immunity are based upon B and T cell specificity. These cells predominantly acquire their responsiveness after activation with a specific antigen and have mechanisms to display memory in the event of future exposure to that specific antigen. As a result, vaccination (involving specificity and memory) is an effective protocol to protect against harmful pathogens. [0003] Generally, B and T lymphocytes, which display specific receptors on their cell surface for a given antigen, produce specific immunity. The specific immune system may respond to different antigens in two ways: 1) humoral-mediated immunity, which includes B cell stimulation and production of antibodies or immunoglobulins, antigen and helper T cells (Th2), and 2) cell-mediated immunity, which generally involves T cells including cytotoxic T lymphocytes (CTLs), although other cells are also involved in the generation of a CTL response (e.g., antigen presenting cells and Th1 cells). [0004] In the continual pursuit for safer and more effective vaccines, new technologies, including recombinant, purification and synthetic methods, have been used to improve the quality and specificity of antigens used. Purified, sub-unit and synthesized antigens demonstrate increased safety but diminished immunogenicity which has been one driver for the identification of effective adjuvant. Thus an effective adjuvant is increasingly an essential component of modern vaccines. Adjuvants are generally compounds, that when administered with an antigen (either mixed with, or given prior to the administration of the antigen) enhances and/or modifies the immune response to that particular antigen. [0005] Exemplary adjuvants that have been used to enhance an immune response include aluminum compounds (all generally referred to as "Alum"), oil-in-water emulsions (complete Freund's adjuvant (CFA) is an oil-in-water emulsion containing dried, heat-killed Mycobacterium tuberculosis organisms), Saponin (isolated from the bark of Quillaja Saponoria, the adjuvant active component known as Quile A), CpG ODN (synthetic oligodeoxynucleotide containing unmethylated CpG dinucleotides), monophosphoryl lipid A (MPL) derived from the lipopolysaccharide of Salmonella minnesota Re595, Liposomes (usually made up of biodegradable materials such as phospholipids) and biodegradable polymer microspheres (made from a variety of polymers such as, polyphosphazene and polyanhydrides). The adjuvant properties of these compounds have been evaluated with each adjuvant showing advantages and disadvantages. [0006] Polynucleotide complexes have been investigated for their various applications including acting as adjuvants. Double-stranded RNAs (dsRNAs) are very potent biologic modifiers that can exert a profound influence on cells at nanomolar concentrations. The modulating effects of dsRNA include a broad spectrum of actions at the molecular and cellular levels. [0007] At the molecular level, dsRNAs can elicit biological effects such as interferon synthesis, induction of protein kinase, enhancement of histocompatibility antigen and inhibition of metabolism. And at the cellular level, dsRNA can elicit biological effects such as pyrogenicity, mitogenicity, macrophage activation, activation of humoral immunity, activation of cell-mediated immunity and induction of antiviral state. Immunomodulating effects of dsRNAs has been disclosed. U.S. Pat. No. 4,124,702 disclosed that double stranded polynucleotides induced interferon induction in living animal cells. U.S. Pat. No. 3,906,092 disclosed that the antibody response to an adjuvant type vaccine was augmented by incorporation in the vaccine of a polynucleotide or a complex of polynucleotides. Houston et al. established PICLC (polyinosinic acid polycytidylic acid poly-L-lysinecarboxy-methylcellulose complex) as a potent adjuvant by increasing primary antibody response without the aid of an additional adjuvant. [0008] Polyinosinic acid-polycytidylic acid (PIC), one of most studied polynucleotide complexes, was not effective when used in monkeys and humans due to its instability in the body after administration. Thus, PIC has been modified in many ways to overcome one or another deficiency. For example, a complex of polyriboinosinic-polyribocytidylic acid with poly-L-lysine hydrobromide is about 5 to 15 times as resistant to hydrolysis by pancreatic ribonuclease as the parent PIC. [0009] Lin et al. described that an antiviral drug comprising polyinosinic polycytidylic acid, kanamycin and calcium can be used as an adjuvant (Lin, et al., A new immunostimulatory complex (PICKCa) in experimental rabies: antiviral and adjuvant effects, Arch Virol, 131: 307-19, 1993; and Chinese Patent No. 93105862.7). The Chinese Patent No. 93105862.7 provides for the use of the general composition of Poly I:C, kanamycin and calcium (PICKCa) as an adjuvant in a vaccine for human and mammalian application. However, Lin found that that the form of PICKCa originally identified does not provide the optimal efficacy/safety profile for use as an adjuvant and also induces unacceptable adverse side effects under certain conditions. [0010] The present invention provides novel immunogenic compositions that exhibit improved safety and efficacy profiles; and methods of use of such compositions. Subject immunogenic compositions include a polynucleotide adjuvant and an antigen. LITERATURE [0011] The following references may be of interest: [0012] JP 1093540A2; [0013] U.S. Pat. No. 4,124,702 [0014] U.S. Pat. No. 3,692,899 [0015] U.S. Pat. No. 3,906,092 [0016] U.S. Pat. No. 4,389,395 [0017] U.S. Pat. No. 4,349,538 [0018] U.S. Pat. No. 4,024,241 [0019] U.S. Pat. No. 3,952,097 [0020] Houston et al., Infection and Immunity, 14: 318-9, 1976C [0021] Wright and Adler-Moore, Biochemical and Biophysical Research Communications, 131: 949-45, 1985 [0022] Lin, et al., A new immunostimulatory complex (PICKCa) in experimental rabies: antiviral and adjuvant effects, Arch Virol, 131: 307-19, 1993 [0023] Chinese Patent 93105862.7 [0024] Gupta R. K. et al., Adjuvants--a balance between toxicity and adjuvanticity, Vaccine, 11:293-306, 1993 [0025] Arnon, R. (Ed.) Synthetic Vaccines 1:83-92, CRC Press, Inc., Boca Raton, Fla., 1987 [0026] Sela, M., Science 166:1365-1374 (1969) [0027] U.S. Pat. No. 6,008,200 [0028] Ellouz et al., Biochem. & Biophy. Res. Comm., 59:1317, 1974 [0029] U.S. Pat. No. 4,094,971 [0030] U.S. Pat. No. 4,101,536 [0031] U.S. Pat. No. 4,153,684 [0032] U.S. Pat. No. 4,235,771 [0033] U.S. Pat. No. 4,323,559 [0034] U.S. Pat. No. 4,327,085 [0035] U.S. Pat. No. 4,185,089 [0036] U.S. Pat. No. 4,082,736 [0037] U.S. Pat. No. 4,369,178 [0038] U.S. Pat. No. 4,314,998 [0039] U.S. Pat. No. 4,082,735 [0040] U.S. Pat. No. 4,186,194 [0041] U.S. Pat. No. 6,468,558 [0042] New Trends and Developments in Vaccines, edited by Voller et al., University Park Press, Baltimore, Md., USA, 1978 [0043] Klein, J., et al., Immunology (2nd), Blackwell Science Inc., Boston (1997) [0044] Gupa R. K. and Siber G. R., Adjuvants for human vaccines--current status, problems and future prospects, Vaccine, 13 (14): 1263-1276, 1995 [0045] Richard T Kenney et al. Meeting Report--2.sup.nd meeting on novel adjuvants currently in/close to human clinical testing, Vaccine 20 2155-2163, 2002 [0046] Laboratory Techniques in Rabies Edited by F X Meslin, M M Kaplan, H Koprowski 4.sup.th Edition ISBN 92 4 1544 1 [0047] PCT Pat. CN2005/000810 [0048] U.S. application Ser. No. 10/551,847. Filed Sep. 29, 2005. SUMMARY OF THE INVENTION [0049] The present invention relates to novel immunogenic compositions comprising a polynucleotide adjuvant composition together with an immunogenic or antigenic substance, and methods of use in eliciting an immune response. BRIEF DESCRIPTION OF THE DRAWINGS [0050] FIG. 1.1 is a graph showing an immune response to the administration of a PIKA/HBsAg antigen composition. [0051] FIG. 1.2 is a graph showing an immune response to the administration of a PIKA/influenza antigen composition. [0052] FIG. 1.3a is a graph showing an immune response to the administration of a PIKA/HIV antigen composition. [0053] FIG. 1.3b is a graph showing a percentage of CD4 positive cells expressing INF-gamma in response to the administration of a PIKA/HIV antigen composition. [0054] FIG. 1.4a is a graph showing an immune response to the administration of a PIKA/anthrax antigen composition. [0055] FIG. 1.4b is a graph showing a percentage of CD4 positive cells expressing INF-gamma in response to the administration of a PIKA/anthrax antigen composition. [0056] FIG. 1.5a is a graph showing an immune response to the administration of a PIKA/HSV composition. Continue reading about Immunogenic substances comprising a polyinosinic acid-polycytidilic acid based adjuvant... 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