COMPLEX FOR ENHANCING IMMUNE RESPONSE Russian patent published in 2022 - IPC A61K39/39 A61K31/713 A61K45/06 A61K47/02 A61K47/26 A61P31/04 A61P31/12 A61P35/00 A61P37/04 

FIELD: pharmaceutical industry.

SUBSTANCE: group of inventions relates to the pharmaceutical industry, namely to a product for potentiation of an immune response. A combined product for potentiation of an immune response contains polyinosin-polycytidylic acid (hereinafter – PIC), a cationic stabilizer, and soluble calcium salt in a liquid reaction system. In this case, the cationic stabilizer is grafted copolymer of chitosan oligosaccharide and methoxypolyethylene glycol (hereinafter – COS-g-MPEG), where chitosan oligosaccharide is characterized by a molecular weight of 5 kDa or less; polyinosin-polycytidylic acid is preheated at a temperature from 88 to 90°C for 70 to 120 minutes, a ratio of PIC to COS-g-MPEG in the combined product is from 1:0.8 to 1:6.4. A complex for potentiation of an immune response contains a combined product. Non-therapeutic use of the complex as an immune adjuvant is disclosed. The use of the complex for the production of an antibody is also disclosed. The use of the complex for the production of a vaccine composition is also disclosed. The use of the complex for the production of an adjuvant for the vaccine is disclosed. A vaccine composition contains a complex and at least one antigen. The use of the complex for the regulation of the activity of immune cells is described, where the use is carried out in vivo or in vitro. The use of the complex for the production of drugs for the treatment and/or prevention of tumors is described. The use of the complex for the production of antiviral drugs is also described. The use of the complex for the production of antibacterial drugs is also described. The use of the complex for the production of antifungal drugs is also described. The use of the complex for the production of antiparasitic drugs is described. The use of the complex for the production of drugs stimulating an immune response to an antigen in the body is also described. A pharmaceutical composition for the treatment of cancer and infection contains a complex, where the pharmaceutical composition additionally contains one or more of a drug for immune cell therapy, a drug for antibody therapy, a chemical drug, substance, which contributes to the absorption of immunologically active agents by the mucous membrane or adhesion to the mucous membrane, an immunomodulator, a pathogen antigen, a ligand od a pattern-recognizing receptor, and pharmaceutically acceptable auxiliary substance, where the chemical drug is one or more of drugs selected from a group consisting of an alkylating drug, an antimetabolic drug, an antitumor antibiotic, an antitumor drug of plant origin, a hormonal drug, and another drug; where another drug is selected from a group consisting of L-asparaginase, cisplatin, carboplatin, oxaliplatin, dacarbazine, drugs based on hexamethyl melamine and derivatives of the above-mentioned drugs. A method for the stimulation of an immune response to an antigen in the body in vivo includes the administration to the body of a complex, or a vaccine composition, or a pharmaceutical composition. If the antigen is a viral, bacterial, fungal, or parasitic antigen, the complex, or the vaccine composition, or the pharmaceutical composition is administered at a dose of 1-8 mg/kg, in each administration. Alternatively, it is administered once a day, once every 2 days, once every 3 days, or once every 4 days. If the antigen is a tumor antigen, the complex, or the vaccine composition, or the pharmaceutical composition is administered at a dose of 1-10 mg kg, in each administration, and administered for at least 360 days, at least 180 days, at least 60 days, or at least 30 days. A method for the regulation and potentiation of the activity of immune cells in the body includes the administration to the body of a complex, or a vaccine composition, or a pharmaceutical composition. If the antigen is a viral, bacterial, fungal, or parasitic antigen, the complex, or the vaccine composition, or the pharmaceutical composition is administered at a dose of 1-8 mg/kg, in each administration. Alternatively, it is administered once a day, once every 2 days, once every 3 days, or once every 4 days. If the antigen is a tumor antigen, the complex, or the vaccine composition, or the pharmaceutical composition is administered at a dose of 1-10 mg/kg, in each administration, and administered for at least 360 days, at least 180 days, at least 60 days, or at least 30 days.

EFFECT: product and complex based on it have average viscosity and molecular weight, is convenient for use in pharmaceutical production; have stable chemical properties, practically do not degrade during long-term storage, are safe for use, significantly enhance a nonspecific immune response of the body, and achieve improved antitumor, antiviral and anti-(over)bacterial efficiency.

48 cl, 35 dwg, 3 tbl, 16 ex