STABLE VACCINE PREPARATION FROM VIRUS-LIKE PARTICLES OF HUMAN PAPILLOMAVIRUS Russian patent published in 2024 - IPC A61K39/12 A61K39/295 A61K39/39 A61P15/00 

FIELD: biotechnology; medicine.

SUBSTANCE: invention relates to medical biotechnology. Presented is a stable preparation of a polyvalent vaccine of human papillomavirus virus-like particles for preventing diseases or infections associated with HPV. Stable preparation contains: (a) a plurality of virus-like particles of human papillomavirus, where the concentration of virus-like particles of papillomavirus of any particular type included in the polyvalent virus-like particles of papillomavirus is from 40 mcg/ml to 120 mcg/ml; (b) an aluminium phosphate adjuvant; (c) a histidine buffer with concentration of 10 mM to 26 mM; (d) an osmotic pressure regulator, which is sodium chloride with concentration of 150 mM to 320 mM; and, optionally, (e) surfactant, which is polysorbate 80 with concentration of not more than 0.3 mg/ml, wherein said virus-like particles of human papillomavirus are selected from virus-like particles of HPV formed by HPV type L1 proteins 6, 11, 16, 18, 31, 33, 45, 52 and 58; and one or more HPV virus-like particles formed by L1 proteins of other HPV pathogen types selected from HPV types 35, 39, 51, 56 and 59, wherein said virus-like human papillomavirus particles are adsorbed on an adjuvant. Disclosed is a method for preventing an HPV-associated disease or infection, comprising administering to a subject a polyvalent vaccine of human papillomavirus virus-like particles, as well as use of said preparation for preparing a vaccine for preventing an HPV-associated disease or infection.

EFFECT: preparation can increase the stability of the vaccine and prolonging the action of the vaccine in an aqueous preparation.

17 cl, 17 tbl, 8 dwg, 6 ex