VACCINE COMPOSITIONS AGAINST HUMAN PAPILLOMA VIRUS (HPV), CONTAINING ALUMINIUM ADJUVANT, AND METHODS OF PRODUCTION THEREOF Russian patent published in 2017 - IPC A61K39/12 A61K31/7004 A61P31/12 

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine, namely to immunology, and can be used for producing human papilloma virus vaccine. Vaccine composition against human papilloma virus includes: a) therapeutically effective amount of virus-like particles (VLP) HPV, adsorbed on aluminium adjuvant; b) mannitol and saccharose, c) optionally salt. Wherein composition contains: 1) virus-like particles HPV of at least one type, adsorbed on aluminium adjuvant, present in concentration equal to 10-200 mcg/ml, wherein virus-like particles are selected from group, consisting of: HPV6, HPV11, HPV16, HPV18, HPV26, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV53, HPV55, HPV56, HPV58, HPV59, HPV66, HPV68, HPV73 and HPV82; and 2) from approximately 1 % to approximately 10 wt/vol. of mannitol; and 3) from approximately 0.5 % to approximately 10 % of sucrose. Composition is frozen or lyophilized and composition is stable at storage during 1 month at 25 °C after stress caused by process of lyophilization or freezing-thawing. Group of inventions also relates to methods of producing said vaccine.

EFFECT: use of given inventions enables to obtain solid preparation of vaccine HPV (frozen or lyophilized) containing combination of excipients mannitol and saccharose, providing preservation of antigenicity of lyophilized vaccine preparation.

21 cl, 9 ex, 3 tbl, 15 dwg