VACCINE COMPOSITIONS AGAINST HUMAN PAPILLOMA VIRUS (HPV), CONTAINING ALUMINIUM ADJUVANT, AND METHODS OF PRODUCTION THEREOF

摘要

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