FIELD: medicine.
SUBSTANCE: invention relates to a composition of a pneumococcal conjugate vaccine for induction of an immune response against Streptococcus pneumoniae. The composition contains 15-valent pneumococcal conjugate composition essentially consisting of S. pneumoniae polysaccharide of 1, 3, 4, 5, 6A, 6В, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F serotypes, wherein each serotype is conjugated with CRM197, 20 mM of histidine, pH of 5.8, 150 mM of NaCl, 250 mkg/ml of phosphate-aluminum adjuvant (APA), and 0.2% wt./vol. of polysorbate-20 (PS-20). The composition contains 4 mkg/ml of each serotype, excluding 6B, amount of which is 8 mkg/ml, and 64 mkg/ml of CRM197. Conjugates containing 6A, 6B, 7F, 18C, 19A, 19F, and 23F serotypes are obtained in DMSO conditions, and conjugates containing 1, 3, 4, 5, 9V, 14, 22F, and 33F serotypes are obtained in aqueous conditions.
EFFECT: invention provides a composition solution resistant to physical instability or aggregation occurring during a usual process of production, transportation, and processing.
1 cl, 16 dwg, 9 tbl, 14 ex
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Authors
Dates
2023-02-06—Published
2018-02-20—Filed