2 research outputs found
ΠΠ½Π°Π»ΠΈΠ· ΠΌΠ½ΠΎΠ³ΠΎΠ»Π΅ΡΠ½Π΅Π³ΠΎ ΠΎΠΏΡΡΠ° ΠΈΠ·ΡΡΠ΅Π½ΠΈΡ ΠΈΠ½Π°ΠΊΡΠΈΠ²ΠΈΡΠΎΠ²Π°Π½Π½ΡΡ ΠΊΡΠ»ΡΡΡΡΠ°Π»ΡΠ½ΡΡ Π²Π°ΠΊΡΠΈΠ½ Π΄Π»Ρ ΠΏΡΠΎΡΠΈΠ»Π°ΠΊΡΠΈΠΊΠΈ f ΠΊΠ»Π΅ΡΠ΅Π²ΠΎΠ³ΠΎ ΡΠ½ΡΠ΅ΡΠ°Π»ΠΈΡΠ° ΠΎΡΠ΅ΡΠ΅ΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΠΈ Π·Π°ΡΡΠ±Π΅ΠΆΠ½ΠΎΠ³ΠΎ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° -ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ (ΠΈΠΌΠΌΡΠ½ΠΎΠ³Π΅Π½Π½ΠΎΡΡΡ)
The analysis of the use of the method for the evaluation of specific (immunogenic) activity of vaccines for preventing tick-borne encephalitis (TBE vaccines) against protective dilution (PD50) and the minimum immunizing dose (MID50) has been performed. The method was standardized and submitted to the regulatory documents for TBE vaccines authorized in the Russian Federation. When analyzing the results of the study of specific (immunogenic) activity of TBE vaccines (107 TBE vaccine batches by different manufacturers have been studied) it was confirmed that the choice of real lethal dose (RLD50) indicator of TBE virus (test strain Β«AbsettarovΒ») in the range of 100-3000 LD50, the reasonability of using BALB /c cell-line mice, the effectiveness of the national method of determining immunogenicity in terms of MlD50 for TBE vaccines authorized in the Russian Federation. The reasonability of using immunogenicity reference standard for TBE-OSO 42-28-48 to assess the reproducibility of the experiments, and the homogeneity of laboratory animals in terms of quality. Methods for determining TBE vaccine immunogenicity (Β«specific activity (immunogenicity)Β» in terms of PD50 and MID50 is applicable both for Russian commercial TBE vaccines and for FSME-Immun vaccine, manufactured by Β«Baxter Vaccine AGΒ», Austria.ΠΡΠΎΠ²Π΅Π΄Π΅Π½ Π°Π½Π°Π»ΠΈΠ· ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΌΠ΅ΡΠΎΠ΄Π° ΠΎΡΠ΅Π½ΠΊΠΈ ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠΉ (ΠΈΠΌΠΌΡΠ½ΠΎΠ³Π΅Π½Π½ΠΎΠΉ) Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΡΠΎΠ²ΡΠ΅ΠΌΠ΅Π½Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½ ΠΊΠ»Π΅ΡΠ΅Π²ΠΎΠ³ΠΎ ΡΠ½ΡΠ΅ΡΠ°Π»ΠΈΡΠ° (Π²Π°ΠΊΡΠΈΠ½Ρ ΠΠ) ΠΏΠΎ ΠΏΡΠΎΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΠΌΡ ΡΠ°Π·Π²Π΅Π΄Π΅Π½ΠΈΡ (ΠΠ 50) ΠΈ ΠΌΠΈΠ½ΠΈΠΌΠ°Π»ΡΠ½ΠΎΠΉ ΠΈΠΌΠΌΡΠ½ΠΈΠ·ΠΈΡΡΡΡΠ΅ΠΉ Π΄ΠΎΠ·Π΅ (ΠΠΠ50). ΠΠ΅ΡΠΎΠ΄ ΡΡΠ°Π½Π΄Π°ΡΡΠΈΠ·ΠΎΠ²Π°Π½ ΠΈ Π²Π½Π΅ΡΠ΅Π½ Π² Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΡΠ΅ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΡ Π½Π° Π·Π°ΡΠ΅Π³ΠΈΡΡΡΠΈΡΠΎΠ²Π°Π½Π½ΡΠ΅ Π² Π ΠΎΡΡΠΈΠΉΡΠΊΠΎΠΉ Π€Π΅Π΄Π΅ΡΠ°ΡΠΈΠΈ Π²Π°ΠΊΡΠΈΠ½Ρ ΠΠ. ΠΡΠΈ Π°Π½Π°Π»ΠΈΠ·Π΅ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ² ΠΈΠ·ΡΡΠ΅Π½ΠΈΡ ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠΉ (ΠΈΠΌΠΌΡΠ½ΠΎΠ³Π΅Π½Π½ΠΎΠΉ) Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ Π²Π°ΠΊΡΠΈΠ½ ΠΠ (ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΎ 107 ΡΠ΅ΡΠΈΠΉ Π²Π°ΠΊΡΠΈΠ½ ΠΠ ΡΠ°Π·Π»ΠΈΡΠ½ΡΡ
ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΡΠ΅Π»Π΅ΠΉ) ΠΏΠΎΠ΄ΡΠ²Π΅ΡΠΆΠ΄Π΅Π½Ρ: Π²ΡΠ±ΠΎΡ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΡΠ΅Π°Π»ΡΠ½ΠΎΠΉ Π»Π΅ΡΠ°Π»ΡΠ½ΠΎΠΉ Π΄ΠΎΠ·Ρ (Π ΠΠ50) Π²ΠΈΡΡΡΠ° ΠΠ (ΡΠ΅ΡΡ-ΡΡΠ°ΠΌΠΌ Β«ΠΠ±ΡΠ΅ΡΡΠ°ΡΠΎΠ²Β») Π² ΠΏΡΠ΅Π΄Π΅Π»Π°Ρ
100-3000 ΠΠ50, ΡΠ΅Π»Π΅ΡΠΎΠΎΠ±ΡΠ°Π·Π½ΠΎΡΡΡ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ Π»ΠΈΠ½Π΅ΠΉΠ½ΡΡ
ΠΌΡΡΠ΅ΠΉ BALB/Ρ, ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΎΡΠ΅ΡΠ΅ΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΠΌΠ΅ΡΠΎΠ΄Π° ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΠΈΠΌΠΌΡΠ½ΠΎΠ³Π΅Π½Π½ΠΎΡΡΠΈ ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΠΠΠ50 Π΄Π»Ρ Π²Π°ΠΊΡΠΈΠ½ ΠΠ, Π·Π°ΡΠ΅Π³ΠΈΡΡΡΠΈΡΠΎΠ²Π°Π½Π½ΡΡ
Π² Π ΠΎΡΡΠΈΠΉΡΠΊΠΎΠΉ Π€Π΅Π΄Π΅ΡΠ°ΡΠΈΠΈ. ΠΠΎΠ΄ΡΠ²Π΅ΡΠΆΠ΄Π΅Π½Π° ΡΠ΅Π»Π΅ΡΠΎΠΎΠ±ΡΠ°Π·Π½ΠΎΡΡΡ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΡΡΠ°Π½Π΄Π°ΡΡΠ½ΠΎΠ³ΠΎ ΠΎΠ±ΡΠ°Π·ΡΠ° ΠΈΠΌΠΌΡΠ½ΠΎΠ³Π΅Π½Π½ΠΎΡΡΠΈ Π²Π°ΠΊΡΠΈΠ½Ρ ΠΠ - ΠΠ‘Π 42-28-48 Π΄Π»Ρ ΠΎΡΠ΅Π½ΠΊΠΈ ΡΡ
ΠΎΠ΄ΠΈΠΌΠΎΡΡΠΈ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ² ΠΏΠΎΡΡΠ°Π½ΠΎΠ²ΠΊΠΈ ΡΠΊΡΠΏΠ΅ΡΠΈΠΌΠ΅Π½ΡΠΎΠ² ΠΈ ΠΎΠ΄Π½ΠΎΡΠΎΠ΄Π½ΠΎΡΡΠΈ Π»Π°Π±ΠΎΡΠ°ΡΠΎΡΠ½ΡΡ
ΠΆΠΈΠ²ΠΎΡΠ½ΡΡ
ΠΏΠΎ ΠΊΠ°ΡΠ΅ΡΡΠ²Ρ. ΠΠ΅ΡΠΎΠ΄ ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΡ ΠΈΠΌΠΌΡΠ½ΠΎΠ³Π΅Π½Π½ΠΎΡΡΠΈ Π²Π°ΠΊΡΠΈΠ½ ΠΠ (ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Ρ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° Β«Π‘ΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠ°Ρ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ (ΠΈΠΌΠΌΡΠ½ΠΎΠ³Π΅Π½Π½ΠΎΡΡΡ)Β» ΠΏΠΎ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»ΡΠΌ ΠΠ 50 ΠΈ ΠΠΠ50 ΠΏΡΠΈΠΌΠ΅Π½ΠΈΠΌ ΠΊΠ°ΠΊ Π΄Π»Ρ ΡΠΎΡΡΠΈΠΉΡΠΊΠΈΡ
ΠΊΠΎΠΌΠΌΠ΅ΡΡΠ΅ΡΠΊΠΈΡ
Π²Π°ΠΊΡΠΈΠ½ ΠΠ, ΡΠ°ΠΊ ΠΈ Π΄Π»Ρ Π²Π°ΠΊΡΠΈΠ½Ρ Π€Π‘ΠΠ-ΠΠΌΠΌΡΠ½, ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° ΠΊΠΎΠΌΠΏΠ°Π½ΠΈΠΈ Β«ΠΠ°ΠΊΡΡΠ΅Ρ Π²Π°ΠΊΡΠΈΠ½Ρ ΠΠΒ», ΠΠ²ΡΡΡΠΈΡ
The analysis of a long-term experience of studying inactivated cell-culture vaccines for preventing tick-borne encephalitis of domestic and foreign manufacture in terms of specific activity (immunogenicity)
The analysis of the use of the method for the evaluation of specific (immunogenic) activity of vaccines for preventing tick-borne encephalitis (TBE vaccines) against protective dilution (PD50) and the minimum immunizing dose (MID50) has been performed. The method was standardized and submitted to the regulatory documents for TBE vaccines authorized in the Russian Federation. When analyzing the results of the study of specific (immunogenic) activity of TBE vaccines (107 TBE vaccine batches by different manufacturers have been studied) it was confirmed that the choice of real lethal dose (RLD50) indicator of TBE virus (test strain Β«AbsettarovΒ») in the range of 100-3000 LD50, the reasonability of using BALB /c cell-line mice, the effectiveness of the national method of determining immunogenicity in terms of MlD50 for TBE vaccines authorized in the Russian Federation. The reasonability of using immunogenicity reference standard for TBE-OSO 42-28-48 to assess the reproducibility of the experiments, and the homogeneity of laboratory animals in terms of quality. Methods for determining TBE vaccine immunogenicity (Β«specific activity (immunogenicity)Β» in terms of PD50 and MID50 is applicable both for Russian commercial TBE vaccines and for FSME-Immun vaccine, manufactured by Β«Baxter Vaccine AGΒ», Austria