Perspectives approach to the assessment of the quality of the vaccine plague live in terms of immunogenicity. Epidemiology and Vaccinal Prevention

Евгеньевна, Гостищева Светлана; Вячеславовна, Абзаева Наталья; Львовна, Ракитина Екатерина; Григорьевич, Пономаренко Дмитрий; Владимировна, Костюченко Марина; Васильевна, Логвиненко Ольга; Николаевич, Куличенко Александр

doi:10.31631/2073-3046-2019-18-1-50-54

Cited by 2 publications

(1 citation statement)

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“…известно, что ведущая роль в формировании адаптивного противочумного иммунитета отводится клеточным факторам иммунологической защиты [5][6][7]. ранее для определения иммуногенной активности вакцины чумной живой авторами разработан методический подход, основанный на антигенспецифических клеточных тестах in vitro и технологии проточной цитофлуориметрии [8].…”

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Comparative Analysis of the Immunogenic Activity of the Plague Vaccine Depending on the Growing Medium

Гостищева

Абзаева

Ракитина

et al. 2021

Problemy Osobo Opasnykh Infektsii

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The aim was to carry out a comparative analysis of the immunogenic activity of the live plague vaccine obtained on various nutrient media.Materials and methods. The subject of the study was the blood of outbred white mice immunized with a series of live plague vaccine based on Yersinia pestis EV NIIEG strain, produced using experimental and regulated nutrient media. The immunogenic activity of vaccines was studied through flow cytometry. The intensity of antigen-reactivity of lymphocytes was determined in cell tests in vitro, analyzing the early activation marker CD25+ . For the specific activation of lymphocytes, a complex of water-soluble antigens of the plague microbe was used. To identify the interdependence between the presence of protective anti-plague immunity and the level of CD 25+ expression intensity, the ED50 of the series under study was determined by the standard method.Results and discussion. A comparative analysis of the immunogenic activity of the live plague vaccine obtained on the experimental nutrient medium with the vaccine produced on Hottinger’s agar has been performed. When animals were immunized with doses of 4·103 , 2·104 and 1·105 live microbial cells (regulated doses), the highest level of expression of CD25 marker by lymphocytes was on the day 14, with a subsequent decrease on the day 21 after vaccination. When determining immunogenicity using the conventional method, a high degree of direct correlation between the number of surviving animals and an increase in the level of lymphocytes expressing markers of early activation has been established. Comparison has revealed the general pattern: when the lowest immunizing dose (8·102 ) was administered, activation of early immunity markers was not observed. In case of immunization with higher doses on days 7, 14 and 21, a proportional increase in the number of CD25-positive lymphocytes after stimulation with a specific antigen under in vitro conditions is detected in the blood of biomodels.

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Comparative Analysis of the Immunogenic Activity of the Plague Vaccine Depending on the Growing Medium

Гостищева

Абзаева

Ракитина

et al. 2021

Problemy Osobo Opasnykh Infektsii

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Analysis of current regulatory requirements for the quality of live bacterial vaccines and prospects for the improvement of vaccine quality control methods

Nemirovskaya,

Kasina,

Aleksandrova

et al. 2024

Biological Products. Prevention, Diagnosis, Treatment

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INTRODUCTION. Currently, there are live bacterial vaccines (LBVs) for the prevention of tuberculosis and particularly dangerous infections, such as plague, tularaemia, anthrax, and brucellosis. LBVs provide reliable and long-lasting protection. The high effectiveness of LBVs is due to their ability to mimic natural infections. Despite significant differences in LBV compositions, indications, and production species, the applicable quality control approaches share some common principles. At the same time, there are significant differences in methodological approaches to the assessment of a number of quality attributes, and some of these approaches require improvement and/or optimisation.AIM. This study aimed to analyse current regulatory requirements for the quality of LBVs having different compositions and indications, to identify the quality attributes of LBVs with the associated quality control methods in need of improvement, and to explore promising pathways for further development in this area.DISCUSSION. The review of regulatory standards and manufacturer specifications identified several quality attributes common to all LBVs. Vaccine identity was considered a key quality attribute. Motivated by the development of novel national diagnostic test systems, the authors analysed the performance of these test systems in practice to determine their potential for the identification of bacterial vaccines. In particular, immunochromatographic and serological techniques were successfully applied to the quality control of the tularaemia vaccine, a serological method was deemed suitable for brucellosis vaccines, and immunochromatography was recommended for plague and anthrax vaccines. A multiplex PCR method passed practical testing to be used for the quality control of BCG vaccines with reagents from Russian manufacturers. Flow cytometry was considered a promising technique for improving the quality control of LBVs in terms of viable units (tuberculosis and plague vaccines) and immunogenicity (plague vaccines).CONCLUSIONS. This analysis of regulatory requirements highlighted problematic issues related to the standardised quality attributes of LBVs and methods for their assessment. The literature review results and the authors’ own data indicate promising directions for improving the methodology of LBV quality assessment. One of these promising directions is the use of Russian-made commercial test systems for LBV identification.

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Perspectives approach to the assessment of the quality of the vaccine plague live in terms of immunogenicity. Epidemiology and Vaccinal Prevention

Cited by 2 publications

References 5 publications

Comparative Analysis of the Immunogenic Activity of the Plague Vaccine Depending on the Growing Medium

Comparative Analysis of the Immunogenic Activity of the Plague Vaccine Depending on the Growing Medium

Analysis of current regulatory requirements for the quality of live bacterial vaccines and prospects for the improvement of vaccine quality control methods

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