[Experience with the use of pharmacopoeial reference material for the activity of measles vaccine].

INTRODUCTION: Due to the increased incidence of measles in Russia and in many other regions of the world, vaccines for the measles prevention are especially in demand. Ensuring the quality of the measles vaccine for effective disease prevention is within the scope of the tasks of the state policy of our country. OBJECTIVE: Evaluation of the experience of using a pharmacopoeial standard material of measles vaccine activity for measurement of the specific activity of the measles virus in vaccines with a measles component that are used in the Russian Federation for measles prevention. MATERIALS AND METHODS: The object of the study was the Pharmacopoeia reference material (PRM) of the activity of the live measles vaccine of series 10. The activity of PRM was analyzed when determining the specific activity of the measles, mumps-measles and combined vaccines for the prevention of measles, rubella and mumps, as well as based on the materials of the summary protocols for the production of these vaccines. RESULTS: The titer of the measles virus in the PRM for each determination of the specific activity of the measles virus in vaccines in the Scientific Centre for Expert Evaluation of Medicinal Products in 2021-2022, as well as according to the summary production protocols, was within the boundaries of the certified value (4.63 ± 0.5) lgTCD50/0.5 ml, and the test results met the acceptance criteria in accordance with the requirements of regulatory documentation. During the observation period, the average value of the PRM titer (4.61 lgTCD50/0.5 ml) practically did not differ compared to the average value of the certified characteristics of the PRM, the standard deviation of the mean value of the measles virus titer in the PRM did not exceed 0.15 lgTCD50, which indicated the stability of the analytical work at the enterprise and in IC. CONCLUSION: The data obtained indicate the stable activity of PRM, the correctness of the determination of the measles virus titer in the vaccination dose of the vaccine, and the validity of the method for monitoring the specific activity of the measles virus in vaccines.

[Quality analysis of a combined domestic vaccine for the prevention of measles, rubella and mumps].

INTRODUCTION: The need to maintain a high level of vaccination coverage against measles, rubella and mumps in conditions of an increased risk of outbreaks of infections due to violations of vaccination tactics associated with the pandemic of coronavirus infection and due to the unfavorable epidemic situation in neighboring countries determines the advisability of using a combined vaccine for the simultaneous prevention of these three socially significant infections. THE AIM OF THE STUDY: to analyze the quality of commercial series of a new domestic combined cultured live vaccine against measles, rubella and mumps (MRM) throughout the entire time of its manufacturing according to all specification indicators in regulatory documentation (RD). MATERIALS AND METHODS: The object of the study was the combined cultured live vaccine against measles, rubella and mumps. The analysis of the quality of the drug was carried out according to 86 consolidated production protocols of manufactured series, as well as according to the results of control of these series in the Testing Center for Quality Expertise of the Federal State Budgetary Institution NCESMP of the Ministry of Health of the Russian Federation. RESULTS: It is shown that the quality of the combined drug for the prevention of measles, rubella and mumps corresponds to the RD in all studied indicators. The drug does not contain an antibiotic. Bovine serum albumin, which is a technological impurity, is detected in quantities more than 5 times lower than the established norm. A comparison of the specific activity of the viral components of new combined domestic vaccine and the components of the bivalent vaccine against measles and mumps produced by the company in 20192021 showed that the spread of the activity values of the viral components in the new drug and in the series of mumps-measles vaccine was minimal, which allowed us to make a conclusion about the stability of the production technology. CONCLUSION: The quality of the new domestic combined vaccine for the prevention of measles, rubella and mumps meets WHO requirements. The results of the conducted studies indicate the stability of production and the standard quality of the drug. The use of a combined vaccine against three significant infections will ensure the necessary level of vaccination coverage in the population. Information about the results of studies can help reduce the number of vaccination refusal.

[Analysis of determination of rabies virus neutralizing antibody titres in the sera of vaccinated humans.]

INTRODUCTION: Rabies is an infectious disease that is always fatal following the onset of clinical symptoms. The only way to prevent the cases of rabies in humans is timely carried out the rabies post-exposure prophylaxis in accordance with the recommended schedule. OBJECTIVES: The aim of the study was to characterize the level of immune response in persons that received a post-exposure prophylaxis against rabies, to consider the role of the factors of the formation immune responses to rabies vaccines. MATERIAL AND METHODS: In the laboratory of viral vaccines of the Scientific Centre for Expert Evaluation of Medicinal Products, the 48 sera of patients that received the post-exposure prophylaxis of rabies after wounds from a rabid or suspected rabid animal has been studied. The titer of virus neutralizing antibodies (VNA) to the rabies virus in the sera of the vaccinated not less than 1:64 (corresponding to a level of VNA at least 0,5 IU /ml) in the mouse neutralization test indicates the effective vaccination. RESULTS AND DISCUSSION: Our data confirm the absence of statistically significant differences in the level of VNA in the vaccinated persons that received a complete and incomplete (5 doses) course of post-exposure vaccination against rabies. Depending on the level of VNA, all patients are divided into groups with conditionally low, medium and high content of antibodies in sera. CONCLUSION: It has been shown that in most cases properly administered vaccination contributed to the formation of effective immune response. The lack of a protective level of BHA requires additional administration of the vaccine and analysis of the factors that influenced the ineffectiveness of vaccination. In some patients the determination of rabies virus neutralizing antibody titres is necessary.

ANALYSIS OF THE QUALITY OF NATIONAL VACCINE AGAINST RUBELLA.

Until recently Rubella has been a wide spread infection. Thanks to vaccination against rubella, taking part in the global elimination program of "manageable infections" of WHO and adoption of the program "Elimination of measles and rubella in Russian Federation" the morbidity index of rubella has reached the sporadic level. One of the determining conditions of rubella elimination is application of high-quality vaccines that satisfy international standards. In Russian Federation, foreign rubella vaccines certified in our country were used for several years. In 2008, the commercial production of domestic vaccine began. It is widely known that the required quality of immunobiological medications is achieved using adequate production conditions and standard technological process. That is why during the production of domestic rubella vaccine, all the rules and requirements of Russian regulatory authorities and international recommendations are followed. In this article, a retrospective analysis of domestic vaccine against rubella according to laboratory options of quality in 2012-2017 is given. The results of the analysis show that the medication demonstrates stable high quality that is indicative of secure production technologies.

METHODS FOR ASSESSMENT OF THE SPECIFIC ACTIVITY OF DRUGS FOR PREVENTION OF HEPATITIS B.

The immunologic activity (specific activity) is one of the main indicators of quality of vaccines for prophylaxis of hepatitis B, along with their safety. Retrospective analysis of the use of laboratory methods for assessment of specific (immunogenic) activity of modern vaccines against hepatitis B using indicators was carried out: in vitro method based on evaluation of HBsAg content and in vivo method based on evaluation of immunogenic activity in mice. Both methods are standardized and described in normative documents on the vaccines against hepatitis B of domestic production registered in the Russian Federation. Indicators of specific (immunogenic) activity of vaccines against hepatitis B were used to investigate more than 170 vaccine series using the ELISA method in the period from 2013 to 2015. The obtained control results confirmed the expediency and efficiency of enzyme immunoassay for determination of HBsAg content, as well as permissibility of use of ready sets of the Murex HBsAg Version 3 test systems for testing vaccines against hepatitis B by the ELISA method. Analysis of the results of laboratory control of series of vaccines against hepatitis B using a biological method for immunogenicity evaluation based on ED50 analysis confirms persistently high immunogenic activity of the Russian commercial vaccines intended for prophylaxis of hepatitis B. The confirmed comparability of methods allows the number of in vivo tests to be further reduced in favor of the enzyme immunoassay authentically characterizing the produced drug.