ABSTRACT
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.
Subject(s)
Antibodies, Neutralizing/blood , Antibodies, Viral/blood , Rabies Vaccines/administration & dosage , Rabies virus/drug effects , Rabies/prevention & control , Adult , Aged , Animals , Child , DNA, Viral/blood , Female , Humans , Immunization Schedule , Immunogenicity, Vaccine , Male , Mice , Middle Aged , Rabies/blood , Rabies/immunology , Rabies/virology , Rabies virus/genetics , Rabies virus/immunology , Rabies virus/pathogenicity , Vaccination/methods , Vaccine PotencyABSTRACT
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.
ABSTRACT
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.
