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Introduction. Taking into account the particular importance of the assurance of the safety of antiviral vaccines containing, albeit attenuated, but live viruses, that can possibly retain the residual neurovirulence, it is important to develop additional tests to confirm the stability of attenuation using modern methods of laboratory diagnostics.The aim of the study was to assess the possibility of using the RT-PCR method as an additional test for monitoring the residual neurovirulence of attenuated rubella virus vaccine strains.Materials and methods. We used live attenuated vaccine strains of rubella virus "Orlov-V" and RA27/3. The study was carried out on 11 clinically healthy monkeys of the species Macaca mulatta weighing 3–5 kg, born and kept in the nursery of the Research Institute of Medical Primatology. The clinical material studied was tissue samples from various parts of the central nervous system (CNS), regional lymph nodes, parenchymal organs, plasma and cerebrospinal fluid of experimental animals. Control of extraneural dissemination of vaccine strains was carried out using virological (cytopathic action) and molecular biological methods (RT-PCR).Results. The absence of an infectious virus in the CNS, peripheral organs and blood plasma of monkeys infected with vaccine strains was demonstrated, which indicates a high level of attenuation of rubella virus strains "Orlov-B" and RA27/3. The analytical sensitivity of the RT-PCR method was found to exceed the analytical sensitivity of the cytopathic reaction by 1.7–3.3 lg when determining the content of rubella virus in the tissues of the CNS and peripheral organs of inoculated animals.Conclusion. Comparative analysis of experimental data showed that the detection of rubella virus by real-time PCR has a number of advantages due its specificity, sensitivity and a shorter turnaround time. In this connection, the RT-PCR method can be used as an additional test in the preclinical assessment of specific safety, namely, extraneural dissemination of attenuated vaccine strains, which is essential for quality and safety control of live rubella vaccines.
Introduction. Taking into account the particular importance of the assurance of the safety of antiviral vaccines containing, albeit attenuated, but live viruses, that can possibly retain the residual neurovirulence, it is important to develop additional tests to confirm the stability of attenuation using modern methods of laboratory diagnostics.The aim of the study was to assess the possibility of using the RT-PCR method as an additional test for monitoring the residual neurovirulence of attenuated rubella virus vaccine strains.Materials and methods. We used live attenuated vaccine strains of rubella virus "Orlov-V" and RA27/3. The study was carried out on 11 clinically healthy monkeys of the species Macaca mulatta weighing 3–5 kg, born and kept in the nursery of the Research Institute of Medical Primatology. The clinical material studied was tissue samples from various parts of the central nervous system (CNS), regional lymph nodes, parenchymal organs, plasma and cerebrospinal fluid of experimental animals. Control of extraneural dissemination of vaccine strains was carried out using virological (cytopathic action) and molecular biological methods (RT-PCR).Results. The absence of an infectious virus in the CNS, peripheral organs and blood plasma of monkeys infected with vaccine strains was demonstrated, which indicates a high level of attenuation of rubella virus strains "Orlov-B" and RA27/3. The analytical sensitivity of the RT-PCR method was found to exceed the analytical sensitivity of the cytopathic reaction by 1.7–3.3 lg when determining the content of rubella virus in the tissues of the CNS and peripheral organs of inoculated animals.Conclusion. Comparative analysis of experimental data showed that the detection of rubella virus by real-time PCR has a number of advantages due its specificity, sensitivity and a shorter turnaround time. In this connection, the RT-PCR method can be used as an additional test in the preclinical assessment of specific safety, namely, extraneural dissemination of attenuated vaccine strains, which is essential for quality and safety control of live rubella vaccines.
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.
Introduction. Specific prevention of a number of infectious diseases has been introduced into the vaccination schedule. The production of immunoprophylactic drugs, in order to establish standard properties, including safety and specific effectiveness, requires strict adherence to manufacturing regulations, and the reliability of the results obtained requires monitoring of these parameters. The specific effectiveness of vaccine preparations is standardized according to the indicators of stimulation of specific antibody response formed in the body of vaccinated model biological objects. Objective. Determination of the immune reactivity of white mice to vaccination with the QazVac vaccine to establish the possibility of using them as a biological model in assessing the immunogenicity of the vaccine instead of Syrian hamsters. Materials and methods. The immune reactivity of model animals was assessed by the seroconversion rate, dynamics of antibody titers to the SARS-CoV-2 virus formed in the body after vaccination with the test vaccine. In the case of seropositivity of animals before administration of vaccine or placebo, the level of immune reactivity was calculated by the difference in antibody titers between control and vaccinated animals or by the difference in antibody titers before and after immunization. Specific antibodies were detected and their titer was determined using a neutralization reaction. Results. The research results showed that the tested biological models had approximately the same immune reactivity to the administration of the QazVac vaccine, confirmed by the level and dynamics of antibody titers. When analyzing the fold increase in antibody titers in comparison to those of control animals, Syrian hamsters were more reactive compared to mice. But SPF white mice were standardized in their lack of the immune reactivity to SARS-CoV-2 virus before the immunization. Conclusion. The data obtained indicate that the immune reactivity of white mice to the administration of the QazVac vaccine in terms of the rate and dynamics of the formation of virus-neutralizing antibodies is approximately equivalent to the immune reactivity of Syrian hamsters. Before immunization with the vaccine, SPF white mice, in contrast to Syrian hamsters, do not have humoral immunity specific to the SARS-CoV-2 virus. The immune reactivity equivalent to that observed of Syrian hamsters and the absence of antibodies to the SARS-CoV-2 virus at a baseline indicate the superiority of the use of white mice in assessing the immunogenicity of vaccines against COVID-19 and/or obtaining specific factors of humoral immunity.
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