Pub Date : 2024-07-10DOI: 10.31631/2073-3046-2024-23-3-47-56
S. Smirnova, Ylia S. Stagilskaya, I. A. Egorov, N. N. Zhuikov
Relevance. The healthcare personnel’s adherence to hand antisepsis is а pressing problem during any epidemic outbreak. In the context of high biological hazards, the possibility of performing proper antiseptic procedures is reduced while nosocomial pathogen transmission and healthcare-associated infection (HAI) rate growth are promoted. Aims. Studying the factors determining the healthcare workers’ adherence to hand antisepsis during a pandemic infection spread (as exemplified by COVID-19). Materials and methods. The study was conducted during the entire COVID-19 pandemic. To estimate the rate of adherence rate by the healthcare personnel to hand hygiene, we conducted an anonymous questionnaire survey of the staff in infectious disease hospitals (2021–2022) as well as assessed the viral and bacterial contamination rates of the personnel’s hands and the hospital environment items (2021–2023). Epidemiological (descriptive-evaluation), bacteriological (conventional culture, AMR determination using a VITEK2 analyzer), molecular biological (RT-PCR, Sanger sequencing) and statistical (a questionnaire survey, building machine learning models) methods were used in the study. Results. Based on the results of the survey, the main factors influencing the formation of attitudes towards antiseptics among the staff of medical organizations with medical and non-medical education were identified. It was found that the pandemic spread of infections negatively affects the level of contamination of the hands of infectious diseases hospital staff, which amounted to 35.3% of doctors, 28.8% of nurses, and 25% of hospital cleaners. The spectrum of isolated pathogens included viruses (SARS-CoV-2) and opportunistic microorganisms (Enterococcus faecalis, Enterococcus faecium, Pantoea agglomerans, Acinetobacter baumannii, Klebsiella pneumoniae, Staphylococcus aureus, Escherichia coli), including those with a wide profile of antimicrobial resistance. Conclusion. During the COVID-19 epidemic, the rate of adherence to hand antisepsis in the infectious disease hospital was 82.3% in the staff with a medical background and 71.2% in the staff without one. The results confirm the significant role of staff hands in the in-hospital transmission of dangerous pathogens and indicate the need for systematic monitoring of the level of knowledge on antiseptics among all employees of a medical organization, regardless of specialization and level of education.
{"title":"Factors Determining Adherence to Hand Antisepsis by Healthcare Workers during Pandemic Infection Spread (as exemplified by COVID-19)","authors":"S. Smirnova, Ylia S. Stagilskaya, I. A. Egorov, N. N. Zhuikov","doi":"10.31631/2073-3046-2024-23-3-47-56","DOIUrl":"https://doi.org/10.31631/2073-3046-2024-23-3-47-56","url":null,"abstract":"Relevance. The healthcare personnel’s adherence to hand antisepsis is а pressing problem during any epidemic outbreak. In the context of high biological hazards, the possibility of performing proper antiseptic procedures is reduced while nosocomial pathogen transmission and healthcare-associated infection (HAI) rate growth are promoted. Aims. Studying the factors determining the healthcare workers’ adherence to hand antisepsis during a pandemic infection spread (as exemplified by COVID-19). Materials and methods. The study was conducted during the entire COVID-19 pandemic. To estimate the rate of adherence rate by the healthcare personnel to hand hygiene, we conducted an anonymous questionnaire survey of the staff in infectious disease hospitals (2021–2022) as well as assessed the viral and bacterial contamination rates of the personnel’s hands and the hospital environment items (2021–2023). Epidemiological (descriptive-evaluation), bacteriological (conventional culture, AMR determination using a VITEK2 analyzer), molecular biological (RT-PCR, Sanger sequencing) and statistical (a questionnaire survey, building machine learning models) methods were used in the study. Results. Based on the results of the survey, the main factors influencing the formation of attitudes towards antiseptics among the staff of medical organizations with medical and non-medical education were identified. It was found that the pandemic spread of infections negatively affects the level of contamination of the hands of infectious diseases hospital staff, which amounted to 35.3% of doctors, 28.8% of nurses, and 25% of hospital cleaners. The spectrum of isolated pathogens included viruses (SARS-CoV-2) and opportunistic microorganisms (Enterococcus faecalis, Enterococcus faecium, Pantoea agglomerans, Acinetobacter baumannii, Klebsiella pneumoniae, Staphylococcus aureus, Escherichia coli), including those with a wide profile of antimicrobial resistance. Conclusion. During the COVID-19 epidemic, the rate of adherence to hand antisepsis in the infectious disease hospital was 82.3% in the staff with a medical background and 71.2% in the staff without one. The results confirm the significant role of staff hands in the in-hospital transmission of dangerous pathogens and indicate the need for systematic monitoring of the level of knowledge on antiseptics among all employees of a medical organization, regardless of specialization and level of education.","PeriodicalId":11736,"journal":{"name":"Epidemiology and Vaccinal Prevention","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141660233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-10DOI: 10.31631/2073-3046-2024-23-3-129-136
N. N. Kostyukova, V. A. Bekhalo
Relevance. Gonorrhea is a widespread infection. More than 80 million cases of this disease occur annually. The problem is compounded by the growing resistance of gonococcus to antibiotics worldwide. The only way out in this situation may be the immunization of certain groups of the population against this infection. Despite the numerous efforts of specialists, there is currently no registered vaccine against gonorrhea, which is due to the characteristics of the pathogen. However, over the past 30 years, reliable observations have accumulated that vaccines containing N. meningititidis serogroup B outer membrane proteins (OMP), developed for prophylaxis meningococcal infection, can also prevent a significant proportion of gonorrhea cases. Aims. To give a brief overview of publications on the reduction of the incidence of gonorrhea in individuals who received vaccines containing N. meningitidis serogroup B outer membrane vesicles, followed by an analysis of information about the nature of these proteins and methods of their study, as a promising platform for creating a vaccine against gonococcus. Conclusions. There is a theoretical and real possibility of creating a preventive drug against gonorrhea. Our analysis of literature sources showed that during the period 2006–2016 from 31% to 59% of those vaccinated with the protein meningococcal vaccine В were protected from gonorrhea. It is necessary to continue studying meningococcal OMV in terms of their preventive properties against gonorrhea, improve the set of models to identify their protective effect, and find adjuvants that enhance the immunogenicity of potential vaccine candidates.
相关性。淋病是一种广泛的传染病。每年有超过 8000 万例感染病例。淋球菌对抗生素的耐药性在全球范围内不断增强，使问题变得更加复杂。在这种情况下，唯一的出路可能就是对某些人群进行淋病免疫接种。尽管专家们做出了许多努力，但由于淋病病原体的特性，目前还没有注册的淋病疫苗。然而，在过去 30 年中，可靠的观察结果表明，为预防脑膜炎球菌感染而开发的含有 B 型脑膜炎球菌血清外膜蛋白（OMP）的疫苗也能预防相当一部分淋病病例。目的简要概述有关接种含有 B 型脑膜炎球菌血清外膜囊泡的疫苗可降低淋病发病率的出版物，然后分析有关这些蛋白的性质及其研究方法的信息，以此作为开发淋球菌疫苗的一个有前途的平台。结论。理论上和现实中都有可能研制出预防淋病的药物。我们对文献资料的分析表明，在 2006-2016 年期间，接种脑膜炎球菌疫苗 В 蛋白的人中有 31% 至 59% 的人免受淋病感染。有必要继续研究脑膜炎球菌 OMV 对淋病的预防特性，改进确定其保护效果的模型集，并找到能增强潜在候选疫苗免疫原性的佐剂。
{"title":"Serogroup B Protein Meningococcal Vaccines and the Formation of Immune Protection against Gonorrhea","authors":"N. N. Kostyukova, V. A. Bekhalo","doi":"10.31631/2073-3046-2024-23-3-129-136","DOIUrl":"https://doi.org/10.31631/2073-3046-2024-23-3-129-136","url":null,"abstract":"Relevance. Gonorrhea is a widespread infection. More than 80 million cases of this disease occur annually. The problem is compounded by the growing resistance of gonococcus to antibiotics worldwide. The only way out in this situation may be the immunization of certain groups of the population against this infection. Despite the numerous efforts of specialists, there is currently no registered vaccine against gonorrhea, which is due to the characteristics of the pathogen. However, over the past 30 years, reliable observations have accumulated that vaccines containing N. meningititidis serogroup B outer membrane proteins (OMP), developed for prophylaxis meningococcal infection, can also prevent a significant proportion of gonorrhea cases. Aims. To give a brief overview of publications on the reduction of the incidence of gonorrhea in individuals who received vaccines containing N. meningitidis serogroup B outer membrane vesicles, followed by an analysis of information about the nature of these proteins and methods of their study, as a promising platform for creating a vaccine against gonococcus. Conclusions. There is a theoretical and real possibility of creating a preventive drug against gonorrhea. Our analysis of literature sources showed that during the period 2006–2016 from 31% to 59% of those vaccinated with the protein meningococcal vaccine В were protected from gonorrhea. It is necessary to continue studying meningococcal OMV in terms of their preventive properties against gonorrhea, improve the set of models to identify their protective effect, and find adjuvants that enhance the immunogenicity of potential vaccine candidates. ","PeriodicalId":11736,"journal":{"name":"Epidemiology and Vaccinal Prevention","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141658815","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-10DOI: 10.31631/2073-3046-2024-23-3-57-66
T. Chekanova, Alexey V. Rakov, K. Petremgvdlishvili, A. V. Timonin, N. V. Lukyanenko, T. V. Safyanova, S. V. Shirokostup, N. Y. Lukyanenko, U. V. Kalinina, I. G. Pashchenko
Relevance. The Altai Кray with its administrative center, Barnaul, is an endemic region for tick–borne rickettsioses. The contribution of other tick-borne infections (TBI) to the structure of overall morbidity in the subject is significantly lower. To assess the risks of complication of the epidemiological situation for bacterial TBI (tick-borne rickettsioses, borrelioses, human granolucytic anaplasmoses, human monocytic ehrlichiosis, coxiellosis) and understand the level of their diagnosis in the region, it is important to study the occurrence of their pathogens in ticks, comparing them with the officially registered incidence. The aim is the study of the epidemiological and epizootological situation in Barnaul for bacterial tick-borne infections as well as an analysis of the factors influencing the registration of the incidence of these infections. Materials and methods. The materials were official statistical reporting data, information, analytical materials, accounting and reporting documentation of the Department of Rospotrebnadzor and the Ministry of Health of the Altai Region. The infection of ticks collected in the biotopes of Barnaul with different landscapes by pathogens of tick-borne encephalitis, human granulocytic anaplasmosis (HGA), human monocytic ehrlichiosis (HME), borrelioses, rickettsioses, and Q fever were studied using molecular biological methods. The species of Rickettsia were determined by Sanger sequencing followed by phylogenetic analysis. Results. Rickettsia conorii subsp. raoultii detected in the Dermacentor ticks with a high occurrence (61.9%), DNA of R. helvetica detected in the Ixodes ticks (5.1%). R. sibirica was not been detected. The infection rate of ticks by Borrelia burgdoferi s.l. was 27.8%; 5.1% of imagos contained B. miyamotoi DNA. Pathogens of HGA, HME were founded in 6.2%, 1.0% of individuals of Ixodes ticks, respectively. In two copies out of 300, the causative agent of Q fever identified. The dynamics of the number of people affected by tick bite over the period 2014-2023 did not tend to decrease, and against this background, there is a continuing high incidence of Siberian tick typhus, in contrast to the incidence of borreliosis. Other bacterial TBI have not been noted in Barnaul officially. Conclusions. In Barnaul, high risks of complications of the epidemiological situation of ixodic tick-borne borreliosis (including non-erythemic forms) have identified, and underdiagnosis of the disease is likely. The question of the etiological structure of tick-borne rickettsiosis, the occurrence of infected individuals with an atypical picture remains unknown. The difficulty of diagnostic of tick-borne rickettsiosis without rash is aggravated by the shortage of reagent kits, primarily for the detection of specific antibodies. The landscape confinement of Dermacentor and Ixodes ticks should take into account when organizing long-term stationary observation sites for monitoring and forecasting the epidemiological a
{"title":"Bacterial Infections Transmitted by Ticks in Barnaul: Epidemiological and Epizootological Situation, Diagnostic Problems","authors":"T. Chekanova, Alexey V. Rakov, K. Petremgvdlishvili, A. V. Timonin, N. V. Lukyanenko, T. V. Safyanova, S. V. Shirokostup, N. Y. Lukyanenko, U. V. Kalinina, I. G. Pashchenko","doi":"10.31631/2073-3046-2024-23-3-57-66","DOIUrl":"https://doi.org/10.31631/2073-3046-2024-23-3-57-66","url":null,"abstract":"Relevance. The Altai Кray with its administrative center, Barnaul, is an endemic region for tick–borne rickettsioses. The contribution of other tick-borne infections (TBI) to the structure of overall morbidity in the subject is significantly lower. To assess the risks of complication of the epidemiological situation for bacterial TBI (tick-borne rickettsioses, borrelioses, human granolucytic anaplasmoses, human monocytic ehrlichiosis, coxiellosis) and understand the level of their diagnosis in the region, it is important to study the occurrence of their pathogens in ticks, comparing them with the officially registered incidence. The aim is the study of the epidemiological and epizootological situation in Barnaul for bacterial tick-borne infections as well as an analysis of the factors influencing the registration of the incidence of these infections. Materials and methods. The materials were official statistical reporting data, information, analytical materials, accounting and reporting documentation of the Department of Rospotrebnadzor and the Ministry of Health of the Altai Region. The infection of ticks collected in the biotopes of Barnaul with different landscapes by pathogens of tick-borne encephalitis, human granulocytic anaplasmosis (HGA), human monocytic ehrlichiosis (HME), borrelioses, rickettsioses, and Q fever were studied using molecular biological methods. The species of Rickettsia were determined by Sanger sequencing followed by phylogenetic analysis. Results. Rickettsia conorii subsp. raoultii detected in the Dermacentor ticks with a high occurrence (61.9%), DNA of R. helvetica detected in the Ixodes ticks (5.1%). R. sibirica was not been detected. The infection rate of ticks by Borrelia burgdoferi s.l. was 27.8%; 5.1% of imagos contained B. miyamotoi DNA. Pathogens of HGA, HME were founded in 6.2%, 1.0% of individuals of Ixodes ticks, respectively. In two copies out of 300, the causative agent of Q fever identified. The dynamics of the number of people affected by tick bite over the period 2014-2023 did not tend to decrease, and against this background, there is a continuing high incidence of Siberian tick typhus, in contrast to the incidence of borreliosis. Other bacterial TBI have not been noted in Barnaul officially. Conclusions. In Barnaul, high risks of complications of the epidemiological situation of ixodic tick-borne borreliosis (including non-erythemic forms) have identified, and underdiagnosis of the disease is likely. The question of the etiological structure of tick-borne rickettsiosis, the occurrence of infected individuals with an atypical picture remains unknown. The difficulty of diagnostic of tick-borne rickettsiosis without rash is aggravated by the shortage of reagent kits, primarily for the detection of specific antibodies. The landscape confinement of Dermacentor and Ixodes ticks should take into account when organizing long-term stationary observation sites for monitoring and forecasting the epidemiological a","PeriodicalId":11736,"journal":{"name":"Epidemiology and Vaccinal Prevention","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141659457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-10DOI: 10.31631/2073-3046-2024-23-3-76-87
N. V. Vlasenko, M. D. Chanyshev, A. V. Peresadina, A. A. Grishaeva, T. A. Semenenko, A. Snitsar, L. V. Lyalina, S. N. Kuzin, K. Khafizov, V. Akimkin
Relevance. It is known that the immune response to the administration of immunobiological drugs is variable and depends on the individual characteristics of the organism. Host immunogenetic factors have a significant impact on the effectiveness of vaccination. In this study, the frequencies of alleles of the HLA class I (HLA-A, B, C) and class II genes (HLA-DRB1, DPB1, DQB1) were studied in groups of participants with different levels of antibodies (anti-HBs) after vaccination against viral hepatitis B. Aims of the work was to determine the possible relationship between alleles of HLA genes and the intensity of post-vaccination immunity against hepatitis B. Materials and methods. The study included 271 apparently healthy adults who were divided into 3 groups depending on the specific concentration of post-vaccination antibodies (anti-HBs) using ELISA. All calculations were made relative to the groups anti-HBs >100 mIU/ml (n=82), 10-100 mIU/ml (n=98) (protective antibody level) and anti-HBs <10 mIU/ml (n = 91). To type alleles of the HLA class I (HLA-A, B, C) and class II (HLA-DRB1, DPB1, DQB1) genes, we used a panel we developed for whole-genome next-generation sequencing (NGS). Statistical analysis was performed using Pearson's χ2 goodness-of-fit test using the FDR multiple correction method with an initial target of p < 0.05. Results. When typing the six genes studied, the total number of alleles identified at least once was 189 variants that were distinct from each other. We identified 3 alleles (B*38:01:01, DQB1*06:03:01 and DRB1*13:01:01), which were significantly more common (FDR p < 0.05) in the group with a protective level of anti-HBsS. Also in this group there was an increased frequency of occurrence of alleles A*26:01:01, A*32:01:01, C*12:03:01, DPB1*04:01:01 and haplotypes DQB1*06:03:01 -DRB1*13:01:01 and B*38:01:01-C*12:03:01. In the group of seronegative patients, alleles A*02:01:01, A*03:01:01, B*44:02:01, B*44:27:01, C*07:04:01, DPB1*04 were more common :01:01, DQB1*05:01:01, DRB1*01:01:01 and DRB1*16:01:01. It was shown that the identified associations were more significant in the group of individuals with a concentration of post-vaccination anti-HBs above 100 mIU/ml. Conclusion. The results obtained indicate that the HLA alleles we identified may influence the level of anti-HBsS production, and that the genetic factor may, to a greater extent, determine whether the antibody level exceeds 100 mIU/ml. defined as an anti-HBS level of 10 mIU/ ml. The development of an integrated approach to the organization of vaccine prevention, including the determination of genetic markers, will improve the quality of immunization of the population. Information about the association of HLA gene alleles can be used to develop predictive scenarios for the development of the hepatitis B epidemic process.
{"title":"Distribution of Major Histocompatibility Complex Alleles in Cohorts of Patients with Different Levels of Post-Vaccination Antibodies against Hepatitis B","authors":"N. V. Vlasenko, M. D. Chanyshev, A. V. Peresadina, A. A. Grishaeva, T. A. Semenenko, A. Snitsar, L. V. Lyalina, S. N. Kuzin, K. Khafizov, V. Akimkin","doi":"10.31631/2073-3046-2024-23-3-76-87","DOIUrl":"https://doi.org/10.31631/2073-3046-2024-23-3-76-87","url":null,"abstract":"Relevance. It is known that the immune response to the administration of immunobiological drugs is variable and depends on the individual characteristics of the organism. Host immunogenetic factors have a significant impact on the effectiveness of vaccination. In this study, the frequencies of alleles of the HLA class I (HLA-A, B, C) and class II genes (HLA-DRB1, DPB1, DQB1) were studied in groups of participants with different levels of antibodies (anti-HBs) after vaccination against viral hepatitis B. Aims of the work was to determine the possible relationship between alleles of HLA genes and the intensity of post-vaccination immunity against hepatitis B. Materials and methods. The study included 271 apparently healthy adults who were divided into 3 groups depending on the specific concentration of post-vaccination antibodies (anti-HBs) using ELISA. All calculations were made relative to the groups anti-HBs >100 mIU/ml (n=82), 10-100 mIU/ml (n=98) (protective antibody level) and anti-HBs <10 mIU/ml (n = 91). To type alleles of the HLA class I (HLA-A, B, C) and class II (HLA-DRB1, DPB1, DQB1) genes, we used a panel we developed for whole-genome next-generation sequencing (NGS). Statistical analysis was performed using Pearson's χ2 goodness-of-fit test using the FDR multiple correction method with an initial target of p < 0.05. Results. When typing the six genes studied, the total number of alleles identified at least once was 189 variants that were distinct from each other. We identified 3 alleles (B*38:01:01, DQB1*06:03:01 and DRB1*13:01:01), which were significantly more common (FDR p < 0.05) in the group with a protective level of anti-HBsS. Also in this group there was an increased frequency of occurrence of alleles A*26:01:01, A*32:01:01, C*12:03:01, DPB1*04:01:01 and haplotypes DQB1*06:03:01 -DRB1*13:01:01 and B*38:01:01-C*12:03:01. In the group of seronegative patients, alleles A*02:01:01, A*03:01:01, B*44:02:01, B*44:27:01, C*07:04:01, DPB1*04 were more common :01:01, DQB1*05:01:01, DRB1*01:01:01 and DRB1*16:01:01. It was shown that the identified associations were more significant in the group of individuals with a concentration of post-vaccination anti-HBs above 100 mIU/ml. Conclusion. The results obtained indicate that the HLA alleles we identified may influence the level of anti-HBsS production, and that the genetic factor may, to a greater extent, determine whether the antibody level exceeds 100 mIU/ml. defined as an anti-HBS level of 10 mIU/ ml. The development of an integrated approach to the organization of vaccine prevention, including the determination of genetic markers, will improve the quality of immunization of the population. Information about the association of HLA gene alleles can be used to develop predictive scenarios for the development of the hepatitis B epidemic process. ","PeriodicalId":11736,"journal":{"name":"Epidemiology and Vaccinal Prevention","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141660578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-10DOI: 10.31631/2073-3046-2024-23-3-88-97
P. Petrova, N. Konovalova, A. Boyarintseva, D. Danilenko, A. D. Vasilieva, T. N. Shelepanova, A. Prokopets, M. Eropkin
Relevance. The improvement of the surveillance of evolution of influenza viruses and the refinement of the capacity of prognostics of their evolutionary tendencies would lead to the better understanding and control on influenza epidemics. Aim. Establish the etiological nature of influenza epidemics in 2020–2023 in Russia and the antigenic properties of influenza viruses of the types A and B which circulated on its territory in 2020–2023. Methods. Isolation of influenza viruses from PCR+-clinical materials (nazo-pharingeal swabs and post-mortem tissue samples) in the cell lines MDCK and MDCK-Siat1; antigenic analysis by means of the reaction of hemagglutination-inhibition (HI) and micro-neutralization (MN) with the cell-ELISA detection using the post-infectious ferret antisera and rat polyclonal antisera; antigenic cartography. Results and discussion. The season 2020–2021 – the 1st season of pandemic of COVID-19, was characterized by quasi-total disappearance of influenza viruses from human population on the territory of REussia, probably as a consequence of stringent sanitary-hygienic measures worldwide due to COVID-19 pandemic. In the next epidemic season we could observe the domination of influenza viruses A(H3N2) during all season with the slight growth of the proportion of influenza B in the second part of the season. We could not isolate influenza viruses A(H1N1)pdm09 in that season due to their low epidemic activity, and the majority of isolated strains were А(H3N2) viruses – 94,4% of the total number of isolates. Influenza Вvic consisted 28 % of all number of isolates. The season 2022-23, opposite to the previous one, was characterized by the domination of influenza viruses of the sub-type А(H1N1)pdm09 what made it different from the epidemic in Europe and North America, where the A(H3N2) were prevalent, particularly in the first half of the epidemic season. Later on, the situation in Europe has changed and, as in Russia, influenza B actively introduced in circulation. The proportion of isolation of influenza viruses A(H1N1) pdm09 in Russia was 69,2 %, of influenza A(H3N2) – 3,5 %, of influenza Вvic – 27,3 %. Activation of A(H1N1)pdm09 viruses was probably a result of emergence of drift-variants of this sub-type during the epidemics what was supported by the data of antigenic and genetic analyses. Thus in 2020 the first isolates of a genetic clade 6В.1А5а were discovered. They possessed the key substitution N156K in the antigenic site Sb of НА1. The results of genetic analysis have shown that among the A(H1N1)pdm09 viruses of the last season which belonged to the clade 6В.1А.5а.2а, a group of viruses carrying the substitutions P137S, K142R, D260E, T277A in HA1 could be found, which are also present in the new vaccine strain А/Victoria/4897/2022 (genetic sub-group 6В.1А.5а.2а.1). This virus was recommended for the next season 2023-2024 for the Northern Hemisphere. Concerning the antigenic properties, the viruses having such substitutions pr
{"title":"Etiologic Characteristics of Influenza Epidemics on the Territory of Russia in the Period of Pandemic COVID-19 in 2020–2023","authors":"P. Petrova, N. Konovalova, A. Boyarintseva, D. Danilenko, A. D. Vasilieva, T. N. Shelepanova, A. Prokopets, M. Eropkin","doi":"10.31631/2073-3046-2024-23-3-88-97","DOIUrl":"https://doi.org/10.31631/2073-3046-2024-23-3-88-97","url":null,"abstract":"Relevance. The improvement of the surveillance of evolution of influenza viruses and the refinement of the capacity of prognostics of their evolutionary tendencies would lead to the better understanding and control on influenza epidemics. Aim. Establish the etiological nature of influenza epidemics in 2020–2023 in Russia and the antigenic properties of influenza viruses of the types A and B which circulated on its territory in 2020–2023. Methods. Isolation of influenza viruses from PCR+-clinical materials (nazo-pharingeal swabs and post-mortem tissue samples) in the cell lines MDCK and MDCK-Siat1; antigenic analysis by means of the reaction of hemagglutination-inhibition (HI) and micro-neutralization (MN) with the cell-ELISA detection using the post-infectious ferret antisera and rat polyclonal antisera; antigenic cartography. Results and discussion. The season 2020–2021 – the 1st season of pandemic of COVID-19, was characterized by quasi-total disappearance of influenza viruses from human population on the territory of REussia, probably as a consequence of stringent sanitary-hygienic measures worldwide due to COVID-19 pandemic. In the next epidemic season we could observe the domination of influenza viruses A(H3N2) during all season with the slight growth of the proportion of influenza B in the second part of the season. We could not isolate influenza viruses A(H1N1)pdm09 in that season due to their low epidemic activity, and the majority of isolated strains were А(H3N2) viruses – 94,4% of the total number of isolates. Influenza Вvic consisted 28 % of all number of isolates. The season 2022-23, opposite to the previous one, was characterized by the domination of influenza viruses of the sub-type А(H1N1)pdm09 what made it different from the epidemic in Europe and North America, where the A(H3N2) were prevalent, particularly in the first half of the epidemic season. Later on, the situation in Europe has changed and, as in Russia, influenza B actively introduced in circulation. The proportion of isolation of influenza viruses A(H1N1) pdm09 in Russia was 69,2 %, of influenza A(H3N2) – 3,5 %, of influenza Вvic – 27,3 %. Activation of A(H1N1)pdm09 viruses was probably a result of emergence of drift-variants of this sub-type during the epidemics what was supported by the data of antigenic and genetic analyses. Thus in 2020 the first isolates of a genetic clade 6В.1А5а were discovered. They possessed the key substitution N156K in the antigenic site Sb of НА1. The results of genetic analysis have shown that among the A(H1N1)pdm09 viruses of the last season which belonged to the clade 6В.1А.5а.2а, a group of viruses carrying the substitutions P137S, K142R, D260E, T277A in HA1 could be found, which are also present in the new vaccine strain А/Victoria/4897/2022 (genetic sub-group 6В.1А.5а.2а.1). This virus was recommended for the next season 2023-2024 for the Northern Hemisphere. Concerning the antigenic properties, the viruses having such substitutions pr","PeriodicalId":11736,"journal":{"name":"Epidemiology and Vaccinal Prevention","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141835391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-10DOI: 10.31631/2073-3046-2024-23-3-67-75
V. N. Borisova, R. Y. Maksvitis, R. V. Ivanov, T. A. Semenenko
Relevance. In Russia, phase III of clinical trials of the domestic trivalent vaccine Bubo®-Unigep, containing protective antigens that provide protection against “wild” forms of the hepatitis B virus subtypes ay and ad, as well as the determinant of serotype ay with the G145R mutation, has been completed. Аim. Evaluation of the effect of the new recombinant polyvaccine against hepatitis B «Bubo-Unigep» on vital functions and laboratory parameters in previously unvaccinated individuals in an adult healthy population. Materials and methods. A randomized multicenter clinical study was conducted to assess the reactogenicity, safety and immunogenicity of Bubo®-Unigep (CJSC NPC «COMBIOTECH») in previously unvaccinated healthy adults (n = 166). The study performed according to the protocol developed by the contract research organization «R&D Pharma» at eight clinical centers located in Russian Federation. Results and discussion. Analysis of the studied parameters throughout the study (frequency and severity of adverse events, physical examination data of volunteers with assessment of vital signs, laboratory test results, etc.) made it possible to establish a high safety profile of Bubo®-Unigep vaccine, which turned out to be virtually areactogenic without causing development of targeted local and systemic post-vaccination adverse events. Conclusion. The wide range of specificity of the immune response, along with the high safety and reactogenicity of the Bubo®-Unigep vaccine, the production of which can be carried out through a full technological cycle without the use of imported substances, will increase the effectiveness of hepatitis B prevention.
相关性。在俄罗斯，国产三价疫苗 Bubo®-Unigep 的第三阶段临床试验已经完成，该疫苗含有保护性抗原，可预防 "野生 "乙型肝炎病毒亚型 ay 和 ad 以及带有 G145R 突变的血清型 ay 的决定簇。Аim.评估新型乙型肝炎重组多联疫苗 "Bubo-Unigep "对成年健康人群中以前未接种过疫苗者的生命功能和实验室指标的影响。材料和方法。为评估 Bubo®-Unigep（CJSC NPC "COMBIOTECH"）在既往未接种过疫苗的健康成人（n = 166）中的反应原性、安全性和免疫原性，进行了一项随机多中心临床研究。研究按照合同研究组织 "R&D Pharma "制定的方案在俄罗斯联邦的八个临床中心进行。结果与讨论对整个研究过程中的研究参数（不良反应的频率和严重程度、志愿者的体格检查数据（包括生命体征评估）、实验室检测结果等）进行分析后发现，Bubo®-Unigep 疫苗具有很高的安全性。结论Bubo®-Unigep 疫苗具有广泛的免疫反应特异性、高安全性和反应原性，其生产可通过完整的技术周期进行，无需使用进口物质，这将提高乙型肝炎的预防效果。
{"title":"New Russian Trivalent Hepatitis B Vaccine (Bubo®-Unigep): Reactogenicity, Safety and Immunological Efficacy","authors":"V. N. Borisova, R. Y. Maksvitis, R. V. Ivanov, T. A. Semenenko","doi":"10.31631/2073-3046-2024-23-3-67-75","DOIUrl":"https://doi.org/10.31631/2073-3046-2024-23-3-67-75","url":null,"abstract":"Relevance. In Russia, phase III of clinical trials of the domestic trivalent vaccine Bubo®-Unigep, containing protective antigens that provide protection against “wild” forms of the hepatitis B virus subtypes ay and ad, as well as the determinant of serotype ay with the G145R mutation, has been completed. Аim. Evaluation of the effect of the new recombinant polyvaccine against hepatitis B «Bubo-Unigep» on vital functions and laboratory parameters in previously unvaccinated individuals in an adult healthy population. Materials and methods. A randomized multicenter clinical study was conducted to assess the reactogenicity, safety and immunogenicity of Bubo®-Unigep (CJSC NPC «COMBIOTECH») in previously unvaccinated healthy adults (n = 166). The study performed according to the protocol developed by the contract research organization «R&D Pharma» at eight clinical centers located in Russian Federation. Results and discussion. Analysis of the studied parameters throughout the study (frequency and severity of adverse events, physical examination data of volunteers with assessment of vital signs, laboratory test results, etc.) made it possible to establish a high safety profile of Bubo®-Unigep vaccine, which turned out to be virtually areactogenic without causing development of targeted local and systemic post-vaccination adverse events. Conclusion. The wide range of specificity of the immune response, along with the high safety and reactogenicity of the Bubo®-Unigep vaccine, the production of which can be carried out through a full technological cycle without the use of imported substances, will increase the effectiveness of hepatitis B prevention.","PeriodicalId":11736,"journal":{"name":"Epidemiology and Vaccinal Prevention","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141659411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-10DOI: 10.31631/2073-3046-2024-23-3-120-128
L. N. Tuychiev, B. M. Tadjiev, N. Tadjieva, O. S. Kasimov, A. M. Bektimirov, A. P. Yusupov, J. Anvarov, B. V. Shukurov
Relevance. The production of brucellosis diagnosticums is currently being established in the medical and veterinary practice of the Republic of Uzbekistan. However, due to the lack of a national standard serum in the country and the high cost of analog standard serums on the market, problems may arise in the production of diagnostic tools. In addition, the lack of national standard serums causes problems in quality control of commercial and local antigens, hinders the development of local drugs – brucellosis diagnostics, which reduces the effectiveness of serological diagnosis of brucellosis in humans and animals. Given the above, it becomes necessary to develop and produce a standard serum with a high level of safety, which will improve the methods of laboratory diagnosis of various forms of brucellosis in patients and animals to identify hidden foci of infection in Uzbekistan. The aim of the study is to obtain and characterize experimental standard diagnostic brucellosis rabbit sera for the development of national and industry standard serum with appropriate titers. Materials and Methods. The experiments were carried out in full compliance with the European Council Directive 2010/63/EU on compliance with ethical principles in working with laboratory animals and the experiments were carried out on the basis of the methodological manual «Methods and rules of work» approved by the Ministry of Health of the Republic of Uzbekistan in 2016 with laboratory animals in experimental microbiological and immunological studies. To obtain positive standard sera against brucellosis pathogens, 12 rabbits weighing from 2.2 kg to 4.6 kg, aged 6 to 12 months, were used. The animals were kept under identical conditions on a standard vivarium diet. For the experiment, animals adapted to the conditions of the study were selected and kept in quarantine for 21 days. The maintenance and conduct of the studies followed international rules for the humane treatment of animals. Results and Discussion. During the evaluation of the heterologic specificity of the obtained sera for 23 collection and hospital strains, a weakly positive response (+) was observed in 16.7% of cases. Rabbit sera positive for heterologic specificity were adsorbed on suspensions of inactivated microorganisms (Citrobacter spp. and Enterobacteriaceae spp.) - no significant drop in titer was observed, and cross-agglutination was eliminated. A significant increase in the total protein level was noted after the first and fourth immunizations. Before the first immunization, the total protein level was 59.57 g/l, and after the fourth immunization, it increased threefold to 157.17 g/l. There was also an increase in albumin and globulin (33.2 g/L and 26.37 g/L, respectively) to 79.37 g/L and 77.43 g/L, respectively. IgM levels remained almost unchanged, increasing 3.5-fold after the second immunization and decreasing to 0.24 mg/ml after the fourth immunization. An increase in the level of IgG after the second
{"title":"Obtaining and Characterization of Experimental Diagnostic Brucellosis Rabbit Sera for the Development of a National Standard for Brucellosis Serum","authors":"L. N. Tuychiev, B. M. Tadjiev, N. Tadjieva, O. S. Kasimov, A. M. Bektimirov, A. P. Yusupov, J. Anvarov, B. V. Shukurov","doi":"10.31631/2073-3046-2024-23-3-120-128","DOIUrl":"https://doi.org/10.31631/2073-3046-2024-23-3-120-128","url":null,"abstract":"Relevance. The production of brucellosis diagnosticums is currently being established in the medical and veterinary practice of the Republic of Uzbekistan. However, due to the lack of a national standard serum in the country and the high cost of analog standard serums on the market, problems may arise in the production of diagnostic tools. In addition, the lack of national standard serums causes problems in quality control of commercial and local antigens, hinders the development of local drugs – brucellosis diagnostics, which reduces the effectiveness of serological diagnosis of brucellosis in humans and animals. Given the above, it becomes necessary to develop and produce a standard serum with a high level of safety, which will improve the methods of laboratory diagnosis of various forms of brucellosis in patients and animals to identify hidden foci of infection in Uzbekistan. The aim of the study is to obtain and characterize experimental standard diagnostic brucellosis rabbit sera for the development of national and industry standard serum with appropriate titers. Materials and Methods. The experiments were carried out in full compliance with the European Council Directive 2010/63/EU on compliance with ethical principles in working with laboratory animals and the experiments were carried out on the basis of the methodological manual «Methods and rules of work» approved by the Ministry of Health of the Republic of Uzbekistan in 2016 with laboratory animals in experimental microbiological and immunological studies. To obtain positive standard sera against brucellosis pathogens, 12 rabbits weighing from 2.2 kg to 4.6 kg, aged 6 to 12 months, were used. The animals were kept under identical conditions on a standard vivarium diet. For the experiment, animals adapted to the conditions of the study were selected and kept in quarantine for 21 days. The maintenance and conduct of the studies followed international rules for the humane treatment of animals. Results and Discussion. During the evaluation of the heterologic specificity of the obtained sera for 23 collection and hospital strains, a weakly positive response (+) was observed in 16.7% of cases. Rabbit sera positive for heterologic specificity were adsorbed on suspensions of inactivated microorganisms (Citrobacter spp. and Enterobacteriaceae spp.) - no significant drop in titer was observed, and cross-agglutination was eliminated. A significant increase in the total protein level was noted after the first and fourth immunizations. Before the first immunization, the total protein level was 59.57 g/l, and after the fourth immunization, it increased threefold to 157.17 g/l. There was also an increase in albumin and globulin (33.2 g/L and 26.37 g/L, respectively) to 79.37 g/L and 77.43 g/L, respectively. IgM levels remained almost unchanged, increasing 3.5-fold after the second immunization and decreasing to 0.24 mg/ml after the fourth immunization. An increase in the level of IgG after the second","PeriodicalId":11736,"journal":{"name":"Epidemiology and Vaccinal Prevention","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141659236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-10DOI: 10.31631/2073-3046-2024-23-3-98-106
E. Bogorodskaya, I. V. Nozdrevatykh, E. L. Khristoforova, E. M. Belilovsky
Relevance. Studying the experience of working under the conditions of COVID-19 allows us to more effectively assess the functioning of anti-epidemic measures in the event of the occurrence or threat of new pandemics, including those caused by new pathogens. The risk of contracting COVID-19 among employees of medical organizations is higher compared to the rest of the population of the metropolis, which determines the need to develop additional measures in medical organizations to protect workers. Timely assessment of risks and preventive measures during a pandemic allow building a system to protect medical institutions from various biological threats when providing medical care. Aim. Assessment of the risks of contracting COVID-19 among employees of a large anti-tuberculosis medical organization in a metropolis. Materials & Methods. A survey of employees of a large anti-tuberculosis medical organization in Moscow was conducted. The survey was conducted on 46 key questions of epidemiological history, compliance with the requirements of the sanitary and anti-epidemic regime, alleged sources of infection, prognostic risks of the occurrence and course of COVID-19. During the period from August 1 to October 1, 2022, 1225 employees of the institution were surveyed (43.8% of the total number). The survey was conducted on a voluntary basis and was anonymous. When answering questions, participants provided information about demographic factors (age, gender), place of actual residence, the fact of contracting a new coronavirus infection, frequency of laboratory testing for SARS-CoV-2, immunization against COVID-19, possible places of contact with patients with COVID-19, the use of personal protective equipment (PPE) at home and at work, the regular use of skin antiseptics, as well as other information that allowed us to establish the risks of infection of workers at home and at work. To assess the risks of infection, respondents were divided into two groups depending on the presence of a positive test for SARS-CoV-2 (group I) or its absence (group II) as of October 1, 2022. The material for testing was nasal/oropharyngeal swabs. The research of employees was carried out on the basis of the laboratory of the anti-tuberculosis medical organization, as well as in other accredited laboratories of the metropolis using the molecular genetic method, and since February 2022 also using the express method that determines the SARS-CoV-2 antigen. Results. Among the survey participants and according to the questionnaire data, 797 employees suffered from the new coronavirus infection COVID-19, and 138 (17.3%) of them had repeated cases of the disease. Factors that increase the risk of COVID-19 among personnel of anti-tuberculosis medical organizations directly involved in the fight against the new coronavirus infection have been identified. The results of the study demonstrated that important factors influencing the incidence of workers were the frequency of examination
{"title":"Risk of COVID-19 Infection among Employees of a Large Antituberculosis Institution in Moscow: Survey Results","authors":"E. Bogorodskaya, I. V. Nozdrevatykh, E. L. Khristoforova, E. M. Belilovsky","doi":"10.31631/2073-3046-2024-23-3-98-106","DOIUrl":"https://doi.org/10.31631/2073-3046-2024-23-3-98-106","url":null,"abstract":"Relevance. Studying the experience of working under the conditions of COVID-19 allows us to more effectively assess the functioning of anti-epidemic measures in the event of the occurrence or threat of new pandemics, including those caused by new pathogens. The risk of contracting COVID-19 among employees of medical organizations is higher compared to the rest of the population of the metropolis, which determines the need to develop additional measures in medical organizations to protect workers. Timely assessment of risks and preventive measures during a pandemic allow building a system to protect medical institutions from various biological threats when providing medical care. Aim. Assessment of the risks of contracting COVID-19 among employees of a large anti-tuberculosis medical organization in a metropolis. Materials & Methods. A survey of employees of a large anti-tuberculosis medical organization in Moscow was conducted. The survey was conducted on 46 key questions of epidemiological history, compliance with the requirements of the sanitary and anti-epidemic regime, alleged sources of infection, prognostic risks of the occurrence and course of COVID-19. During the period from August 1 to October 1, 2022, 1225 employees of the institution were surveyed (43.8% of the total number). The survey was conducted on a voluntary basis and was anonymous. When answering questions, participants provided information about demographic factors (age, gender), place of actual residence, the fact of contracting a new coronavirus infection, frequency of laboratory testing for SARS-CoV-2, immunization against COVID-19, possible places of contact with patients with COVID-19, the use of personal protective equipment (PPE) at home and at work, the regular use of skin antiseptics, as well as other information that allowed us to establish the risks of infection of workers at home and at work. To assess the risks of infection, respondents were divided into two groups depending on the presence of a positive test for SARS-CoV-2 (group I) or its absence (group II) as of October 1, 2022. The material for testing was nasal/oropharyngeal swabs. The research of employees was carried out on the basis of the laboratory of the anti-tuberculosis medical organization, as well as in other accredited laboratories of the metropolis using the molecular genetic method, and since February 2022 also using the express method that determines the SARS-CoV-2 antigen. Results. Among the survey participants and according to the questionnaire data, 797 employees suffered from the new coronavirus infection COVID-19, and 138 (17.3%) of them had repeated cases of the disease. Factors that increase the risk of COVID-19 among personnel of anti-tuberculosis medical organizations directly involved in the fight against the new coronavirus infection have been identified. The results of the study demonstrated that important factors influencing the incidence of workers were the frequency of examination","PeriodicalId":11736,"journal":{"name":"Epidemiology and Vaccinal Prevention","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141661426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-10DOI: 10.31631/2073-3046-2024-23-3-107-119
I. Stoma, E. Voropaev, E. I. Mikhailova, D. M. Los’, O. Osipkina, A. Y. Braga, A. Kovalev, A. V. Molchanova, N. V. Trofimova, O. S. Pershenkova, B. S. Yaroshevich, M. N. Mirge
Relevance. According to the World Health Organization (WHO), it is not yet possible to effectively stop the spread of new strains of coronavirus [1]. At the same time, most experts and analysts in the field of medicine publicly admit that at the moment vaccination is the most powerful weapon in the fight against COVID-19 [2–6]. While vaccination, like the entire health care system, has now become an element of politics and economics, the creation of proprietary vaccine in each country has become an element of national security [7]. Aims. To evaluate the safety of the inactivated booster vaccine «BelCovidVac» in immunized study subjects from 18 to 60 years old (day 28). Materials and methods. A prospective, randomized, double-blind phase I/II trial evaluated the safety of an inactivated whole virion booster vaccine against the SARS-CoV-2 virus in two doses in healthy study subjects aged 18 to 60 years who had completed a full course of vaccination with the SARS-CoV-2 virus and/or recovered from COVID-19, which included 129 subjects (24 in phase 1 and 105 in phase 2). Results. The study reported 195 adverse reactions in 94 study subjects. The study reported 80 adverse reactions in 24 (100%) study subjects at Phase 1, and 115 adverse reactions in 70 subjects at Phase 2. The study detected mild adverse reactions in 77,50% of cases at Phase 1, and in 71,30% at Phase 2. Moreover, the study found one serious adverse reaction in 1 subject at Phase 2, which occurred as a result of taking placebo. The incidence of adverse reactions with the use of the candidate vaccine in two doses is comparable to placebo (2 = 3,15, p = 0,08). Conclusion. The vaccine candidate demonstrated good tolerability at both Phase 1 and Phase 2.
{"title":"Safety Assessment of Inactivated Whole Virion Booster Vaccine against the SARS-CoV-2 Virus (BelCovidVac) in Immunized Study Subjects aged 18 to 60 Years (day 28)","authors":"I. Stoma, E. Voropaev, E. I. Mikhailova, D. M. Los’, O. Osipkina, A. Y. Braga, A. Kovalev, A. V. Molchanova, N. V. Trofimova, O. S. Pershenkova, B. S. Yaroshevich, M. N. Mirge","doi":"10.31631/2073-3046-2024-23-3-107-119","DOIUrl":"https://doi.org/10.31631/2073-3046-2024-23-3-107-119","url":null,"abstract":"Relevance. According to the World Health Organization (WHO), it is not yet possible to effectively stop the spread of new strains of coronavirus [1]. At the same time, most experts and analysts in the field of medicine publicly admit that at the moment vaccination is the most powerful weapon in the fight against COVID-19 [2–6]. While vaccination, like the entire health care system, has now become an element of politics and economics, the creation of proprietary vaccine in each country has become an element of national security [7]. Aims. To evaluate the safety of the inactivated booster vaccine «BelCovidVac» in immunized study subjects from 18 to 60 years old (day 28). Materials and methods. A prospective, randomized, double-blind phase I/II trial evaluated the safety of an inactivated whole virion booster vaccine against the SARS-CoV-2 virus in two doses in healthy study subjects aged 18 to 60 years who had completed a full course of vaccination with the SARS-CoV-2 virus and/or recovered from COVID-19, which included 129 subjects (24 in phase 1 and 105 in phase 2). Results. The study reported 195 adverse reactions in 94 study subjects. The study reported 80 adverse reactions in 24 (100%) study subjects at Phase 1, and 115 adverse reactions in 70 subjects at Phase 2. The study detected mild adverse reactions in 77,50% of cases at Phase 1, and in 71,30% at Phase 2. Moreover, the study found one serious adverse reaction in 1 subject at Phase 2, which occurred as a result of taking placebo. The incidence of adverse reactions with the use of the candidate vaccine in two doses is comparable to placebo (2 = 3,15, p = 0,08). Conclusion. The vaccine candidate demonstrated good tolerability at both Phase 1 and Phase 2.","PeriodicalId":11736,"journal":{"name":"Epidemiology and Vaccinal Prevention","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141660536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-09DOI: 10.31631/2073-3046-2024-23-3-19-26
D. Kvashnina, I. Shirokova, N. Belyanina, O. V. Ivanova, N. V. Stifeev, O. Kovalishena, S. A. Syrbu, N. Lebedeva
Relevance. The development of antimicrobial drugs and alternative methods, technologies and means of prevention, diagnosis and treatment of human infectious diseases caused by antibiotic-resistant microorganisms is one of the priorities of ensuring the biological safety of the country. Aims. To evaluate the bactericidal activity of tetrapyrrole macroheterocycles (porphyrins) at different light irradiation durations in relation to staphylococci, in vitro. Materials and methods. Studied strains of microorganisms: museum strains of microorganisms – S. aureus ATCC 29213, S. epidermidis ATCC 14990 and antibiotic-resistant strains of bacteria of the genus Staphylococcus (n=18) isolated from clinical biomaterial and from environmental objects in a medical organization. The studied chemical compounds are three different compounds of water-soluble asymmetrically substituted porphyrins containing heterocyclic fragments on the periphery of the porphyrin cycle (residues of benzoxazole, N-methylbenzimidazole and benzothiazole). Results. The activity of all three porphyrin compounds in relation to museum strains of staphylococcus and 77.8% of clinical antibiotic-resistant strains (n=14; 95% CI 20.1-97.5) turned out to be maximal (complete lysis) after 10 minutes of irradiation. Conclusions. The tested tetrapyrrole macroheterocycles (porphyrins) exhibit bactericidal activity against museum and clinical strains of staphylococcus, with different levels of antibiotic resistance, which determines Keywords: antibiotic resistance, water-soluble porphyrin, photodynamic inactivation, photosensitizer, photochemistry, staphylococci No conflict of interest to declare.
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