International Journal of Accounting, Auditing and Performance Evaluation

Relevance. COVID-19, caused by the SARS-CoV-2 virus, remains a global public health threat despite the end of the pandemic. In the four years since the onset of the pandemic, the SARS-CoV-2 genome has undergone significant changes, particularly in the gene encoding the spike (S) protein. These changes resulted from the accumulation of immune responses in the human population, allowing the virus to evade the immune response. A significant proportion of the population was infected early in the pandemic or vaccinated with vaccines based on earlier variants of the virus. The emergence of new mutant variants raises concerns about the potential for severe COVID-19 in previously infected or vaccinated individuals.Аim. To examine the specifics of antibody formation, as well as the spectrum and functional activity of these antibodies in patients with COVID-19.Conclusions. Antibodies produced in response to infection or vaccination show diversity in spectrum and functional activity. Changes in the viral genome may reduce antibody effectiveness, highlighting the importance of monitoring new SARS-CoV-2 variants and developing adapted vaccines. These data will be key in shaping COVID-19 vaccination and treatment strategies in a changing epidemiological situation.

Relevance. Obtaining clean lysis spots, with tolerable presence of individual colonies of secondary growth, in spot tests is a criterion for assessing the effectiveness of therapeutic bacteriophages. At the same time, a number of mechanisms are known by which phage lysis of bacteria on lawns occurs without being accompanied by virus replication.Aim. To assess the ratio of spot test results and tests based on the detection of negative bacteriophage colonies.Conclusion. Data on 43 bacteriophages extracted from 21 articles were analyzed. Within the studied sample, the observation of clean lysis zones in 94% of cases corresponded to successful virus replication. For a number of Escherichia coli bacteriophages, a greater number of spot tests of the "++++" category were detected compared to the number of strains supporting virus replication, which, within the framework of assessing the lytic activity of a therapeutic bacteriophage, can be characterized as false positive spot test results. In general, the observation of clear lysis spots on the spot test in most cases indicates bacteriophage replication, which allows us to consider the spot test method as indicative, but requiring subsequent validation by more complex methods characterizing the efficiency of phage replication.

Relevance. Bartonelloses is a group of infectious diseases caused by bacteria from the Bartonella genus with a high zoonotic potential. This genus has a large genetic diversity, with many candidate species, and at least 20 known as a pathogenic for humans. However, the epidemiology of these diseases and their role in human infectious pathology are not well understood.Aim of this review is to collect and organize data in order to better understand the genetic diversity and distribution of Bartonella species, with a particular focus on those that are pathogenic to humans. We will also discuss the current state of research on the epidemiology of bartonelloses.Conclusions. Bartonella genus have the potential to be of significant epidemiological importance due to their wide species diversity and frequent occurrence in various ecological niches. However, there is currently no official registration of bartonelloses in the Russian Federation and laboratory confirmation resources are limited. As a result, bartonelloses remains an underestimated disease group among infectious disease specialists despite recent discoveries of Bartonella species.

Relevance. Major outbreaks, sporadic cases and intercontinental shipments of Bengal cholera caused by Vibrio cholerae O139 occurred from 1992 to 2018 in 26 countries, including 16 Asian countries.Аim. To characterize the spread of Bengal cholera in the world, including in Russia, in relation to the properties of V. cholerae O139.Results. Data on epidemic manifestations of Bengal cholera in the world, including in Russia, in relation to the phenotypic and molecular biological properties of V. cholerae O139 strains are presented. The evolution of their genome and the successive events of the introduction of V. cholerae O139 are described. Conclusion. The isolation of V. cholerae O139 from a patient with ctxAB+ gene, drug resistance to a number of antibiotics in China in 2023 indicates that the problem of Bengal cholera has been continued still in the modern period.

Relevance. Hepatitis B virus (HBV) is the etiologic agent of acute and chronic hepatitis B in humans. WHO recommends the use of sensitive laboratory assays based on nucleic acid amplification methods to detect HBV DNA. A method for detecting single copies of hepatitis B virus DNA using CRISPR/Cas systems was previously developed for ultrasensitive detection of HBV DNA.Aims. The aim of present study was to optimize the method for detecting single copies of hepatitis B virus DNA using CRISPR/Cas systems.Materials and methods. To obtain amplified fragments of the hepatitis B virus genome, 22 oligonucleotides were developed. The preliminary amplification stage was performed by the RPA method using the developed oligonucleotides. The assembly of CRISPR/ Cas ribonucleoprotein complexes specific for fragments of the hepatitis B virus genome was carried out using synthetic guide RNA (oligoribonucleotides). The detection stage was performed in HOLMES 1.Results and discussion. We maintained the sensitivity of the optimized method at the level of the original one (detection of single copies of hepatitis B virus DNA), when optimizing the method for detecting hepatitis B virus DNA. In addition, we reduced the time required for the analysis. Thus, the time required to detect single copies (6 copies per reaction) of hepatitis B virus DNA using the original method is 83 minutes, while for the optimized method it is 32 minutes.Conclusions. The optimized method for detecting single copies of hepatitis B virus DNA using CRISPR/Cas systems described in the article can be used in the future to develop new diagnostic kits, including point-of-care kits and/or kits to use in the field.

Relevance. Pandemic pathogen variants formation is a pressing issue of modern healthcare system thus classic approaches of preventive measures against infectious diseases require revision including implementation of effective, safe, universal and rapid methods of vaccine production.Aim. To conduct analysis of scientific literature concerning peculiarities of m-RNA and peptide vaccines. Search of publications was carried out in PubMed, Google Scholar and e-library databases.Conclusions. In addition to obvious advantages both vaccine platforms have disadvantages. m-RNA vaccines are thermally unstable and need to be stored and transported at temperature not exceeding minus 80 °C which significantly reduces their availability in countries with low income. m-RNA vaccine platform was chosen to manufacture vaccines against SARS-CoV-2 in Western countries (USA and Germany) during the COVID-19 pandemic despite the mentioned disadvantage. Most perspective mRNA vaccine prototypes vaccine were designed to combat influenza, respiratory syncytial virus, rabies, malaria, HIV, Ebola virus, Zika virus and cytomegalovirus. Peptide vaccines are undemanding to external factors such as temperature of storage and transportation. On the other hand, they need to be more immunogenic which is achieved by adding various adjuvants. They are also challenging to manufacture due complexity of quaternary structure of protein epitopes of antigens. To date, foreign peptide vaccines against influenza, HIV infection, hepatitis C, tuberculosis, malaria, and leishmaniasis have passed the first and second stages of clinical trials. Both mRNA and peptide vaccines undergo rapid degradation in human body, which prompts scientists to develop new molecular methods for delivering the vaccine matrix to target cells

Relevance. In the last decade, there has been an increase in the isolation of antibiotic-resistant microorganisms in community settings. Colonization and asymptomatic carriage of extended-spectrum beta-lactamase and carbapenemase producers can be a precursor to the development of an infectious process and a significant factor in the pathogenesis of healthcare-associated infections. Understanding the risk factors for community-acquired colonization with antibiotic-resistant microorganisms is necessary for targeted screening and timely implementation of measures to prevent the spread of resistance in hospitals.The aim. To determine significant risk factors for colonization with antibiotic-resistant gram-negative microorganisms and carriage of carbapenem resistance genes in patients admitted to a multidisciplinary hospital.Materials & Methods. A prospective single-center crosssectional study was conducted at the Moscow Multidisciplinary Clinical Center «Kommunarka» from 15.09.2022 to 15.08.2023. The study included 733 patients aged 18 to 94 years. Biological samples were taken from the rectum, upper and lower respiratory tract. The obtained samples were examined by real-time polymerase chain reaction (PCR) with hybridization-fluorescent detection of amplification products to identify carbapenemase genes and by culture method to determine colonization with carbapenemresistant bacteria. Identification of isolated microorganisms was performed using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS), and antibiotic susceptibility was determined by the Kirby-Bauer disk diffusion method on Mueller-Hinton agar. The results of susceptibility testing were interpreted based on EUCAST v12.0, v13.0, and v13.1 criteria.Results. Carriage of carbapenemase genes was detected in 12.6% of patients admitted to the hospital, while colonization with carbapenem-resistant bacteria was found in 2.7%. In the majority of patients (66.7%), the rectum was the only site of gene carriage. However, only 18.1% of these patients showed rectal colonization with carbapenem-resistant bacteria. This discrepancy is likely due to the higher sensitivity of molecular genetic methods compared to culture-based techniques. From a clinical perspective, the detection of nucleic acids by PCR can serve as an equivalent to pathogen detection in biological material. Multivariate analysis identified 5 independent predictors of colonization: cytostatic therapy, transfer from another hospital, need for vasopressor support, antibiotic use in the previous 3 months, and male gender.Conclusion. The identified risk factors allow for the identification of a highrisk patient cohort for targeted screening, enabling timely administration of appropriate antibiotic therapy and implementation of measures to prevent the spread of carbapenem resistance in the hospital.

Relevance. A distinctive feature of the influenza is the risk of severe complications, including cardiovascular (myocarditis or pericarditis) and nervous (encephalitis, meningoencephalitis and arachnoiditis) systems. Vaccination against influenza can significantly reduce the risk of disease, including complications and deaths.The aim of our study was to evaluate the epidemiological effectiveness of a quadrivalent inactivated split influenza vaccine in the 2023 –2024 season.Materials and methods. The study investigated the effectiveness of the tetravalent inactivated split vaccine Ultrix Quadri®. Vaccination data were collected in the regions of the Russian Federation as of January 1, 2024, in which a statistically significant amount of Ultrix Quadri® vaccine was used. The work was carried out using methods of variational statistics. The indicators of relative and attributive risks were evaluated, the Cochrane-Mantel-Hensel approach was applied, taking into account the assessment of heterogeneity of the results, and the effectiveness of the vaccine was evaluated.Results. The study showed that the risk of getting the flu among those vaccinated with Ultrix Quadri® vaccine was 122 (88-170) times lower than in those not vaccinated, which indicates the high epidemiological effectiveness of the vaccine. Cases of influenza among those vaccinated were observed in December 2023 - January 2024, that is, at the beginning of the epidemic season, during the period of the greatest rise in morbidity. At the same time, in absolute terms, their number was minimal. (414 cases out of 9.7 million vaccinated). From February to June 2024, the incidence of influenza among those vaccinated with the studied vaccine (with the exception of isolated cases) was not recorded.Conclusion. The conducted study demonstrated the high real epidemiological effectiveness of the Ultrix Quadri® vaccine during the epidemic season of influenza and ORI 2023/2024.

Relevance. The development and production of own vaccine contributes to the growth of professional competencies of the scientific community, improvement and modernization of the country's industrial production.Aims. To evaluate the immunogenicity parameters of whole-virion vaccine against SARS-CoV-2 in a phase I, II clinical trial (up to day 180).Materials & Methods. The clinical study included a phase I/II trial. In Phase I, a sequential allocation of subjects (1:1) by open-label method into two groups with a single administration of vaccine at dose 1 and at dose 2 was performed. In phase II (double-blind randomized), subjects were allocated to immunization with vaccine at doses 1, 2 or placebo in a 1:1:1 ratio. To evaluate the immunogenicity of an inactivated whole-virion booster vaccine against SARS-CoV-2 («BelCovidVac») in 135 healthy subjects (18–50 years of age in phase 1 and 18-60 years of age in phase 2) previously vaccinated/recovered from COVID-19. IgG concentration (BAU/mL) to the S-protein of SARS-CoV-2 was measured by the «SARS-CoV-2-IgG quantitative-ELISA-BEST» ELISA kit, viral neutralising activity of sera and proliferative activity of T-lymphocytes were evaluated, geometric mean (GMC) of IgG concentration was calculated, geometric mean of virus neutralizing activity titer (GMT compared to baseline. Statistical processing of the data was performed using the R programming language.Results. The values of fold change in IgG concentration to SARS-CoV-2 on day 42 and 90 in subjects who received «BelCovidVac» vaccine were significantly higher than those of subjects who received placebo (p=0,05, p=0,02, respectively). The value of the fold change in the titer of viral neutralizing activity in the study subjects who received «BelCovidVac» vaccine was significantly higher than the values of the subjects who received placebo (p=0,02). A statistically significant positive correlation (ρSp=0,51 p=0,0005) between the content of antigen-specific T-cells and the level of IgG after 28 days in the studied subjects and between the fold change in the titer of viral neutralizing activity of sera and the fold change in IgG concentration (ρSp = 0,40 p<0,001) was established. On day 180, all groups of subjects show a decrease in antigen-specific IgG concentrations to the initial level.Discussion. At the time of the search for volunteers and the beginning of the clinical trial of the vaccine «BelKovidVac» the immune layer of the population had already been formed, which made the task of the researchers more difficult. But the vaccine «BelKovidVac» showed its immunogenicity, as evidenced by the results of the study.Conclusions. A significant increase in GMC IgG and GMT viral neutralizing activity of sera in the group vaccinated with «BelCovidVac» and no significant increase in GMC IgG and GMT viral neutralizing activity of sera in the placebo group were revealed, which is the evidence of immune response stimulation as a result of «BelCovidVac» vaccine administration and its efficacy.

Relevance. Noroviruses are currently considered the most common cause of sporadic cases and community-acquired outbreaks of acute gastroenteritis (AGE) worldwide [1]. However, outbreaks of healthcare-associated infections (HAI) are also often caused by norovirus etiology [2], including in the Russian Federation [3].Aim. Analysis of key aspects of prevention and anti-epidemic measures against norovirus infection (NVI) in the hematology department.Materials and methods. The following epidemiological research methods were used: descriptive (intensity, dynamics, spatial characteristics of the NVI outbreak); analytical – longitudinal cohort study of the epidemic process of HAI – assessment of hypotheses about the causes and conditions, risk factors and routes of transmission of norovirus among patients and caregivers in the oncohematology department of the children's multidisciplinary hospital.Results and discussion. An outbreak of acute norovirus gastroenteritis of an imported nature was identified in the oncohematology department of a children's multidisciplinary hospital in February 2023, an analysis of the spread of NVI was carried out: the presumed source and mechanism of transmission of norovirus infection was established; the chronology of the spread of norovirus among patients and their caregivers is shown, a list of anti-epidemic measures taken to stop the outbreak is presented, and the difficulties of verifying the epidemiological diagnosis of HAI are reflected (based on the efficiency of laboratory testing of material from patients).Conclusion. Based on the results of the activities carried out, recommendations were proposed for improving preventive and anti-epidemic measures for acute gastroenteritis (AGE) in children's oncohematology departments.

Diseases of the respiratory system are leading in the structure of oncopathology in persons exposed to chronic radiation exposure in the low dose range. The objective of the work is characterize malignant neoplasms of the respiratory system in the Southern Urals Population Exposed to Radiation cohort over a long period of observation (71 years).Materials and methods. The South Urals Population Exposed to Radiation (SUPER) Cohort by accidents at the Mayak Production Association consists of 62 592 persons. We have detected 1023 cases of death from malignant neoplasms of respiratory system during the 71-year follow-up period. The total number of person-years at risk was 1 964 136. The study used a descriptive and analytical epidemiological method.Results. Deaths from malignant neoplasms of the respiratory system in the Southern Urals Population Exposed to Radiation cohort of the accidentally exposed population were registered in 898 men and 125 women. Mortality from respiratory cancer is significantly higher in men compared to women. The dependence of mortality growth on the age of initiation of exposure and its increase was revealed. Mortality is higher in the Russian ethnic group of the population compared with the ethnic group of Tatars and Bashkirs for all periods of observation, except for the period from 2016 to 2020. An increase in mortality from neoplasms of the respiratory system was revealed with an increase in the age reached and the age of initiation of exposure. The risk of mortality from of respiratory cancer is significantly higher in smokers.Conclusions. The study of oncopathology of respiratory tract in exposed people is undoubtedly of scientific and practical interest. The results can serve as a basis for development and improvement of preventive care programs for the affected population.

Obligate anaerobic difficult culture bacteria, which make up the bulk of the microbiota of the large intestine, are potential candidates for the development of highly effective new generation probiotics, since they are capable of synthesizing a variety of metabolites, including short-chain fatty acids, which have a stimulating effect on both commensal bacteria and host cells. However, for their long-term preservation, it is necessary to carefully select the preservation method and protective components. To evaluate the efficacy of using different cryoprotectants to increase the viability of obligate anaerobic difficult culture bacteria when preserved by lyophilisation and cryopreservation methods. The studies showed that freeze-drying contributed most to the preservation of the viability of Faecalibacterium prausnitzii, Anaerostipes hadrus, Eubacterium hallii, provided that they were used as a stabilizing medium, which included inulin, cysteine and riboflavin, ensuring the preservation of the initial bacterial titer for 30 days. Among the studied bacteria, the effectiveness of cryopreservation was shown for A. hadrus, since it ensured the survival of bacteria at the initial level for 14 days of storage, regardless of the cryopreservative used, but by the 30th day their viability decreased significantly (by 100 times when using liquid as a cryopreservant). nutrient medium 110 with minced meat and carbohydrates with the addition of glycerin, 10 000 with the commercial cryopreservative CRYOINSTANT). The results obtained allow us to recommend lyophilization as the most optimal method for long-term storage of probiotic strains of bacteria using highly effective stabilizers.

Purpose. Cancer is characterized by abnormal cell growth resulting from uncontrolled cell division. These cells spread and form metastatic lesions in normal tissues, leading to loss of tissue and organ function. Cancer is one of the most life-threatening diseases worldwide that develops in humans. regardless of sex, ethnicity, or nationality.Material and methods. Here, we conducted a retrospective study to collect data on the various types of cancers prevalent in Ninewa, Iraq, between 2017–2021, using hospital records pooled in the Iraq Cancer Registry. We focused on the top 10 most notable cancers prevalent in humans.Results. Our study revealed that number of novel cancer cases and mortality rates have been increasing annually between 2017– 2021. Females had higher rates of cancer occurrence than males. The most prevalent cancers in Ninewa were breast cancer in women and lung cancer in men. Leukemia was the most common pediatric cancer. Furthermore, this study reported that lung cancer had the highest mortality rate in Ninewa, followed by breast cancer.Conclusion Our study provides a statistical overview on cancer cases in the Ninewa governorate, and will be useful to clinicians, faculty members and other professionals in the medical field.

Relevance. In Russia and abroad, the incidence of cancer in situ (CIS) of the breast and cervix is most widely represented, the epidemiological features of this neoplasia of other localizations have not been studied sufficiently. Among them, a significant place is occupied by a group of malignant neoplasms in situ associated with the human papillomavirus (HPV), which have common etiopathogenetic mechanisms of development.The aim of the study was to determine the structure, as well as the incidence and mortality rates from HPV-associated cancer in situ among the population of St. Petersburg.Material and methods. The research materials included cases of cancer in situ of the oral cavity, pharynx, larynx, anal canal, vulva, vagina, cervix and penis in St. Petersburg in the period 2001 –2023. The calculation of the indicators was carried out according to the data of form No. 7 «Information on malignant neoplasms» and archival materials of the Population Cancer Registry of St. Petersburg. The analysis included 1952 cases of the disease and 50 deaths from malignant neoplasms, initially registered as cancer in situ. Research methods: retrospective epidemiological analysis and statistical methods.The results of the study. In the structure of in situ cancer associated with HPV, among the male population, the largest proportion was occupied by CIS of the larynx and penis (36.4% each), among the female population – cervix (94.9%). The average long-term incidence of cancer in situ of the oral cavity, pharynx, larynx, anal canal, vagina and penis was less than 0.1 per 100 thousand of the population with the maximum incidence in the age group of 50-69 years. From 2001 to 2023 in St. Petersburg, the incidence of cervical CIS decreased significantly from 6.86 to 1.17 per 100 thousand. the female population (p = 0.001), while since 2004, the highest incidence rate has been recorded annually in the 30 –39 age group. From 2001 to 2023, 11 cases (31.4% of all CIS localities) among males and 39 cases (27.7% of all CIS cases) among the female population became the cause of death from HPV-associated ZNO, initially registered as cancer in situ of the corresponding localizations.Conclusion. As a result of the study, epidemiological features of morbidity and mortality from HPVassociated cancer in situ of various localization in the conditions of St. Petersburg were established.

Relevance. The National vaccination schedule (NVS) of the Russian Federation includes 12 infections against 17–18 indicated in the Vaccination Schedules of most EU countries, and requires improvement in terms of expanding the number of infections and contingents subject to immunization, which is reflected in the «Strategy for the development of vaccine prevention of infectious diseases for the period up to 2035» and the roadmap for its implementation. Since the process of entry of new infections and new vaccines into NVS is quite «difficult» and economically costly (development of domestic vaccines, modernization of domestic enterprises, localization of production of foreign vaccines at Russian enterprises, formation of commitment of medical workers and public confidence in new immunobiological medicines), part of the tasks is to ensure public accessibility to vaccine prevention of infections not indicated in the The NVS can be successfully solved within the framework of regional vaccination schedules (RVS).Aims. To propose and interpret the concept of rational regional vaccination schedules, and also to outline the principles of its formation and assessment of the immediate and long-term prospects for the development of regional foundations of vaccination prevention.Results and discussion. RVS is an expanded version of NVS by including additional vaccine-controlled infections, taking into account the epidemic situation and the presence of high-risk groups of infection in the region. In modern conditions, RVS have been developed and are effectively used in a number of subjects of the Russian Federation, such as Moscow, Perm Krai, Sverdlovsk, Chelyabinsk, Tyumen Regions, Yamalo-Nenets Autonomous District, etc. The implementation of vaccine prophylaxis in the regions using this tool provides conditions for equal access of children and adults to modern highly effective vaccines, increases public awareness of the benefits and risks of vaccination and the level of population immunity, contributes to improving mechanisms for providing citizens with immunobiological drugs and the formation of epidemic well-being in the region based on a risk-based approach.Conclusions. In accordance with this paradigm, the authors introduce and interpret the concept of an «Rational regional vaccination schedules», define the basic principles of its formation and assess the short- and long-term prospects for the development of the regional foundations of vaccination.