Global polio eradication requires both safe and effective vaccines, and safe production processes. Sabin oral poliomyelitis vaccine (OPV) strains can evolve to virulent viruses and result in poliomyelitis outbreaks, and conventional inactivated poliomyelitis vaccine (Salk-IPV) production includes accumulation of large stocks of neurovirulent wild polioviruses. Therefore, IPV based on attenuated OPV strains seems a viable option. To increase the global supply of affordable inactivated vaccine in the still not-polio free world we developed an IPV made from the Sabin strains–PoliovacSin. Clinical trials included participants 18–60 years of age. A phase I single-center, randomized, double-blind placebo-controlled clinical trial included 60 participants, who received one dose of PoliovacSin or Placebo. A phase II multicenter, randomized, double-blind, comparative clinical trial included 200 participants, who received one dose of PoliovacSin or Imovax Polio. All vaccinations were well tolerated, and PoliovacSin had a comparable safety profile to the Placebo or the reference Imovax Polio preparations. A significant increase in neutralizing antibody levels to polioviruses types 1–3 (Sabin and wild) was observed in PoliovacSin and Imovax Polio vaccinated groups. Therefore, clinical trials confirmed good tolerability, low reactogenicity, and high safety profile of the PoliovacSin and its pronounced immunogenic properties. The preparation was approved for clinical trials involving infants.
Pneumococcal infections are among the most common infections are an important cause of morbidity and mortality worldwide, including Russia. At the end of 2014 in the national immunization schedule countries introduced vaccination against pneumococcal infection The aim of study. To assess the epidemiological effectiveness of vaccination against pneumococcal infection in young children selectively in different territories of the Russian Federation 2 years later from its beginning Materials and methods. In the course of epidemiological observational analytical research of type «case-control» data were obtained on the incidence in vaccinated and unvaccinated against pneumococcal infection in children from 2 months to 2 years We analyzed 1422 outpatients and 356 case histories of children in several cities (Moscow, Smolensk, Sevastopol, Perm, Tyumen, Barnaul). The results are subjected to statistical processing The results and discussion Established that there is a reliable causal connection between the lack of vaccination of children against pneumococcal infection and incidence of diseases. Shows high prophylactic efficacy of vaccination of children up to 2 years. Received in outpatient and inpatient facilities, evidence suggests that the incidence of invasive and non-invasive forms of pneumococcal infection was significantly lower in the vaccinated children It was revealed that the vaccination coverage against pneumococcal infection in children from 2 months to one year and the second year of life was 51 and 40% respectively. Vaccination in the first six months of life in 2016 received only 25% of children. A high proportion of the parent's refusal of vaccination of children (54.2%), and high frequency medical taps (9.7%) from vaccination.
1 ФГБОУ ВО «Пермский государственный медицинский университет им. академика Е.А. Вагнера» Минздрава России 2 ФГУП «Санкт-Петербургский НИИ вакцин и сывороток и предприятие по производству бактериальных препаратов» ФМБА России Оценка реактогенности, безопасности и иммуногенности отечественной гриппозной инактивированной расщепленной вакцины ФЛЮ-М при иммунизации взрослых в возрасте 18-60 лет Резюме В статье представлены результаты простого слепого рандомизированного плацебо-контролируемого одноцентрового проспективного исследования реактогенности, безопасности и иммуногенности отечественной гриппозной инактивированной расщепленной вакцины ФЛЮ-М при иммунизации взрослого населения в возрасте 18-60 лет. Установлена низкая реактогенность, высокий профиль безопасности и иммуногенности вакцины ФЛЮ-М. Ключевые слова: вакцина против гриппа ФЛЮ-М, взрослое население 18-60 лет, безопасность, реактогенность, иммуногенность Evaluation of the Reactogenicity, Safety and Immunogenicity of the Domestic Influenza Inactivated Split FLU-M Vaccine in Immunization Adults aged 18-60 Years I. V. Fel'dblyum 1 (irinablum@mail.ru), SAbstract This article presents the results of a simple, blind, randomized, placebo-controlled, single-center, prospective research of the reactogenicity, safety, and immunogenicity of the domestic influenza inactivated split vaccine «Flu-M» in immunization of the adult population of 18-60 years old. Low reactogenicity, high safety profile and immunogenicity of the Flu-M vaccine were determined.
The analysis of the vaccine preventive status of infectious diseases in adults in Russia and various countries of the world is presented in the article. The problems and directions of improving the immunization of the adult population in Russia are identified.
Here we present the data on foreign research publications describing healthcare-associated enteroviral (nonpolio) infections (HAI) sought in the Worldwide Database for Nosocomial Outbreaks (Institut für Hygiene und Umweltmedizin, Universitȁtmedizincomplex “Charite”, Germany) as well as PubMed search engine (The United States National Library), covering 1936–2017 timeframe. The publications retrieved contained the data on 28 nosocomial outbreaks caused by Enterovirus A (EV-A71), В (Echoviruses 11, 17, 18, 30, 31, 33, Coxsackie viruses А9, В2, В5) and D (EV-D68). It was discovered that the majority of the nosocomial enteroviral (non-polio) outbreaks occurred in obstetric hospitals and neonatal units so that children were mainly maternally infected. In addition, a case associated with intrauterine infection was described. It was shown that outbreaks might be started by an infected child at the incubation period. Single publications reported nosocomial outbreaks in geriatric hospitals. Generally, nosocomial enteroviral (non-polio) outbreaks were characterized by polymorphic clinical picture caused by any certain pathogen serotype and within a single site of the infection. Few lethal outcomes were recorded. Enterovirus B species dominated among identified etiological agents. Violated hospital hygiene and infection control contributing to spread of infection were among those found in neonatal units: putting used diapers out on baby bed prior disposal, sharing bathtub, toys and household objects as well as poor hand hygiene in medical workers. One of the measures recommended to improve diagnostics of enteroviral (non-polio) infections was virology screening of children with suspected sepsis in case of unidentified etiology. It was established that etiological decoding of nosocomial outbreaks was impossible without applying pathogen-specific diagnostic tools, mainly nested RT-PCR and direct sequencing of followed by subsequent phylogenetic analysis.
The purpose of the article is to provide an analytical overview of achievements and problems of vaccination in worldwide and in Russia. Article is showing that already, elimination of measles and rubella from the Americas providing proof in principle of the feasibility of their ultimate global eradication Authors analyzed the state of vaccination affairs in Russia. It is necessary to expand the National immunization schedule of preventive vaccinations. The main problems of vaccine prevention are outlined and suggested the ways of their solution.
Detection of post-vaccination complications with the subsequent investigation of causes and measures to prevent their occurrence increases the perception of the immunization society and improves health care. This is primarily increases the immunization coverage, which leads to lower morbidity. The purpose of this article is to offer for discussion a new algorithm for the registration of diseases postvaccination period, based on a synthesis of the existing national system and modern international approaches.
At present it is impossible to develop epidemiologic surveillance and control over any infection regarding studies on dynamics of morbidity, seasonality and periodicity without using mathematical modeling techniques. Our research goal was to study regularities in manifestations of epidemic process for enterovirus (non-polio) infection (EVnI) in the Russian Federation over 14 years (2006–2019) using mathematical models (linear, logarithmic, power, and exponential approximation).An optimal mathematical model was selected using three statistical parameters, namely determination coefficient, Fischer’s exact test, and standard error. Periodicity of rises and falls in morbidity was calculated with Fourier one- dimensional spectral analysis. Intra-year dynamics of morbidity with EVnI was estimated basing on monthly spread of the disease cases on the RF territory. Classic seasonal decomposition, Census I technique, was applied to analyze time series of monthly morbidity. It was determined that EVnI epidemic process was unevenly spread over years in the RF in the examined period of time (2006–2019) and there were two opposite trends in it; the first one lasted from 2006 to 2010 when morbidity was declining and the second was from 2010 to 2019 when it was growing. Having analyzed manifestations of EVnI epidemi- ologic process in long-term dynamics given its uneven spread as per years, we established that it was advisable to use mathematical models approximated as per separate time periods. Average long-term morbidity with EVnI amounted to 8.09 0/0000 in the RF in 2010–2019 with growth rate being equal to 17.7 %. Maximum value was registered in 2017 (16.32 0/0000). An unfavorable prediction for further epidemic situation development was revealed for the examined pe- riod. The epidemic process was characterized with 4-year periodicity and summer-autumn seasonality with peaks usually occurring in August and September. Rates that characterized intensity of the trends in long-term morbidity dynamics and were calculated with mathematical models differed authentically from those obtained via conventional calculations of average values (χ=11.08; d.f.=1; p=0.0009).
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