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.
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