BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Творчество Льва Александровича Тарасевича в области иммунологии и вакцинологии. К 150-летию со дня рождения
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Эффективность и безопасность нового препарата для лечения рассеянного склероза «пегилированный интерферон бета-1а человека» на обезьянах в сравнении с немодифицированным интерфероном бета-1а
No full textThe article presents the results of studies on the safety and efficacy of long-acting drug for the treatment of multiple sclerosis on the basis of recombinant human interferon beta-1a «PEGylated interferon beta-1a Human» (PEG IFN beta-1a) in monkeys Macaca mulatta in subcutaneous and intramuscular injection. The following doses were used: the maximum tolerated dose - 3.0·106 IU/kg, the intermediate dose - 1.5·106 IU/kg and the minimum dose, which was equivalent to human therapeutic dose of unmodified interferon beta-1a - 0.3·106 IU/kg. Quantify the parameters of pharmacodynamics of the PEG IFN beta-1a after single subcutaneous and intramuscular administration of increasing doses of different groups of monkeys. Evaluated the level and nature of the pathological changes of internal organs (visceral systems) of experimental animals caused by repeated subcutaneous and intramuscular injections of PEG IFN-beta 1a. Based on these studies the drug PEG IFN beta-1a in rhesus monkeys indicated that the drug is efficient (both in single subcutaneous and intramuscular administration) and does not have toxic effects (both in multiple subcutaneous and intramuscular administration) when using a therapeutic dose 0.3·106 IU/kg.106 МЕ/кг, промежуточная доза - 1,5·106 МЕ/кг и минимальная доза, эквивалентная терапевтической для человека немодифицированного интерферона бета-1а - 0,3·106 МЕ/кг. Проводилась количественная оценка фармакодинамических параметров препарата ПЭГ ИФН бета-1а при однократном подкожном и внутримышечном введении. Оценивались уровень и характер патологических изменений внутренних органов (систем внутренних органов) экспериментальных животных, вызванных многократными подкожными и внутримышечными введениями ПЭГ ИФН бета-1а. На основании данных исследований препарата ПЭГ ИФН бета-1а на макаках резус показано, что препарат эффективен (как при однократном подкожном, так и при однократном внутримышечном введении) и не оказывает токсического действия (как при многократном подкожном, так и при многократном внутримышечном введении) при использовании в предполагаемой терапевтической дозе 0,3·106 МЕ/кг
Оценка подлинности и стабильности вакцины БЦЖ методом мультиплексной ПЦР
No full textMultiplex polymerase chain reaction method was used to assess the stability of 7 seed lots of a substrain Mycobacterium bovis BCG-1, Russia, used for the manufacture of BCG vaccine since 1948 till present. For performng PCR we used primers, matching 5 parts of the RD field and 1part of repeating elements of intergenic operon senX3-regX3 region. Electrophoregrams of amplification products for 7 seed lots of products were identical and differed from the electrophoregrams of other known BCG substrains used as control samples. Similar results were obtained for genotyping of 32 commercial lots of BCG vaccine, manufactured using substrain M. bovis BCG-1 by three Russian manufacturers. The obtained data confirmed the stability of seed lots of BCG vaccine used for more than 60 years, and the adequacy of the settled system of strain maintanance. The assessed method of multiplex PCR with domestic reagents can accepted for confirming that the seed and the vaccine are identical to domestic BCG vaccine substrain (M. bovis BCG-1) when performing «Identification» test. The mehod is adequate and reproducible
Безопасность биологических препаратов. Сообщение 1. Вопросы терминологии и классификации
No full textAdverse drug reactions (ADR) are injuries caused by taking a medication. For the purpose of an objective analysis of the reasons and mechanisms of ADR, with a view to developing the methods for their relief and prevention, one should use standard criteria for the characterization of ADR. Typically, the description of ADR includes information about the damaged organ or tissue and the frequency of ADR occurrence. To characterize ADRs caused by low molecular weight chemicals proposed, an A/B classification and its modifications have been proposed, based on the possible mechanisms of ADR. Biological preparations differ from chemicals by a number of characteristics, including the mechanism of action. Considering the nature of biological/biotechnological preparations, several types of ADR classifications, related to the mentioned drug group, have been suggested. The most popular classification for ADR related to biological preparations have been suggested by W. J. Pichler. It is based on the involvement of immunological mechanisms in ADR occurrence. This classification divides ADR related to biologicals into 5 types: type α (reactions caused by high level of cytokines), type β (hypersensitivity reaction), type γ (reactions caused by the imbalance of immune factors), type δ (cross-reactivity reactions) and type ε (reactions caused by non-immunological mechanisms). The mentioned classification method has certain disadvantages: it does not cover all biological preparations, but only drugs, containing cytokines, hormones and monoclonal antibodies preparations; and it does not consider ADR occurring without immune mechanisms (such as increased blood pressure when administering preparations of recombinant erythropoietins)
Использование масс-спектрометрии в стандартизации препаратов аллергенов
No full textThe present article highlights the issues of standardization of diagnostic and therapeutic allergen extracts used for allergen-specific immunotherapy (ASIT) in Russia and abroad. Quality evaluation methods for finished immunobiologicals (allergens) in accordance with the regulatory documents and using biological, immunochemical and advanced physical and chemical analytical techniques (in vitro and in vivo diagnosis) have been considered. Basic standardization strategies for allergenic preparations (determination of total allergenic activity, biological activity, the content of major allergens) have been presented. Two systems of allergen standardization (allergen units and biological units) have been introduced. The potential for use of high-performance liquid chromatography combined with mass spectrometry (HPLC-MS) as the most promising method for the standardization of allergen extracts has been considered. The advantages and disadvantages of the mentioned method for the standardization of allergens has been described. The method of chromatographic analysis of the total extract of drooping birch pollen, developed by the experts of the Chair of Pharmaceutical and Toxicological Chemistry of the I. M. Sechenov First Moscow State Medical University, has been given as an example
Туберкулезная вакцина БЦЖ: иммунологическая и клиническая эффективность у детей, рожденных от женщин с ВИЧ-инфекцией
Get PDFThe article analyses the efficacy of vaccination and its influence on the nature of tuberculosis process in children perinatally exposed to HIV. The study analysed hospital records, hospital discharge summaries and outpatient medical records of children under 14 with tuberculosis: there were 109 HIV-infected children and 97 children perinatally exposed to HIV (but not HIV-infected). The postvaccinal immunity status was assessed by the presence and size of the vaccination scar and the response to the Mantoux test. The clinical efficacy of the BCG vaccination was assessed by the severity of tuberculosis in vaccinated and non-vaccinated children. It was shown that immunization with BCG vaccine (BCG-M) was safe and efficacious in children born to HIV-infected women but not infected with HIV. At the same time the vaccine did not demonstrate sufficient immunological and clinical efficacy in HIV-infected children: the response to the Mantoux test, 2 TU, was positive only in one third of all vaccinated children; there was no statistically significant difference in the frequency of disseminated processes in vaccinated children as compared to the non-vaccinated children perinatally exposed to HIV. A conclusion was made that children born to HIV-infected mothers but not infected with HIV must be vaccinated during the neonatal period. The vaccination of HIV- infected children is not advisable due to its low clinical efficacy and the risk of development of disseminated complications, for instance, the generalized BCG infection in HIV-infected children may develop over a period of 3 years after vaccination
Гемофильная инфекция типа b. Заболеваемость и вакцинопрофилактика
No full textThe article summarizes the existing knowledge on the infection caused by Haemophilus influenzaetypeb (Hib-infection). It examines clinical immunology aspects of vaccination against Hib-infection. The authors cite data on the incidence of invasive Hib-infections in the Russia and other countries. Special attention is given to preventive vaccination against Hib-infection. The article describes properties of polysaccharide and conjugate vaccines against Hib-infection and examines different immunization schedules, therapeutic indications and contraindications, potential adverse reactions, and the vaccination procedure.В статье изложены современные представления об инфекции, вызываемой Haemophilus influenzae типа b (Hib-инфекция). Рассмотрены клинико-иммунологические особенности вакцинации против Hib-инфекции. Представлены данные о заболеваемости инвазивными формами Hib-инфекции в Российской Федерации и в разных странах мира. Особое внимание уделено вакцинопрофилактике Hib-инфекции. Дана характеристика полисахаридных и конъюгированных Hib-вакцин. Рассмотрены различные схемы иммунизации, медицинские показания и противопоказания к применению, возможные побочные реакции, а также порядок проведения вакцинации
Процедура обновления штамма вакцины против гриппа в странах ЕС. Вопросы качества
No full textIn 2009-2010 there was an influenza pandemic that occurred despite all preventive measures. Analysis of this pandemic revealed some gaps in the regulatory requirements applied both to the development of new influenza vaccines and to the change/update of the seasonal influenza vaccine strains. Taking into account the lessons learned from this pandemic the European Medicines Agency revised the existing guidelines in 2014-2016 and proposed new recommendations on quality evaluation and conduct of non-clinical and clinical trials in the development of influenza vaccines. The revised requirements encompass not only quality evaluation issues, but also changes/update of strain composition of seasonal, pre-pandemic and pandemic influenza vaccines. The experience acquired by the Agency can help update the Russian regulatory framework in order to improve efficacy and safety of influenza vaccines.Несмотря на регулярно проводимые профилактические мероприятия, в 2009-2010 годах произошло развитие пандемии гриппа. Анализ опыта пандемии выявил недостатки регуляторных требований, касающихся как разработки новых вакцин против гриппа, так и процедуры замены/обновления сезонных штаммов вакцин против гриппа. Учитывая опыт пандемии гриппа, Европейским медицинским агентством по лекарственным средствам (ЕМА) в 2014-2016 годах были обновлены уже имеющиеся и разработаны новые рекомендации по оценке качества, проведению доклинических и клинических исследований при разработке вакцин против гриппа. Обновленные требования касаются не только вопросов оценки качества, но и процедуры замены/обновления актуальных штаммов сезонных, препандемических и пандемических вакцин против гриппа. Опыт, накопленный ЕМА, может быть полезен при подготовке отечественной нормативной базы, необходимой для повышения эффективности и безопасности вакцин против гриппа
