Национальный медицинский исследовательский центр фтизиопульмонологии и инфекционных заболеваний» МЗ РФ, Москва, РФ 2ГБОУ ВО «Первый Московский государственный медицинский университет им. И. М. Сеченова» МЗ РФ (Сеченовский уни верситет), Москва, РФ 3ГБУЗ «Самарский областной клинический противотуберкулезный диспансер им. Н. В. Постникова», г. Самара, РФ 4ФГБУ «ГНЦ Институт иммунологии» ФМБА России, Москва, РФ Представлен краткий обзор становления и развития системы скрининга детского населения на туберкулез и на латентную туберкулезную инфекцию-от альт-туберкулина Коха до современных рекомбинантных аллергенов туберкулезных для внутрикожного введения и ла бораторных тестов in vitro. Приведены обширные данные о клиническом исследовании и внедрении в практическое здравоохранение РФ пробы с аллергеном туберкулезным рекомбинантным в качестве скрининга на туберкулез у детей с 8 до 14 лет включительно.

BACKGROUND: TMC207-C211 (NCT02354014) is a Phase 2, open-label, multicentre, single-arm study to evaluate pharmacokinetics, safety/tolerability, antimycobacterial activity and dose selection of bedaquiline (BDQ) in children (birth to <18 years) with multidrug-resistant-TB (MDR-TB).METHODS: Patients received 24 weeks’ BDQ with an anti-MDR-TB background regimen (BR), followed by 96 weeks of safety follow-up. Results of the primary analysis are presented based on data up to 24 weeks for Cohort 1 (≥12–<18 years; approved adult tablet at the adult dosage) and Cohort 2 (≥5–<12 years; age-appropriate 20 mg tablet at half the adult dosage).RESULTS: Both cohorts had 15 patients, of whom respectively 53% and 40% of Cohort 1 and Cohort 2 children had confirmed/probable pulmonary MDR-TB. Most patients completed 24 weeks´ BDQ/BR treatment (Cohort 1: 93%; Cohort 2: 67%). Geometric mean BDQ area under the curve 168h values of 119,000 ng.h/mL (Cohort 1) and 118,000 ng.h/mL (Cohort 2) at Week 12 were within 60–140% (86,200–201,000 ng.h/mL) of adult target values. Few adverse event (AE) related discontinuations or serious AEs, and no QTcF >460 ms during BDQ/BR treatment or deaths occurred. Of MGIT-evaluable patients, 6/8 (75%) Cohort 1 and 3/3 (100%) Cohort 2 culture converted.CONCLUSION: In children and adolescents aged ≥5–<18 years with MDR-TB, including pre-extensively drug-resistant-TB (pre-XDR-TB) or XDR-TB, 24 weeks of BDQ provided a comparable pharmacokinetic and safety profile to adults.

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The objective of the study: to analyze certain parameters of immune status in children with complications after BCG/BCG-M vaccination.Subjects and methods. The immune status parameters were tested in 24 children who developed complications after TB vaccination such as BCG-ostitis, BCG-lymphadenitis. Lymphocyte population was assessed using flow cytofluorometry by Cytomics FC 500 (Bekman Coulter).The serum level of immunoglobulins IgG, IgA, IgM was tested by immunodiffusion in Mancini agar. The leukocyte phagocytic activity was tested using flow cytofluorometry (Cytofluorimeter Cytomics FC 500) with FITC-labeled staphylococcus.Results. Of the 24 children with BCG lymphadenitis or BCG ostitis, 22 (92%; 95% CI 73-99%) had abnormality in immune status.Of the 24 children, 7 had low CD3+ count, while 9 had an elevated level of CD3+ . The level of СD4+ was low in 4 children and elevated in 15 pediatric patients. CD8+ count was low in 21 children (88%; 95% CI 72-97%). 11 children had low СD16+ number, and it was elevated in 2 children. In 10 children, low level of СD16+ was combined with low level of CD8+ . 10 children had low СD19+ number, and it was elevated in 4 children. The leukocyte phagocytic index drastically decreased (down to 37%) only in 1 child, and in 23 children, it varied from 60 to 90%.IgG level was low in 13 (54%), and elevated in 2 (8%) children. IgA level was low in 6 (25%), and it was not detected at all in 8 (33.3%) children. IgM level was elevated in 4/24 (17%) children, while it was low in 1/24 (4%). In 8 children with no IgA detected, the IgG level was low in 5 of them, 3 had a normal level, and IgM level was elevated in 2 children, 6 children had a normal level of IgM. With IgA completely absent, 1 child had the normal level of IgG and IgM.

The article presents a brief overview of the establishment and development of screening system in the pediatric population for tuberculosis and latent tuberculosis infection - from Koch alt-tuberculin to modern recombinant tuberculosis allergens for intradermal administration and in vitro laboratory tests. It gives extensive data on clinical research and the introduction into practical public health of the Russian Federation of the test with recombinant tuberculosis allergen as a screening method for tuberculosis in children from 8 to 14 years old inclusively.