Background
Current influenza vaccines are strain-specific and demonstrate low vaccine efficacy against H3N2 influenza disease, especially when vaccine is mis-matched to circulating virus. The novel influenza vaccine candidate, M2SR (M2-deficient Single Replication), induces a broad, multi-effector immune response.
Methods
A phase 2 challenge study was conducted to assess efficacy of M2SR vaccine expressing HA and NA from A/Brisbane/10/2007 (H3N2, clade 1). Four weeks after vaccination subjects were challenged with antigenically distinct H3N2 virus (A/Belgium/4217/2015, clade 3C.3b), and assessed for infection and clinical symptoms.
Results
Adverse events following vaccination were mild and similar in frequency between placebo and M2SR recipients. A single dose of Bris2007 M2SR induced neutralizing antibody to the vaccine (48% of recipients) and challenge strain (27% of recipients). Overall, 54% of M2SR subjects were infected after challenge, compared to 71% of placebo subjects. The subset of M2SR subjects with a vaccine-induced microneutralization response against the challenge virus had reduced rates of infection after challenge (38% vs. 71% of placebo subjects, P=0.0505) and reduced illness.
Conclusions
Subjects with vaccine-induced neutralizing antibodies were protected against infection and illness following challenge with an antigenically distinct virus. This is the first demonstration of vaccine-induced protection against a highly drifted H3N2 challenge virus.
Objective: Thermal treatment (TT), defined as treatment using supra-physiological body temperatures (39-45 C), somewhat resembles fever in terms of temperature range, one of the first natural barriers for the body to fight exposure to external pathogens. Methods: Whole-body thermal treatment (WBTT) consists of heating up the complete body to a temperature range of 39 to 45 C. Despite the recognized therapeutic potential of hyperthermia, the broad clinical use of WBTT has been limited by safety issues related to medical devices and procedures used to achieve WBTT, in particular adequate control of the body temperature. To circumvent this, a sophisticated medical device was developed, allowing long-term temperature controlled WBTT (41.5 C for up to 8 h). Technical feasibility and tolerability of the WBTT procedure (including complete anesthesia) were tested using female Aachen minipig. Optical fiber temperature sensors inserted in multiple organs were used and demonstrated consistent monitoring and control of different organs temperature over an extended period of time. Results: Clinical evaluation of the animals before, during and after treatment revealed minor clinical parameter changes, but all of them were clinically acceptable. These changes were limited and reversible, and the animals remained healthy throughout the whole procedure and follow-up. In addition, histopathological analysis of selected key organs showed no thermal treatment-related changes. Conclusion: It was concluded that WBTT (41.5 C for up to 8 h) was well tolerated and safe in female Aachen minipigs. Altogether, data supports the safe clinical use of the WBTT medical device and protocol, enabling its implementation into human patients suffering from life-threatening diseases.
Руденко О.М., доктор наук з державного управління, професор, директор науково-дослідного інституту публічного адміністрування та менеджменту Чернігівського національного технологічного університету (м. Чернігів, Україна) ІНТЕГРАЦІЯ ЯК ФЕНОМЕН СУСПІЛЬНИХ ТРАНСФОРМАЦІЙ У статті розкриваються різні підходи до розуміння сутності поняття «інтеграція» та відображаються основні тлумачення цього терміну в науковій літературі. Ключові слова: інтеграційні процеси, інтеграція, соціосистема, трансформація.The article reveals different approaches to understanding the essence of the concept of "integration" and reflects the main interpretations of this term in the scientific literature.
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