Approaches to quality control, preclinical and clinical studies of live recombinant viral vector vaccines

At present, there are not much data on the clinical use of live recombinant viral vector vaccines. Characteristics of new vaccines should be factored into requirements/recommendations for quality control, preclinical and clinical studies of vaccines in order to enable further risk/benefit assessment. The aim of this study was to analyse current approaches to quality control, preclinical and clinical studies of live recombinant viral vector vaccines. The paper provides an overview of the licensed live viral vector vaccines and those at various stages of clinical trials. The authors analysed Russian, European, American, and Japanese guidelines related to quality issues, preclinical and clinical studies of live viral vector vaccines. The analysis demonstrated that the regulatory requirements for live recombinant viral vector vaccines include assessment of a detailed rationale for vaccine development, including information on the choice of the vector, the origin of the heterologous antigen gene(s), elements related to the transgene(s) expression, as well as assessment of the genetic and phenotypic stability of the recombinant virus, the risk of reversion to virulence or recombination with wild type strains, the potential for virus genome integration into the host cell chromosome, the pre-existing immunity to the vector, the intensity of the immune response elicited by the vector, and the reusability of the vector. The choice and number of applicable toxicological and pharmacological models will depend on these aspects. The results of the analysis of approaches to quality control, preclinical and clinical studies of live recombinant viral vector vaccines may be used in the development of Russian regulatory guidelines harmonised with the international norms and regulations.

Facing and treating hikikomori (pathological social withdrawal)

Hikikomori is a form of pathological social withdrawal or social isolation whose essential feature is physical isolation in one's home. The 2010 Japanese guidelines define that a person must meet the following criteria to be diagnosed with hikiikomori: a) marked social isolation in one's home; b) duration of continuous social isolation of at least 6 months; c) significant functional impairment or distress associated with the social isolation. Advances in the conceptualization and treatment plan are discussed.

Developing a nursing protocol for the remote verification of an expected death

Background: Homecare nurses play an important role in end-of-life care. A protocol is needed for the remote verification of expected deaths using information and communication technologies (ICT), that is consistent with Japanese guidelines. Aim: To clarify the processes that nurses use to verify deaths and to develop a tentative nursing protocol for verifying expected deaths, using home-based ICT. Methods: Using literature and semi-structured interviews, a tentative nursing protocol was developed for verifying expected deaths using home-based ICT. Findings: To protect the dignity of patients and their families, it is important that their understanding and consent is provided for the remote verification of expected deaths. Furthermore, the up-to-date legal and ethical responsibilities of nurses should be discussed regarding the verification of a patient's death to provide the best care for the patients and families when implementing the Death Certification Using Information and Communication Technology (DCUICT). Conclusion: This suggested protocol offers a framework for a new delivery of nursing care. It provides guidance for homecare nurses organising the care processes and nursing roles of DCUICT. Further revisions to this protocol must incorporate the specific requirement for the verification of nurses.