RESUMO
Recombinant viral vaccines expressing antigens of pathogenic microbes (e.g., HIV, Ebola virus, and malaria) have been designed to overcome the insufficient immune responses induced by the conventional vaccines. Our knowledge of and clinical experience with the new recombinant viral vaccines are insufficient, and a clear regulatory pathway is needed for the further development and evaluation of recombinant viral vaccines. In 2018, the research group supported by the Ministry of Health, Labour and Welfare, Japan (MHLW) published a concept paper to address the development of recombinant viral vaccines against infectious diseases. Herein we summarize the concept paper-which explains the Japanese regulatory concerns about recombinant viral vaccines-and provide a focus of discussion about the development of recombinant viral vaccines.
Assuntos
Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Vacinas Sintéticas/normas , Vacinas Virais/normas , Animais , Anticoncepcionais Masculinos/farmacologia , Modelos Animais de Doenças , Avaliação Pré-Clínica de Medicamentos , Humanos , Hospedeiro Imunocomprometido , Japão , Microrganismos Geneticamente Modificados , Controle de Qualidade , Distribuição Tecidual , Vacinas Sintéticas/farmacologia , Vacinas Virais/farmacocinética , Replicação Viral/fisiologia , Eliminação de Partículas ViraisRESUMO
We compared the antimicrobial susceptibility of Mycoplasma pneumoniae isolates from pediatric patients in Japan in 2011-2012 and 2015-2016, when epidemics occurred. The antimicrobial activity of macrolides and tetracyclines against M. pneumoniae infection tended to be restored in 2015-2016. There was no change in the antimicrobial activity of quinolones against M. pneumoniae infection.
Assuntos
Anti-Infecciosos/uso terapêutico , Mycoplasma pneumoniae/efeitos dos fármacos , Pneumonia por Mycoplasma/tratamento farmacológico , Criança , Epidemias , Humanos , Japão/epidemiologia , Macrolídeos/uso terapêutico , Testes de Sensibilidade Microbiana/métodos , Mycoplasma pneumoniae/isolamento & purificação , Pneumonia por Mycoplasma/epidemiologia , Pneumonia por Mycoplasma/microbiologia , Tetraciclinas/uso terapêuticoRESUMO
We evaluated isolates obtained from children with Mycoplasma pneumoniae infection throughout Japan during 2008-2015. The highest prevalence of macrolide-resistant M. pneumoniae was 81.6% in 2012, followed by 59.3% in 2014 and 43.6% in 2015. The prevalence of macrolide-resistant M. pneumoniae among children in Japan has decreased.
Assuntos
Farmacorresistência Bacteriana/genética , Macrolídeos/uso terapêutico , Mycoplasma pneumoniae/genética , Pneumonia por Mycoplasma/tratamento farmacológico , Pneumonia por Mycoplasma/epidemiologia , RNA Ribossômico 23S/genética , Adolescente , Antibacterianos/uso terapêutico , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Japão/epidemiologia , Masculino , Testes de Sensibilidade Microbiana , Taxa de Mutação , Mycoplasma pneumoniae/classificação , Mycoplasma pneumoniae/efeitos dos fármacos , Mycoplasma pneumoniae/isolamento & purificação , Pneumonia por Mycoplasma/microbiologia , PrevalênciaRESUMO
This is the first report of penicillin/cephalosporin-resistant Helicobacter cinaedi arising from prolonged treatment. H. cinaedi, common among immunocompromised patients, caused recurrent bacteremia and cellulitis in a 19-year-old Japanese man with X-linked agammaglobulinemia. The minimal inhibitory concentration of these drugs was raised, which subsequently resulted in clinical failure. Prolonged suboptimal treatment may cause bacterial resistance to ß-lactam antibiotics in H. cinaedi. It is possible that this resistance may have contributed to the treatment failure.