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Development/production of seasonal and pandemic influenza DNA vaccines

Development/production of seasonal and pandemic influenza DNA vaccines
季节性和大流行性流感 DNA 疫苗的开发/生产
批准号：
7969867
负责人：
Richard Schwartz
金额：
$223.32万
依托单位：
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
依托单位国家：
美国
项目类别：
财政年份：
--
资助国家：
美国
项目状态：
未结题
起止时间：
至
来源：
https://reporter.nih.gov/project-details/7969867
关键词：
AnimalsClinicClinicalClinical TrialsContractsDNA VaccinesDevelopmentHumanInfluenzaLaboratoriesPhasePhase I Clinical TrialsPlacebosPlantsProductionProgram DevelopmentSerotypingTechniquesTestingTreatment ProtocolsVaccine ProductionVaccinesclinical materialinfluenza virus vaccinemanufacturing processpandemic influenzaplasmid DNApre-clinicalpreclinical safetyprogramssafety studysafety testing

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中文摘要
翻译
生产用于人类临床试验的季节性候选质粒DNA疫苗。预计这些疫苗将在I期试验中单独在人类中或作为初次加强方案的一部分进行安全性和有效性测试。如果发现是安全的，这些疫苗可能会在高级临床开发项目中进行测试。目前正在按照现行药品生产质量管理规范（cGMP）生产、灌装和放行几种不同血清型的流感疫苗，并将在临床前（动物）攻毒有效性研究中进行检测。
英文摘要
Production of seasonal candidate plasmid DNA vaccines for use in human clinical trials. It is expected that these vaccines will be tested for safety and efficacy in Phase I trials in humans alone or as part of prime boost regimens. If found to be safe, these vaccines may proceed to testing in advanced clinical development programs. Several different serotypes of influenza vaccines are being manufactured, filled and released in compliance with current Good Manufacturing Practices (cGMP) that will be tested in preclinical (animal) challenge-efficacy studies.
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