EVALUATION OF TWO NEW CHANNENGE POOLS OF NORWALK VIRUS INOCULA IN HUMAN SUBJE
EVALUATION OF TWO NEW CHANNENGE POOLS OF NORWALK VIRUS INOCULA IN HUMAN SUBJE
批准号:
8356761
负责人:
DAVID Y GRAHAM
金额:
$3.76万
依托单位国家:
美国
项目类别:
财政年份:
2010
资助国家:
美国
项目状态:
已结题
起止时间:
2010-12-01 至 2011-11-30
关键词:
Adverse eventClinicalClinical ResearchDevelopmentDoseEvaluationFundingFutureGastroenteritisGrantHumanInfectionNational Center for Research ResourcesNorwalk virusPrincipal InvestigatorRegimenReportingResearchResearch InfrastructureResourcesReverse Transcriptase Polymerase Chain ReactionSourceUnited States National Institutes of HealthWorkblindcostvaccine candidate
中文摘要
这个子项目是利用资源的许多研究子项目之一。
由NIH/NCRR资助的中心拨款提供。对子项目的主要支持
子项目的首席调查员可能是由其他来源提供的,
包括美国国立卫生研究院的其他来源。为子项目列出的总成本可能
表示该子项目使用的中心基础设施的估计数量,
不是由NCRR赠款提供给次级项目或次级项目工作人员的直接资金。
没有未预料到的问题或不良事件可供报告。很明显,诺瓦克病毒的ID50非常低,4.8个RT-PCR单位是未来疫苗候选开发工作的合适剂量。我们仍然对最后一组受试者(n=5)的治疗方案视而不见,但只有一人发展为轻度休克期胃肠炎,并在一天内消退。另一名患者患有亚临床感染。我们只能假设0.48个RT-PCR单位太低,不会引起感染。
英文摘要
This subproject is one of many research subprojects utilizing the resources
provided by a Center grant funded by NIH/NCRR. Primary support for the subproject
and the subproject's principal investigator may have been provided by other sources,
including other NIH sources. The Total Cost listed for the subproject likely
represents the estimated amount of Center infrastructure utilized by the subproject,
not direct funding provided by the NCRR grant to the subproject or subproject staff.
There have been no unanticipated problems nor adverse events to report. It is clear that the ID50 for Norwalk virus is extremely low and that 4.8 RT-PCR units is the right dose for future vaccine candidate development work. We are still blind to the regimen of the last group studied (n=5), but only one developed a mild cases of shrot-term gastroenteritis that resolved within a day. Another had a sub-clinical infection. We can only assume that 0.48 RT-PCR units is too low to cause infection.
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EVALUATION OF TWO NEW CHANNENGE POOLS OF NORWALK VIRUS INOCULA IN HUMAN SUBJE
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