EVALUATION OF TWO NEW CHANNENGE POOLS OF NORWALK VIRUS INOCULA IN HUMAN SUBJE

Norwalk 病毒接种物的两个新通道池在人体中的评价

• 批准号: 8356761
• 负责人: DAVID Y GRAHAM
• 金额: $ 3.76万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356761
• 关键词: Adverse event; Clinical; Clinical Research; Development; Dose; Evaluation; Funding; Future; Gastroenteritis; Grant; Human; Infection; National Center for Research Resources; Norwalk virus; Principal Investigator; Regimen; Reporting; Research; Research Infrastructure; Resources; Reverse Transcriptase Polymerase Chain Reaction; Source; United States National Institutes of Health; Work; blind; cost; vaccine candidate

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.

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 子项目的主要研究者可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 未报告非预期问题或不良事件。很明显，诺瓦克病毒的ID 50极低，4.8个RT-PCR单位是未来候选疫苗开发工作的正确剂量。我们对最后一组研究的方案（n=5）仍然是盲态的，但只有一例发生了轻度的短期胃肠炎，并在一天内消退。另一个有亚临床感染。我们只能假设0.48个RT-PCR单位太低，不足以引起感染。