ROTAVIRUS VACCINE DEVELOPMENT IN INDIA

这笔赠款下的活动将是准备一份合作协议申请，并开始准备候选轮状病毒疫苗的临床试验，这是一个更大的研究项目提案的组成部分，该项目的总体目标是开发基于印度新生儿毒株116E和L321的口服活轮状病毒疫苗。由这笔赠款制定的合作协议将支持整个项目的临床试验部分。在准备申请时，将开发详细研究拨款申请所需的信息，并将编写临床方案，以确定在美国生产的大量这两种菌株的安全性、免疫原性、最佳剂量和时间表。筹备工作将包括以下内容：实地试验地点和研究人群的选择和详细说明，包括普查和确定医疗保健来源；在研究地点建立一个诊所，作为临床研究的中心，包括监测不良反应；在试验地点和三级保健转诊医院全印度医学科学研究所之间建立交通工具；建立免疫原性和病毒脱落分析并使之标准化；建立适当储存疫苗和临床标本的设施，使试验能够按照良好的临床做法进行。

The activities under this grant will be to prepare an application for a cooperative agreement and to begin preparatory work for clinical trials of candidate rotavirus vaccines that is an integral part of a larger research program proposal, which has the overall aim of developing a live oral rotavirus vaccine based on Indian neonatal strains 116E and L321. The cooperative agreement that will be developed by this grant will support the clinical trails component of the overall project. In preparation of the application, information will be developed that is required for the detailed research grant application, and clinical protocols will be written that are required to determine the safety, immunogenicity and optimal dosage and schedule of lots of the two strains produced in the US. Preparatory work will included the following: Selection and detailed description of the field trail site and study population, including a census and determination of sources of medical care, establish a clinical at the study site which will serve as the hub of the clinical research, including surveillance for adverse effects, establish means of transportation between the site and the All India Institute of Medical Sciences, the tertiary care referral hospital; establish and standardize assays for immunogenicity and virus shedding; and establish facilities for proper storage of vaccines and clinical specimens to enable the trail to be conducted according to good clinical practices.