ROTAVIRUS VACCINE DEVELOPMENT IN INDIA

该资助项下的活动将是准备合作协议申请，并开始候选轮状病毒疫苗临床试验的准备工作，这是更大研究计划提案的一个组成部分，其总体目标是开发基于印度新生儿毒株116 E和L321的口服轮状病毒活疫苗。 将由该赠款开发的合作协议将支持整个项目的临床试验部分。在申请准备过程中，将开发详细研究资助申请所需的信息，并编写临床方案，以确定美国生产的两种菌株批次的安全性，免疫原性和最佳剂量和时间表。筹备工作将包括以下内容：田间试验中心和研究人群的选择和详细描述，包括人口普查和医疗服务来源的确定，在研究中心建立一个临床中心，作为临床研究的中心，包括监测不良反应，建立研究中心和全印度医学研究所之间的交通工具，第三医疗转诊医院;建立和规范免疫原性和病毒脱落的检测方法;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临床实践进行。

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.