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.
