CoVPN Vaccine Site Preparation

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Project Summary/Abstract Given the rapid spread of SARS-CoV-2 infection, the on-going global pandemic, and the risk for seasonal recurrence there is a critical need to test emerging vaccine candidates in phase 3 efficacy trials. Due to its experience in implementation of global HIVAIDS prevention efficacy trials and its operational capacity to respond to a new global pandemic, the HPTN, in collaboration with the HVTN, is providing operational support for the newly constituted COVID-19 Prevention Network (CoVPN). Preparing for a series of large scale efficacy trials, this application outlines aims required to build the infrastructure capacity to rapidly implement them over the coming month. The requested funds are to prepare clinical trial sites for implementation of these trials. The HPTN will support 30 clinical trials sites in the United States, South America, and Sub-Saharan Africa so they can begin enrollment in NIH supported COVID-19 vaccine and monoclonal trials planned for implementation over the next 6 months.