CoVPN LOC Cross-Protocol Infrastructure Supplement for GY15 and GY16

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NOSI: NOT-AI-20-034 FOA: PA-20-135 – Emergency Competitive Revision to Existing NIH Awards Activity Code/Award: UM1/A1068614-15 (parent award) ------------------------------------------------------------------------------------ Project 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 continue work begun in several COVID-19 vaccine efficacy trials, perform necessary bridging studies for select populations, and continue to study the immunological effects of SARS- CoV-2 in an evolving epidemic landscape. Due to its experience in implementation of global HIV vaccine efficacy trials and its operational capacity to respond to a new global pandemic, the HVTN has been chosen as the vaccine operations center for the newly constituted COVID-19 Prevention Network (CoVPN). Continuing work begun in the spring of 2020 in a series of large scale efficacy trials, this proposal outlines four specific aims required to support the infrastructural capacity to continue this work over the coming months: to support the CoVPN vaccine operations center for implementation and management of COVID-19 vaccine phase 3 efficacy and bridging trials, to rapidly publish trial data, to build external relations networks in high-risk groups, and to work with media outlets to advertise and promote ongoing enrollment. This proposal will ensure that 74 clinical trials sites in the United States and over 50 trial sites in Latin America and Sub-Saharan Africa are fully support in continuing implementation of NIH supported COVID-19 vaccine efficacy trials and bridging studies planned for implementation over the next year.