Clinical Core

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SUMMARY The VIVA Clinical Core B provides the infrastructures needs to support standardized approaches for the recruitment, longitudinal retention and clinical characterization of human subjects enrolled in observational studies. The Core B will facilitate patient centered research through activities and services such as access to populations of people who a) were infected with SARS-CoV-2, influenza virus or dengue virus, b) received immunization(s) for SARS-CoV-2, influenza virus and dengue virus. Participant derived biological specimen and corresponding clinical information will be collected in domestic as well as international settings. The Core B will continue with longitudinal follow-up of the enrolled participants, lead recruitment of new participants with acute infections by viral pathogens of interest. It will direct the biospecimen collection, banking at the Icahn School of Medicine at Mount Sinai (ISMMS) and will ensure timely sample distribution to the three different Projects and the two other data producing Cores (Immune Phenotyping Core C and Genomics Core D) within the VIVA HIPC. Aim 1 will focus on specimens from SARS-CoV-2 studies conducted in the Mount Sinai Health System (MSHS) in NY, USA as well as from studies conducted in Buenos Aires, Argentina for Project 1. Aim 2 will focus on specimens from influenza studies conducted at the MSHS in NY, USA as well as from studies conducted in Buenos Aires, Argentina for Project 2. Aim 3 will focus on specimens from completed dengue vaccine and challenge clinical trials conducted at Johns Hopkins Bloomberg School of Public Health, MD, USA for Project 3. Aim 4 will source de-identified tonsil tissues from the Mount Sinai Hospital Biorepository in the Department of Pathology at ISMMS, NY, USA, for Project 1, Project 2 and Project 3. Aim 5 will ensure harmonization of the biological specimen collection time points and banking modalities across the different study protocols. It will support the Data Management and Analysis Core E by ensuring high quality clinical datasets are generated through implementing error- prevention strategies in the data collection across all the studies supported by Core B. Lastly, the Clinical Core will also provide regulatory support and implement appropriate human subject protection measures.