# Clinical Core

> **NIH NIH U19** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2022 · $283,217

## Abstract

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.

## Key facts

- **NIH application ID:** 10435233
- **Project number:** 1U19AI168631-01
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** Viviana A Simon
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $283,217
- **Award type:** 1
- **Project period:** 2022-03-22 → 2027-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10435233

## Citation

> US National Institutes of Health, RePORTER application 10435233, Clinical Core (1U19AI168631-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10435233. Licensed CC0.

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