# Data Management Core: Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

> **NIH NIH U19** · BOSTON CHILDREN'S HOSPITAL · 2021 · $2,129,888

## Abstract

IMmunoPhenotyping Assessment in a COVID-19 Cohort (IMPACC): Clinical and Data Coordinating
Center (CDCC)
Project summary
In December 2019, a cluster of respiratory illness in Wuhan, China defined the onset of a global pandemic
involving a novel coronavirus (SARS-CoV-2) with associated respiratory disease (COVID-19). There are major
research efforts underway to understand SARS-CoV-2 infections and the associated COVID-19 disease. The
IMmunoPhenotyping Assessment Covid-19 Cohort (IMPACC) surveillance study is based upon an observational
cohort that will collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling
of blood and respiratory secretions and viral shedding in nasal secretions. The goal of the surveillance study is
to identify immunophenotypic and genomic features of COVID-19-related susceptibility and/or progression.
The IMPACC Clinical and Data Coordinating Center (CDCC) will provide clinical and data coordination support
for the IMPACC study. This includes comprehensive study coordination and project management support across
all participating IMPACC clinical and Core laboratory sites, including initial site training and ongoing study support
through the completion of study enrollment and follow-up. The CDCC will provide clinical sites with real-time
sample tracking and data capture capabilities, including all necessary supplies and reagents for sample
collection, electronic case report forms (eCRFs) for data entry, and quality control/quality assurance (QC/QA)
processes to ensure high quality sample collection and data capture. Finally, the CDCC will design digital
infrastructure components to facilitate data management, data storage, and data analysis of study endpoint and
safety data, including interim and final analysis of primary endpoints, ongoing safety and outcome monitoring,
and bioinformatics analytic support for secondary/exploratory endpoints.

## Key facts

- **NIH application ID:** 10344008
- **Project number:** 3U19AI118608-05S6
- **Recipient organization:** BOSTON CHILDREN'S HOSPITAL
- **Principal Investigator:** AL OZONOFF
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $2,129,888
- **Award type:** 3
- **Project period:** 2021-02-25 → 2022-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10344008

## Citation

> US National Institutes of Health, RePORTER application 10344008, Data Management Core: Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity (3U19AI118608-05S6). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10344008. Licensed CC0.

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