# Clinical Core

> **NIH NIH U19** · LA JOLLA INSTITUTE FOR IMMUNOLOGY · 2022 · $158,760

## Abstract

PROJECT SUMMARY: Clinical Core
 The Clinical Core (CC) is an integral part of the LJI HIPC Program. The Core provides leadership and
management of all clinical samples and data. This includes ensuring all regulatory documentation is in place for
human subjects research both at LJI and at collaborators' institutions, appropriate training of personnel and
monitoring all clinical study activities of the HIPC center, managing oversight of internal and external sample
collection which includes arranging for regular shipments of samples to LJI, sample storage, clinical data
collection, oversight in our specialized donor record administrative system DoRAS, and QC of received samples.
The CC ensures that HLA typing is performed on all samples that require it, as well as ensuring it works with the
Projects, Sequencing, and Data Management and Analysis Cores to confirm sample integrity and identity
throughout the experimental and bioinformatics pipeline process.
 The overall scientific program will develop a series of immune signatures for antigen-specific T cells
responding to a diverse range of respiratory pathogens, such as SARS-CoV-2, common cold coronaviruses,
influenza, tuberculosis, pneumococcus, pertussis, and fungi (aspergillus and candida). The success of the entire
program is contingent upon successful accrual of high-quality human samples and the associated donor
information. Obtaining such samples in sufficient quantity and quality presents specific challenges, because of
the proposal's focus on comparison of T cells reactive to different respiratory pathogens, and enrollment of
individuals from several, very different, geographical locations. To address these challenges, the CC will use
well-developed and validated methods to procure samples (including PBMC, lung tissue, and BAL) from cohorts
associated with natural infection, ongoing disease, and vaccination. The cohorts to be used for this program will
be obtained from either our well-established in-house LJI Center for Clinical Investigation (CCI) or our
experienced collaborators and clinicians that have access to unique cohorts and with whom we have enjoyed
fruitful relationships over many years. We are confident in our ability to provide the necessary samples as well
as clinical and scientific input to enable the most robust and compelling studies. We will continue recruitment
and sample acquisition of already established cohorts, and access previously obtained samples in the context
of the SARS-CoV-2 project (Project 1). In addition, we have established long-standing relationships with Drs.
Dharshan DeSilva (Sri Lanka), Matt O'Shea (UK), Maria Lerm (Sweden), Cesar Ugarte (Peru), and Richard
Silver (USA) that will provide longitudinal samples from subjects with latent TB infection or who are diagnosed
with active TB, and from subjects undergoing BCG vaccination (Project 2). The CC will provide lung tissue and
bronchoalveolar lavage specimens (BAL) from patients undergoing lung surgery fo...

## Key facts

- **NIH application ID:** 10419451
- **Project number:** 2U19AI118626-08
- **Recipient organization:** LA JOLLA INSTITUTE FOR IMMUNOLOGY
- **Principal Investigator:** Pandurangan Vijayanand
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $158,760
- **Award type:** 2
- **Project period:** 2015-06-15 → 2027-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10419451

## Citation

> US National Institutes of Health, RePORTER application 10419451, Clinical Core (2U19AI118626-08). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10419451. Licensed CC0.

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