# Clinical subjects and recruitment

> **NIH NIH U19** · YALE UNIVERSITY · 2024 · $197,364

## Abstract

A Core will be established to support investigations on human subjects in the three research projects. This
Clinical Subjects and Recruitment Core will provide a centralized resource for subject recruitment, screening
and enrollment. Project 1 will focus on SARS-CoV-2 vaccination in adults with autoimmune disease in the
Yale-New Haven Health system who have undergone B cell depletion therapy. While samples from primary
vaccination have already been collected, a trial of repeat SARS CoV-2 vaccination and of influenza vaccination
will be done. Project 2 recruitment will focus on recruitment of older (age ≥ 65) nursing home and senior
assisted living residents for a randomized trial of high-dose versus MF59-adjuvanted influenza vaccine, and
will also recruit young adults (age 21-39) as controls. Project 3 will recruit young adults (age 16-30) with sickle
cell disease for studies of immune dysregulation and response to the pneumococcal polysaccharide vaccine,
together with controls without sickle cell disease. The Core will also facilitate skin biopsies of the vaccination
site and regional lymph node biopsies following vaccination in a subset of participants to assess tissue
transcriptomic responses. This Core will also be responsible for ensure safety and information security for all
participants and for compliance with all regulatory measures. The Core will be responsible for maintaining and
deploying our established barcoding sample system for generation of subject numbers, tracking of samples,
and mapping to external IDs, collaborating with Core B (Data Management and Analysis), where data
management platforms are based. The Core is led by investigators with extensive experience carrying out
human immunology studies who have the necessary regulatory and clinical experience. Consequently, this
Clinical Subjects and Recruitment Core will advance the goals of this Human Immunology Project Consortium
application.

## Key facts

- **NIH application ID:** 10844540
- **Project number:** 5U19AI089992-13
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Albert C Shaw
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $197,364
- **Award type:** 5
- **Project period:** 2010-07-12 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10844540

## Citation

> US National Institutes of Health, RePORTER application 10844540, Clinical subjects and recruitment (5U19AI089992-13). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10844540. Licensed CC0.

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