A primary challenge in performing human immunology studies is the procurement of relevant patient samples. Accordingly, to obtain samples that are sterile, viable, and in sufficient quantity and quality is a significant task. Our Program proposal is especially ambitious as it focuses on comparison of two different diseases (DENV and MTB), different disease or exposure states, and to ensure the generality of results, enrolls individuals from several, very different, geographical locations. To address these challenges, our Clinical Core will use well- developed and validated methods to procure PBMC from sufficiently powered cohorts associated with natural infection, current disease, and vaccination to both DENV and MTB and employs our best and most experienced collaborators and clinicians with whom we have enjoyed fruitful relationships over the last 6 years. The Clinical Core will provide a centralized resource for accrual of human PBMC and sera/plasma samples, and ensure the quality and uniformity of handling of the samples received. These functions are crucial to provide a strong foundation for the studies described in the three proposed projects. The Clinical Core will work closely with the Administrative Core, the individual Projects, and the various clinical subcontractors to enable success of all objectives in this program proposal. This Core will be specifically responsible for the preparation and maintenance of IRB protocols, oversight of subject recruitment, quality control of anonymized clinical information and donor samples, and HLA typing of donor samples.
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