The objective of this Cooperative Center for Translational Research on Human Immunology andBiodefense is to use analysis of vaccine-induced and naturally acquired immunity to influenza A as amodel for defining adaptive and innate immune mechanisms and antiviral protection in children andadults. The Clinical Research Core will be responsible for coordinating protocol design andimplementation, providing biostatistical support, obtaining human subjects approvals, and creating andmanaging the centralized database to record clinical and laboratory data. The Clinical Research Corewill include a laboratory to receive blood and respiratory specimens, carry out initial sample processingand to distribute relevant specimens to the participating laboratories, perform serology assays andrapid diagnostic tests for influenza A infection, and archive and store selected specimens for futureanalyses. Centralizing these functions is particularly important to assure the most efficient use of smallvolume pediatric blood samples. As the work proceeds, the Core database will facilitate comparativeanalyses of results obtained from the individual Research Projects.
The Specific Aims are Aim 1: Todesign the clinical study and data analysis plan, make the necessary IRB submissions for clinicalstudies, recruit and enroll adults and children into clinical protocols, assure that subject rights arerespected, and provide follow-up to assure collection of complete sets of data.
Aim 2 ' To provide initialsample processing and distribution of blood or saliva samples to the Principal Investigators, performstandard serologic assays to determine baseline influenza A immune status and measure antibodyresponses to vaccination or natural infection. The Core will also perform direct influenza A rapiddiagnostic tests to recruit children for study of natural influenza A infection. Respiratory samples from asubset of children in the vaccine study will be collected weekly by Core personnel during the fluseason.
Aim 3 ' To provide centralized data management and biostatistical support for the Center. TheClinical Research Support Core will thus administer the clinical protocols under which samples arecollected for use in all Research Projects and Research Resource Technical Development Projects.
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