The hypotheses and aims that have been described in Projects 1, 2 and 3 of this proposal involved studying immune responses of both young infants who may or may not have been infected with human cytomegalovirus (HCMV) and control adults who have been infected with HCMV in the past. Because the various immunologic assays proposed in the individual projects will be correlated with virologic aspects of various immunologic assays proposed in the individual projects will be correlated with virologic aspects of infection, and individual blood specimens will be divided among the Principal Investigators of each project, infection, and individual blood specimens will be divided among the Principal Investigators of each project, we are proposing this Clinical Research Support Core to recruit subjects in a timely manner, assure that subjects' rights are respected, administer the protocol, provider long-term follow- up with subjects, provide centralized sample processing of blood specimens, perform the virologic studies (buffycoat and urine PCR), perform the latex fixation and neutralization assays, and maintain a centralized database of clinical and laboratory results for analysis. To aid in recruitment of potentially interested subjects, we have established collaborations with local child care centers. The laboratory of the Clinical Research Core will perform assays to identify both HCMV-infected and uninfected infants, using qualitative PCR of urine samples and HCMV- infected adults, using latex fixation. For the detection of new HCMV infection of infants, monthly urine samples will be monitored by qualitative PCR to detect onset of virus shedding. When that occurs blood samples will be monitored by qualitative PCR to detect onset of virus shedding. When that occurs, blood samples will be monitored by qualitative PCR to detect onset of virus shedding. When that occurs, blood samples will be requested as soon as possible to examine acute immune response, at 6 months to look at established immune responses, and when virus shedding ceases to correlate developed responses with control of virus infection. HCMV-positive subjects will have at least two blood samples taken and quarterly urine samples for quantitative PCR. Blood samples will be processed and aliquoted according to an algorithm for distribution to the Project PIs. A centralized database will be developed to capture clinical and assay information for analysis. This Core will allow for clinical study of the subjects, the most efficient utilization of small pediatric-sized blood samples and analysis of the combined data generated from the clinical study. As part of the research team, we will interact with all Principal Investigators to achieve the program goals.
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