The objectives of the National Heart, Lung, and Blood Institute (NHLBI) Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program are to ensure safe and effective blood banking and transfusion medicine practices through a comprehensive, multifaceted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks. The REDS Programs have proven to be the premier research programs in blood collection and transfusion safety in the United States and well as countries seriously affected by the AIDS epidemic, many of which face critical blood safety and supply challenges.
The Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) US natural history cohort of Zika virus RNA positive blood donors will provide detailed characterization of viral dynamics and immune parameters in Zika infections based on follow-up of blood donors screened positive for Zika virus infection. These findings will inform diagnostic testing recommendations and donor screening and deferral policies to CDC and FDA. A major finding is that the Zika Virus (ZIKV) appears to remain associated with red blood cells (RBCs) and persists for months following clearance of plasma ZIKV-RNA. This has become a particular focus of ongoing research given the possible transfusion risk of ZIKV-positive RBC containing products that would be missed by current plasma based ZIKV RNA screening. The detection of persistent RBC-associated ZIKV also has major implications for diagnostic and monitoring assays. In the second year of enrollment donors and participants are monitored for reinfection, which would have significant implications for risk of recurrent epidemics, monitoring pregnancy and vaccine efficacy. In addition, clinical outcomes are correlated with viral and immune parameters in Zika infected donors to gain insights into the pathogenesis of ZIKV disease. In addition longitudinally collected samples from infected donors are distributed to CDC, FDA and NIAID as well as other academic and commercial assay developers to advance the development of critically needed Zika specific assays for ZIKV clinical diagnostic and monitoring applications.
As the Central Laboratory for REDS-III, VRI (formerly named Blood Systems Research Institute) participates in development and design of domestic and international laboratory-related studies with NHLBI and the Data Coordinating Center (DCC). The Central Lab develops detailed study protocols and laboratory operational manuals and procedures. The Central Lab manages biospecimens from Domestic and International Sites and maintains the REDS-III Biospecimen Repository at VRI, and manages all aspects of biospecimen handling. The Central Laboratory uses it’s broad range of expertise and experience to execute both small and large projects, with documented ability to simultaneously manage multiple, complex laboratory studies. Laboratory studies are conducted to enhance understanding of the epidemiology or natural history of infectious agents such as characterizing the dynamics and pathogenesis of early infection to help predict the reduction in infectious disease transfusion-transmission risk if a new or improved assay is implemented. REDS-III conducts conduct a large number of studies focused on transfusion recipients in order to understand the frequency and mechanisms underlying the therapeutic efficacy and complications of allogeneic transfusions.