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REDS-III ZIKA Virus Research

1.   US natural history cohort of Zika virus RNA positive blood donors: This study, which is being conducted in collaboration with CDC, will enroll up to 130 blood donors found to be RNA positive for the Zika virus by the Roche assay (under Investigational New Drug) in a cohort in Puerto Rico, and probably additional cohorts in Florida and Texas. Participants will be followed at regular intervals during a period of 6 months for persistence and outcomes of Zika virus infection. The study will characterize viral and serological markers of early stages of asymptomatic  Zika virus infection; identify and store index blood components that can be further studied to characterize the performance of existing and future assays, and provide standards for assay development; study the evolution of viral markers; and establish a biorepository of blood, urine, saliva, and semen samples. It is anticipated that this study will be launched in June¬ July of 2016.

2.   Zika, Chikungunya, and Dengue incidence in Brazilian blood donors: This study will calculate the rates of blood donor viremia for Chikungunya, Dengue, and Zika viruses in Brazil between April 2016 and June 2017 at four large, geographically dispersed blood centers using a research-use only assay that is available in the US. This project will monitor the rates of viremia in donors which are a reasonable proxy of the rates of viremia in the general population for arbovirus infections. Results from this study will allow transfusion medicine experts and government officials (Brazil and US) to better evaluate which strategies to implement to enhance the safety of the blood supply vis-à-vis these three viruses.

3.   Impact of Zika and Chikungunya viruses acquisition through blood transfusion: This study, which was launched in April 2016, will 1) establish whether Zika virus is transmitted by blood in this Dengue endemic setting; 2) collect data on the relationship between viral burden and the frequency of transfusion-transmitted infection and duration of viral persistence without symptoms; and 3) assess the frequency and manifestations of clinically apparent disease in infected recipients (which may be less common than in mosquito¬ acquired infections in healthy individuals).  Pre- and post-transfusion blood samples will be collected from all transfusion recipients who agree to participate in this four-month study; these samples will be tested for the presence of Zika, Chikungunya, or Dengue viruses. This information will allow us to identify patients who did not have Zika virus before the transfusion but appear to have acquired the infection after transfusion.  For these patients, samples of the blood products they received will be retrieved and tested for the presence of Zika virus. Additionally, their clinical symptoms will be ascertained. The presence of Zika virus in the blood product that was transfused will provide evidence of a possible transfusion transmission and will trigger additional follow-up and ascertainment. Such data are critically needed to help guide donor testing and deferral strategies in endemic and non-endemic settings.

4.   Zika virus research study in chronically transfused Brazilian patients with sickle cell disease: The purpose of this study is to evaluate the rate of transfusion-transmission and more generally the clinical consequences of Chikungunya, Dengue, and Zika virus infection in this chronically-transfused population. The consequences of Zika virus infection in patients with sickle cell disease are unknown at this time. It is anticipated that this study will be launched in early 2017.

5.   Characterization of blood transfusion-transmission of Zika virus in macaques: The purpose of this study, which is under consideration, is to support non-human primate studies designed to understand the transfusion-transmissibility, viral dynamics, and efficacy of pathogen-inactivation technologies to reduce transfusion-transmissibility of Zika virus. Zika virus was first isolated in 1947 from a caged sentinel rhesus macaque left in the Zika forest  in Uganda. Thus, macaques are an excellent surrogate for modeling Zika virus transmission in humans.  It is anticipated that this study will be launched this summer.



National Institutes of Health    Department of Health and Human Services