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|Title: ||Reference intervals in healthy adult Ugandan blood donors and their impact on conducting international vaccine trials|
|Authors: ||Eller, Leigh Anne|
Eller, Michael A.
Sateren, Warren B.
Robb, Merlin L.
Michael, Nelson L.
de Souza, Mark S.
|Keywords: ||Blood donors|
|Issue Date: ||2008 |
|Publisher: ||Public Library of Science|
|Citation: ||Eller, L.A., Eller, M.A., Ouma, B., Kataaha, P., Kyabaggu, D., Tumusiime, R., Wandege, J., Sanya, R., Sateren, W.B., Wabwire-Mangen, F., Kibuuka, H., Robb, M.L., Michael, N.L., de Souza, M.S. (2008). Reference intervals in healthy adult Ugandan blood donors and their impact on conducting international vaccine trials. PLoS ONE, 3(12)|
|Abstract: ||Background: Clinical trials are increasingly being conducted internationally. In order to ensure enrollment of healthy
participants and proper safety evaluation of vaccine candidates, established reference intervals for clinical tests are required
in the target population.
Methodology/Principal Findings: We report a reference range study conducted in Ugandan adult blood bank donors
establishing reference intervals for hematology and clinical chemistry parameters. Several differences were observed when
compared to previously established values from the United States, most notably in neutrophils and eosinophils.
Conclusions/Significance: In a recently conducted vaccine trial in Uganda, 31 percent (n = 69) of volunteers screened
(n = 223) were excluded due to hematologic abnormalities. If local reference ranges had been employed, 83% of those
screened out due to these abnormalities could have been included in the study, drastically reducing workload and cost
associated with the screening process. In addition, toxicity tables used in vaccine and drug trial safety evaluations may need
adjustment as some clinical reference ranges determined in this study overlap with grade 1 and grade 2 adverse events.|
|Appears in Collections:||Research Articles (Health-Sciences)|
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