title: Reference intervals in healthy adult Ugandan blood donors and their impact on conducting international vaccine trials.
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.
  
  
  RESULTS
  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
  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.
authors.affiliation: U.S. Military HIV Research Program, Rockville, Maryland, United States of America. leller@muwrp.org
authors.forename: Leigh Anne
authors.initials: LA
authors.lastname: Eller
authors.forename: Michael A
authors.initials: MA
authors.lastname: Eller
authors.forename: Benson
authors.initials: B
authors.lastname: Ouma
authors.forename: Peter
authors.initials: P
authors.lastname: Kataaha
authors.forename: Denis
authors.initials: D
authors.lastname: Kyabaggu
authors.forename: Richard
authors.initials: R
authors.lastname: Tumusiime
authors.forename: Joseph
authors.initials: J
authors.lastname: Wandege
authors.forename: Ronald
authors.initials: R
authors.lastname: Sanya
authors.forename: Warren B
authors.initials: WB
authors.lastname: Sateren
authors.forename: Fred
authors.initials: F
authors.lastname: Wabwire-Mangen
authors.forename: Hannah
authors.initials: H
authors.lastname: Kibuuka
authors.forename: Merlin L
authors.initials: ML
authors.lastname: Robb
authors.forename: Nelson L
authors.initials: NL
authors.lastname: Michael
authors.forename: Mark S
authors.initials: MS
authors.lastname: de Souza
mesh_terms: D000293:Adolescent; D000328:Adult; D044383:Black People; D001774:Blood Chemical Analysis; D001782:Blood Donors / Q000706:statistics & numerical data*; D001800:Blood Specimen Collection; D002986:Clinical Trials as Topic; D005260:Female; D006262:Health; D006405:Hematology; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D014454:Uganda; D014612:Vaccines / Q000276:immunology*
chemical_list: D014612:Vaccines