Reference intervals in healthy adult Ugandan blood donors and their impact on conducting international vaccine trials.
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.
Eller
Leigh Anne
LA
U.S. Military HIV Research Program, Rockville, Maryland, United States of America. leller@muwrp.org
Eller
Michael A
MA
Ouma
Benson
B
Kataaha
Peter
P
Kyabaggu
Denis
D
Tumusiime
Richard
R
Wandege
Joseph
J
Sanya
Ronald
R
Sateren
Warren B
WB
Wabwire-Mangen
Fred
F
Kibuuka
Hannah
H
Robb
Merlin L
ML
Michael
Nelson L
NL
de Souza
Mark S
MS
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*
D014612:Vaccines