Reference intervals in healthy adult Ugandan blood donors and their impact on conducting international vaccine trials
U.S. Military HIV Research Program, Rockville, MD, United States; Makerere University Walter Reed Project, Kampala, Uganda; Uganda National Blood Transfusion Service, Kampala, Uganda; Walter Reed Army Institute of Research, Rockville, MD, United States; Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand
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.
carbon dioxide; hemoglobin; vaccine; article; blood donor; blood sampling; clinical chemistry; controlled study; drug safety; eosinophil; female; hematology; human; human experiment; male; mass screening; neutrophil count; normal human; reference value; screening test; thrombocyte count; Uganda; United States; volunteer; adolescent; adult; blood analysis; clinical trial; health; immunology; international cooperation; middle aged; Negro; statistics; Adolescent; Adult; African Continental Ancestry Group; Blood Chemical Analysis; Blood Donors; Blood Specimen Collection; Clinical Trials as Topic; Female; Health; Hematology; Humans; International Cooperation; Male; Middle Aged; Reference Values; Uganda; Vaccines