Baseline Morbidity in 2,990 Adult African Volunteers Recruited to Characterize Laboratory Reference Intervals for Future HIV Vaccine Clinical Trials
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Date
2008-04Author
Stevens, Wendy
Kamali, Anatoli
Karita, Etienne
Anzala, Omu
Sanders, Eduard J.
Jaoko, Walter
Kaleebu, Pontiano
Mulenga, Joseph
Dally, Len
Fast, Pat
Gilmour, Jill
Farah, Bashir
Josephine, Josephine
Hughes, Peter
Manigart, Olivier
Stevens, Gwynn
Yates, Sarah
Thomson, Helen
Lieven, Andrea von
Krebs, Marietta
Price, Matt A.
Stoll-Johnson, Lisa
Ketter, Nzeera
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ArticleLanguage
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Background: An understanding of the health of potential volunteers in Africa is essential for the safe and efficient conduct
of clinical trials, particularly for trials of preventive technologies such as vaccines that enroll healthy individuals. Clinical
safety laboratory values used for screening, enrolment and follow-up of African clinical trial volunteers have largely been
based on values derived from industrialized countries in Europe and North America. This report describes baseline morbidity
during recruitment for a multi-center, African laboratory reference intervals study.
Methods: Asymptomatic persons, aged 18–60 years, were invited to participate in a cross-sectional study at seven sites
(Kigali, Rwanda; Masaka and Entebbe, Uganda; Kangemi, Kenyatta National Hospital and Kilifi, Kenya; and Lusaka, Zambia).
Gender equivalency was by design. Individuals who were acutely ill, pregnant, menstruating, or had significant clinical
findings were not enrolled. Each volunteer provided blood for hematology, immunology, and biochemistry parameters and
urine for urinalysis. Enrolled volunteers were excluded if found to be positive for HIV, syphilis or Hepatitis B and C.
Laboratory assays were conducted under Good Clinical Laboratory Practices (GCLP).
Results and Conclusions: Of the 2990 volunteers who were screened, 2387 (80%) were enrolled, and 2107 (71%) were
included in the analysis (52% men, 48% women). Major reasons for screening out volunteers included abnormal findings on
physical examination (228/603, 38%), significant medical history (76, 13%) and inability to complete the informed consent
process (73, 13%). Once enrolled, principle reasons for exclusion from analysis included detection of Hepatitis B surface
antigen (106/280, 38%) and antibodies against Hepatitis C (95, 34%). This is the first large scale, multi-site study conducted
to the standards of GCLP to describe African laboratory reference intervals applicable to potential volunteers in clinical trials.
Approximately one-third of all potential volunteers screened were not eligible for analysis; the majority were excluded for
medical reasons.
Citation
PLoS ONE 3(4): e2043Collections
- Faculty of Health Sciences (FHS) [10378]