Kenya AIDS Vaccine Initiative, University of Nairobi, Nairobi, Kenya.
PLoS One. 2011 Jan 21;6(1):e14580. doi: 10.1371/journal.pone.0014580.
With the persistent challenges towards controlling the HIV epidemic, there is an ongoing need for research into HIV vaccines and drugs. Sub-Saharan African countries--worst affected by the HIV pandemic--have participated in the conduct of clinical trials for HIV vaccines. In Kenya, the Kenya AIDS Vaccine Initiative (KAVI) at the University of Nairobi has conducted HIV vaccine clinical trials since 2001.
Participants were recruited after an extensive informed consent process followed by screening to determine eligibility. Screening included an assessment of risk behavior, medical history and physical examination, and if clinically healthy, laboratory testing. In the absence of locally derived laboratory reference ranges, the ranges used in these trials were derived from populations in the West.
Two hundred eighty-one participants were screened between 2003 and 2006 for two clinical trials. Of these, 167 (59.4%) met the inclusion/exclusion criteria. Overall, laboratory abnormalities based on the non-indigenous laboratory references used were the most frequent reasons (61.4%) for ineligibility. Medical abnormalities contributed 30.7% of the total reasons for ineligibility. Based on the laboratory reference intervals now developed from East and Southern Africa, those ineligible due to laboratory abnormalities would have been 46.3%. Of the eligible participants, 18.6% declined enrollment.
Participant recruitment for HIV vaccine clinical trials is a rigorous and time-consuming exercise. Over 61% of the screening exclusions in clinically healthy people were due to laboratory abnormalities. It is essential that laboratory reference ranges generated from local populations for laboratory values be used in the conduct of clinical trials to avoid unnecessary exclusion of willing participants and to avoid over-reporting of adverse events for enrolled participants.
Protocol IAVI VRC V001 [1]. ClinicalTrials.gov NCT00124007 Protocol IAVI 010 [2](registration with ClincalTrials.gov is in progress) Protocols IAVI 002 and IAVI 004 are Phase 1 trials only mentioned in introductory paragraphs; details will not be reported. Registration was not required when they were conducted.
在持续应对艾滋病流行的挑战中，人们一直需要研究艾滋病疫苗和药物。受艾滋病大流行影响最严重的撒哈拉以南非洲国家参与了艾滋病疫苗的临床试验。在肯尼亚，内罗毕大学的肯尼亚艾滋病疫苗倡议（KAVI）自 2001 年以来一直在进行艾滋病疫苗临床试验。
在经过广泛的知情同意程序和筛选以确定资格后，参与者被招募。筛选包括评估风险行为、病史和体检，如果临床健康，则进行实验室检测。由于没有本地衍生的实验室参考范围，因此这些试验中使用的范围是从西方人群中得出的。
在 2003 年至 2006 年期间，有 281 名参与者参加了两项临床试验的筛选。其中，167 人（59.4%）符合纳入/排除标准。总体而言，基于使用的非本土实验室参考值的实验室异常是导致不合格的最常见原因（61.4%）。医疗异常占不合格总原因的 30.7%。根据现在从东非和南非开发的实验室参考区间，由于实验室异常而不合格的人数将达到 46.3%。在合格的参与者中，18.6%拒绝入组。
艾滋病毒疫苗临床试验的参与者招募是一项严格且耗时的工作。在临床健康人群中，超过 61%的筛选排除原因是实验室异常。从当地人群中生成用于实验室值的实验室参考范围对于临床试验的开展至关重要，以避免不必要地排除有意愿的参与者，并避免对入组参与者过度报告不良事件。
IAVI VRC V001 [1]。ClinicalTrials.gov NCT00124007 IAVI 010 号议定书[2]（正在向 ClinicalTrials.gov 注册）IAVI 002 号和 IAVI 004 号议定书仅在引言部分提及，为 I 期试验；详细信息将不予报告。在进行时，它们不需要注册。
