Quantitative real-time polymerase chain reaction for malaria diagnosis and its use in malaria vaccine clinical trials
Quantitative real-time polymerase chain reaction for malaria diagnosis and its use in malaria vaccine clinical trials
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DOI：
10.4269/ajtmh.2005.73.191
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发表时间：
2005-07-01
影响因子：
3.3
通讯作者：
Gilbert, SC
中科院分区：
文献类型：
--
作者：
Andrews, L;Andersen, RF;Gilbert, SC
对有效的疟疾疫苗的需求很高，每年有数百万人受到这种疾病的影响。全球范围内正在研究各种各样的潜在疫苗，当在临床试验中进行测试时，研究人员需要从每个接种疫苗和对照志愿者中提取尽可能多的数据。在针对寄生虫生命周期肝脏阶段的疫苗临床试验期间实时进行的定量实时聚合酶链反应（PCR）的使用，提供了比单独使用显微镜的金标准方法更多的信息，并提高了安全性和准确性。PCR可以在有经验的显微镜医生在血膜上看到寄生虫之前5天检测血液中的疟原虫，灵敏度为20个寄生虫/mL血液。迄今为止，这种PCR方法已用于在牛津的IIa期试验中跟踪137名疫苗接种者和对照志愿者，并在冈比亚的IIb期田间试验中跟踪220名志愿者样本。
The demand for an effective malaria vaccine is high, with millions of people being affected by the disease every year. A large variety of potential vaccines are under investigation worldwide, and when tested in clinical trials, researchers need to extract as much data as possible from every vaccinated and control volunteer. The use of quantitative real-time polymerase chain reaction (PCR), carried out in real-time during the clinical trials of vaccines designed to act against the liver stage of the parasite's life cycle, provides more information than the gold standard method of microscopy alone and increases both safety and accuracy. PCR can detect malaria parasites in the blood up to 5 days before experienced microscopists see parasites on blood films, with a sensitivity of 20 parasites/mL blood. This PCR method has so far been used to follow 137 vaccinee and control Volunteers in Phase IIa trials in Oxford and on 220 volunteer samples during a Phase IIb field trial in The Gambia.