Selection and quantification of infection endpoints for trials of vaccines against intestinal helminths
Selection and quantification of infection endpoints for trials of vaccines against intestinal helminths
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DOI：
10.1016/j.vaccine.2011.03.026
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发表时间：
2011-05-09
期刊：
影响因子：
5.5
通讯作者：
Brooker, Simon
中科院分区：
文献类型：
--
作者：
Alexander, Neal;Cundill, Bonnie;Brooker, Simon
针对人体蠕虫的疫苗正在开发中，但选择最佳的寄生虫学终点和效果措施，以评估其疗效很少受到关注。假设寄生虫计数为负二项分布，我们对三种疗效指标的统计功效进行排名：试验结束时平均寄生虫强度的比值，试验结束时感染的比值比和试验期间感染发生率的比值比。我们还使用建模方法来估计试验干预对感染力的可能影响，从而估计统计功效。我们得出的结论是：（1）最终平均寄生虫强度是后期疫苗试验的合适终点，（2）试验干预措施的大规模效应不太可能明显降低社区的感染力，因此也不太可能降低统计功效，除非结合疫苗的高功效和大部分招募的人口。(C)2011爱思唯尔有限公司保留所有权利。
Vaccines against human helminths are being developed but the choice of optimal parasitological endpoints and effect measures to assess their efficacy has received little attention. Assuming negative binomial distributions for the parasite counts, we rank the statistical power of three measures of efficacy: ratio of mean parasite intensity at the end of the trial, the odds ratio of infection at the end of the trial, and the rate ratio of incidence of infection during the trial. We also use a modelling approach to estimate the likely impact of trial interventions on the force of infection, and hence statistical power. We conclude that (1) final mean parasite intensity is a suitable endpoint for later phase vaccine trials, and (2) mass effects of trial interventions are unlikely to appreciably reduce the force of infection in the community - and hence statistical power - unless there is a combination of high vaccine efficacy and a large proportion of the population enrolled. (C) 2011 Elsevier Ltd. All rights reserved.