Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, Québec, Canada.
Département de Médecine, Université de Montréal, Montréal, Québec, Canada.
Clin Infect Dis. 2023 Aug 14;77(Suppl 3):S270-S275. doi: 10.1093/cid/ciad359.
Controlled human infection model trials for hepatitis C virus represent an important opportunity to identify correlates of protective immunity against a well-characterized inoculum of hepatitis C virus and how such responses are modified by vaccination. In this article, we discuss the approach to immunological monitoring during such trials, including a set of recommendations for optimal sampling schedule and preferred immunological assays to examine the different arms of the immune response. We recommend that this approach be adapted to different trial designs. Finally, we discuss how these studies can provide surrogate predictors of the success of candidate vaccines.
用于丙型肝炎病毒的人体感染控制模型试验代表了一个重要的机会,可以确定针对丙型肝炎病毒的特征性接种物的保护性免疫相关因素,以及这种反应如何通过疫苗接种来改变。在本文中,我们讨论了在这种试验中进行免疫监测的方法,包括一套最佳采样计划和首选免疫测定的建议,以检查免疫反应的不同方面。我们建议根据不同的试验设计来调整这种方法。最后,我们讨论了这些研究如何为候选疫苗的成功提供替代预测指标。