EV02:: A Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone
EV02:: A Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone
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DOI：
10.1016/j.vaccine.2008.02.072
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发表时间：
2008-06-13
期刊：
影响因子：
5.5
通讯作者：
Weber, Jonathan
中科院分区：
文献类型：
--
作者：
McCormack, Sheena;Stohr, Wolfgang;Weber, Jonathan
这项随机对照试验的目的是观察在第0周和第4周通过肌内途径给药的4 mg/ml DNA-C预充与第20周和第24周的NYVAC-C相比，是否增加了第26周和/或第28周通过干扰素（IFN）-γ ELISpot测定测量的HIV特异性T细胞应答的参与者比例。尽管2名个体在第一次DNA-C后由于不良事件（1例血管迷走神经性; 1例丙氨酸转氨酶一过性无症状升高）而停药，但疫苗耐受性良好。其他3例患者未能完成治疗方案（11例改变主意; 2例失访）。在完成方案的35名患者中，DNA-C组90%（18/20）的ELISpot应答，而单独接受NYVAC-C的患者为33%（5/15）（p =0.001）。大多数人的反应是信封（21/23）。在对包膜和其他肽有反应的9个个体中，8个在DNA-C组中。这些有希望的结果表明DNA-C是一种有效的引发剂，值得进一步研究。(C)2008 Elsevier Ltd.保留AR权利。
The aim of this randomised controlled trial was to see if the addition of 4mg/ml DNA-C priming given by the intramuscular route at weeks 0 and 4 to NYVAC-C at weeks 20 and 24, safety increased the proportion of participants with HIV-specific T-cell responses measured by the interferon (IFN)-gamma ELISpot assay at weeks 26 and/or 28 compared to NYVAC-C alone. Although 2 individuals discontinued after the first DNA-C due to adverse events (1 vaso-vagal; 1 transient, asymptomatic elevation in alanine transaminase), the vaccines were well tolerated. Three others failed to complete the regimen (11 changed her mind; 2 lost to follow-up). Of the 35 that completed the regimen 90% (18/20) in the DNA-C group had ELISpot responses compared to 33% (5/15) that received NYVAC-C alone (p =0.001). Responses were to envelope in the majority (21/23). Of the 9 individuals with responses to envelope and other peptides, 8 were in the DNA-C group. These promising results suggest that DNA-C was an effective priming agent, that merits further investigation. (C) 2008 Elsevier Ltd. AR rights reserved.