EV01:: A phase I trial in healthy HIV negative volunteers to evaluate a clade CHIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium
EV01:: A phase I trial in healthy HIV negative volunteers to evaluate a clade CHIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium
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DOI：
10.1016/j.vaccine.2008.03.083
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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：
Bart, Pierre-Alexandre;Goodall, Ruth;Weber, Jonathan
NYVAC-C （vP2010）是一种表达HIV亚型C gag、pot、env和nef抗原的重组载体，在伦敦和洛桑的健康HIV阴性志愿者中进行了一期研究。24名参与者在第0周和第4周随机接受NYVAC-C（20人）或匹配的安慰剂（4人），并在48周内评估安全性和免疫原性。没有严重的不良事件，没有临床或实验室异常或其他事件导致NYVAC-C/安慰剂的停药、中断或剂量减少。在严格的标准下，10个被评估的患者中有一半在ELISpot检测中有反应，这告知了DNA-NYVAC-C与单独NYVAC-C比较的样本量。(C) 2008 Elsevier Ltd版权所有。
NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag, pot, env and nef antigens, was tested in a phase I study in healthy, HIV negative volunteers in London and Lausanne. Twenty-four participants were randomised to receive NYVAC-C (20) or matching placebo (4) at weeks 0 and 4, and assessed for safety and immunogenicity over 48 weeks. There were no serious adverse events, and no clinical or laboratory abnormalities or other events that led to withdrawal, interruption or dose reduction of the NYVAC-C/placebo. Half of the 10 assessed responded in the ELISpot assay under stringent criteria, which informed the sample size for a DNA-NYVAC-C comparison to NYVAC-C alone. (C) 2008 Elsevier Ltd. All rights reserved.