EV01: A phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium

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• 作者：Pierre-Alex ; re Bart ; Ruth Goodall ; Tristan Barber ; Alex ; re Harari ; Ana Guimaraes-Walker ; Mona Khonkarly ; Neil C. Sheppard ; Yol ; a Bangala ; Marie-Joelle Frachette ; Ralf Wagner ; Peter Liljeströ ; m ; Je
• 关键词：HIV preventative vaccine ; NYVAC-C ; Phase I
• 刊名：Vaccine
• 出版年：2008
• 期刊代码：89_0264410x
• 类别：imm
• 出版时间：13 June 2008
• 卷：26
• 期：25
• 页码：3153-3161
• 文件大小：758 K

摘要

NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag, pol, 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.