Bart Pierre-Alexandre, Goodall Ruth, Barber Tristan, Harari Alexandre, Guimaraes-Walker Ana, Khonkarly Mona, Sheppard Neil C, Bangala Yolanda, Frachette Marie-Joelle, Wagner Ralf, Liljeström Peter, Kraehenbuhl Jean-Pierre, Girard Marc, Goudsmit Jaap, Esteban Mariano, Heeney Jonathan, Sattentau Quentin, McCormack Sheena, Babiker Abdel, Pantaleo Giuseppe, Weber Jonathan
Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Vaccine. 2008 Jun 13;26(25):3153-61. doi: 10.1016/j.vaccine.2008.03.083. Epub 2008 May 27.
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.
NYVAC-C（vP2010）是一种表达HIV-1 C亚型gag、pol、env和nef抗原的重组载体，在伦敦和洛桑针对健康的HIV阴性志愿者进行了I期研究。24名参与者在第0周和第4周被随机分配接受NYVAC-C（20名）或匹配的安慰剂（4名），并在48周内评估安全性和免疫原性。未发生严重不良事件，也没有导致NYVAC-C/安慰剂停药、中断或减量的临床或实验室异常或其他事件。在严格标准下，10名接受评估的参与者中有一半在ELISpot试验中产生反应，这为DNA-NYVAC-C与单独NYVAC-C比较的样本量提供了依据。
