McCormack Sheena, Stöhr Wolfgang, Barber Tristan, Bart Pierre-Alexandre, Harari Alexandre, Moog Christiane, Ciuffreda Donatella, Cellerai Cristina, Cowen Miranda, Gamboni Romilda, Burnet Séverine, Legg Ken, Brodnicki Elizabeth, Wolf Hans, Wagner Ralf, Heeney Jonathan, Frachette Marie-Joëlle, Tartaglia Jim, Babiker Abdel, Pantaleo Giuseppe, Weber Jonathan
MRC Clinical Trials Unit, 222 Euston Road, London NW1 2DA, UK.
Vaccine. 2008 Jun 13;26(25):3162-74. doi: 10.1016/j.vaccine.2008.02.072. Epub 2008 May 6.
The aim of this randomised controlled trial was to see if the addition of 4 mg/ml DNA-C priming given by the intramuscular route at weeks 0 and 4 to NYVAC-C at weeks 20 and 24, safely 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 (1 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.
这项随机对照试验的目的是，观察在第20周和第24周给予NYVAC-C疫苗的基础上，于第0周和第4周通过肌肉注射途径添加4mg/ml的DNA-C进行启动免疫，与单独使用NYVAC-C相比，能否在第26周和/或第28周时安全地提高通过干扰素（IFN）-γ ELISpot检测法测得的HIV特异性T细胞反应参与者的比例。尽管有2名个体在首次注射DNA-C后因不良事件退出试验（1例血管迷走性晕厥；1例丙氨酸转氨酶短暂无症状升高），但疫苗耐受性良好。另有3人未完成方案（1人改变主意；2人失访）。在完成方案的35人中，DNA-C组有90%（18/20）的人有ELISpot反应，而单独接受NYVAC-C的人中有33%（5/15）有反应（p=0.001）。大多数反应针对包膜蛋白（21/23）。在对包膜蛋白和其他肽有反应的9个人中，有8人在DNA-C组。这些有前景的结果表明，DNA-C是一种有效的启动免疫剂，值得进一步研究。
