Armijos Rodrigo X, Weigel M Margaret, Romero Luciano, Garcia Vinicio, Salazar Jorge
College of Health Sciences, Department of Biological Sciences, University of Texas at El Paso, El Paso, Texas, USA.
J Infect Dis. 2003 Jun 15;187(12):1959-61. doi: 10.1086/375399. Epub 2003 May 29.
During 12 months of follow-up in a randomized double-blind controlled field study, a killed whole-promastigote vaccine cocktail plus bacille Calmette-Guérin (BCG) adjuvant significantly reduced the incidence of cutaneous leishmaniasis (CL) in Ecuadorian children, compared with BCG alone. To determine how much longer protection might continue, the study was reblinded to permit 48 additional months of follow-up. During months 13-18, CL incidence remained lower in the vaccine group, compared with that in the control group (5.9% vs. 13.8%; chi2=8.8; P=.003), with vaccine efficacy calculated at 56.5% (95% confidence interval, 18.7%-76.7%); however, during months 24-60, no significant between-group differences were detected. Periodic administration of boosters may be necessary to maintain whole-parasite-vaccine protection against New World CL.
在一项随机双盲对照现场研究的12个月随访期间，与单独使用卡介苗相比，一种灭活全前鞭毛体疫苗鸡尾酒加卡介苗（BCG）佐剂显著降低了厄瓜多尔儿童皮肤利什曼病（CL）的发病率。为了确定保护作用可能持续多长时间，该研究重新设盲以允许进行额外48个月的随访。在第13至18个月期间，疫苗组的CL发病率仍低于对照组（5.9%对13.8%；χ2=8.8；P=0.003），计算出的疫苗效力为56.5%（95%置信区间，18.7%-76.7%）；然而，在第24至第60个月期间，未检测到组间显著差异。可能需要定期接种加强针以维持全寄生虫疫苗对新大陆CL的保护作用。
