Experimental Tuberculosis Unit, Germans Trias i Pujol Health Science Research Institute Foundation, Autonomous University of Barcelona, Crtra del Canyet s/n, Edifici Recerca, Catalonia, Spain.
Vaccine. 2010 Jan 22;28(4):1106-16. doi: 10.1016/j.vaccine.2009.09.134. Epub 2009 Oct 22.
A Phase I interventional Clinical Trial was performed with a potential tuberculosis vaccine, based on detoxified cellular fragments of M. tuberculosis, named RUTI. The objective was to evaluate the safety profile and T-cell immune responses over a 6-month period following subcutaneous inoculation. The double-blind, randomized and placebo-controlled trial was conducted in healthy volunteers, all recruited at one site. RUTI, at each of the four tested doses, starting from 5microg and going up to 200microg, and placebo were inoculated to groups of 4 and 2 volunteers respectively, consecutively. RUTI appeared to be well tolerated as judged by local and systemic clinical evaluation, though vaccine dose dependent local adverse reactions were recorded. T-cell responses of blood lymphocytes to PPD and a number of antigen subunits were elevated, when compared with controls subjects. These results support the feasibility of future evaluation, to be targeted at subjects with latent tuberculosis infection (LTBI).
一项基于结核分枝杆菌脱毒细胞碎片的潜在结核疫苗（RUTI）的 I 期干预临床试验已经进行。目的是评估皮下接种后 6 个月内的安全性概况和 T 细胞免疫应答。该双盲、随机、安慰剂对照试验在一个地点招募的健康志愿者中进行。RUTI 以 5μg 到 200μg 的 4 个测试剂量中的每一个，以及安慰剂分别接种给每组 4 名和 2 名志愿者。通过局部和全身临床评估判断，RUTI 耐受性良好，尽管记录了疫苗剂量依赖性的局部不良反应。与对照受试者相比，血液淋巴细胞对 PPD 和一些抗原亚单位的 T 细胞反应升高。这些结果支持针对潜伏性结核感染（LTBI）受试者进行进一步评估的可行性。
