Double-blind, randomized, placebo-controlled Phase I Clinical Trial of the therapeutical antituberculous vaccine RUTI®

C. Vilaplana, E. Montané, S. Pinto, A. M. Barriocanal, G. Domenech, F. Torres, P. J. Cardona, Joan Costa

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82 Citations (Scopus)

Abstract

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 5 μg and going up to 200 μg, 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). © 2009 Elsevier Ltd. All rights reserved.
Original languageEnglish
Pages (from-to)1106-1116
JournalVaccine
Volume28
Issue number4
DOIs
Publication statusPublished - 22 Jan 2010

Keywords

  • Latent tuberculosis infection (LTBI)
  • Phase 1 Clinical Trial
  • RUTI ®

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