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

@article{Vilaplana2010DoubleblindRP,
  title={Double-blind, randomized, placebo-controlled Phase I Clinical Trial of the therapeutical antituberculous vaccine RUTI.},
  author={Cristina Vilaplana and Eva Montan{\'e} and Sara De Pinto and Ana Mar{\'i}a Barriocanal and Gema Dom{\'e}nech and Ferran Torres and Pere Joan Cardona and J de S Costa},
  journal={Vaccine},
  year={2010},
  volume={28 4},
  pages={1106-16}
}
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… CONTINUE READING

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