Double-blind, randomized, placebo-controlled Phase I Clinical Trial of the therapeutical antituberculous vaccine RUTI®
2009; Elsevier BV; Volume: 28; Issue: 4 Linguagem: Inglês
10.1016/j.vaccine.2009.09.134
ISSN1873-2518
AutoresCristina Vilaplana, Eva Montané, Sergio Pinto, Ana María Barriocanal, Gema Doménech, Ferràn Torres, Pere‐Joan Cardona, Joan Costa‐Font,
Tópico(s)Mycobacterium research and diagnosis
ResumoA 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).
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