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 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).
journal_name
Vaccinejournal_title
Vaccineauthors
Vilaplana C,Montané E,Pinto S,Barriocanal AM,Domenech G,Torres F,Cardona PJ,Costa Jdoi
10.1016/j.vaccine.2009.09.134subject
Has Abstractpub_date
2010-01-22 00:00:00pages
1106-16issue
4eissn
0264-410Xissn
1873-2518pii
S0264-410X(09)01494-7journal_volume
28pub_type
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