TY - JOUR
T1 - Double-blind, randomized, placebo-controlled Phase I Clinical Trial of the therapeutical antituberculous vaccine RUTI®
AU - Vilaplana, C.
AU - Montané, E.
AU - Pinto, S.
AU - Barriocanal, A. M.
AU - Domenech, G.
AU - Torres, F.
AU - Cardona, P. J.
AU - Costa, Joan
PY - 2010/1/22
Y1 - 2010/1/22
N2 - 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.
AB - 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.
KW - Latent tuberculosis infection (LTBI)
KW - Phase 1 Clinical Trial
KW - RUTI ®
U2 - 10.1016/j.vaccine.2009.09.134
DO - 10.1016/j.vaccine.2009.09.134
M3 - Article
SN - 0264-410X
VL - 28
SP - 1106
EP - 1116
JO - Vaccine
JF - Vaccine
IS - 4
ER -