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

• Published in: Vaccine Vol. 28; no. 4; pp. 1106 - 1116
• Main Authors: Vilaplana, C, Montané, E, Pinto, S, Barriocanal, A.M, Domenech, G, Torres, F, Cardona, P.J, Costa, Joan
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 22.01.2010; Elsevier; Elsevier Limited
• Subjects: Adolescent; Adult; Allergy and Immunology; Applied microbiology; Biological and medical sciences; Blood; Blood - immunology; Blood pressure; Body mass index; Clinical trials; Consent; Disease; Double-Blind Method; Drug dosages; Drug-Related Side Effects and Adverse Reactions; Fundamental and applied biological sciences. Psychology; Good Manufacturing Practice; Healthy Volunteers; Humans; Immune response; Immunization; Immunotherapy - adverse effects; Immunotherapy - methods; Infection; Injections, Subcutaneous; Inoculation; Latent tuberculosis infection (LTBI); Lymphocytes; Lymphocytes T; Male; Microbiology; Mycobacterium; Phase 1 Clinical Trial; Placebos - administration & dosage; RUTI; Side effects; Substance abuse treatment; T-Lymphocytes - immunology; Tuberculosis; Tuberculosis - therapy; Tuberculosis Vaccines - administration & dosage; Tuberculosis Vaccines - adverse effects; Tuberculosis Vaccines - immunology; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Young Adult; Spain; Latent tuberculosis infection (LTBI); RUTI; Phase 1 Clinical Trial; Phase I trial; Latent tuberculosis; Clinical trial; Vaccine
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2009.09.134

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).