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).
Subject(s)
Tuberculosis Vaccines/adverse effects , Tuberculosis Vaccines/immunology , Tuberculosis/therapy , Adolescent , Adult , Blood/immunology , Double-Blind Method , Drug-Related Side Effects and Adverse Reactions , Healthy Volunteers , Humans , Immunotherapy/adverse effects , Immunotherapy/methods , Injections, Subcutaneous , Male , Placebos/administration & dosage , T-Lymphocytes/immunology , Tuberculosis Vaccines/administration & dosage , Young AdultABSTRACT
Serotonin syndrome is a potentially life-threatening disorder of excessive serotoninergic activity often due to drug interactions. We report a case of serotonin syndrome induced by pharmacokinetic and pharmacodynamic interactions between three different selective serotonin-reuptake inhibitors (SSRI) and possibly ciprofloxacin. Extreme caution is necessary in patients treated with serotonin-reuptake inhibitors who need to be switched to another antidepressant or when they require the addition of concomitant drugs, especially serotoninergic drugs and isoenzimes of cytochrome P450 inhibitors.
Subject(s)
Ciprofloxacin/adverse effects , Selective Serotonin Reuptake Inhibitors/adverse effects , Serotonin Syndrome/chemically induced , Aged , Anti-Infective Agents/adverse effects , Anti-Infective Agents/pharmacology , Antidepressive Agents/adverse effects , Antidepressive Agents/pharmacology , Ciprofloxacin/pharmacology , Drug Interactions , Humans , Male , Selective Serotonin Reuptake Inhibitors/pharmacokineticsABSTRACT
A 50-year-old man with ankylosing spondylitis who developed neutropenia after treatment of etanercept, with two positive rechallenges, and after the first infliximab infusion, is described. Although leukopenia and neutropenia related to etanercept and infliximab have been described as rare adverse events from clinical trials data, their mechanism of action are unknown. This patient developed recurrent mild neutropenia after exposition of two different antitumor necrosis factors; therefore, it seems to be an adverse reaction related to the therapeutic group. Doctors should be aware of this potentially severe adverse effect in patients treated with antitumor necrosis factor.
