At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-Blind, Randomized, Placebo-Controlled Phase I Study, to Study the Tolerability and Immunogenicity of 4 RUTI Antituberculous Vaccine Different Doses (5, 25, 100 y 200µg of FCMtb) in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating RUTI and placebo of the vaccine RUTI for Latent Tuberculosis Infection and Tuberculosis. Completed, enrolled 24 participants across 3 sites.
Detailed Summary
The aim of this study is to evaluate the safety of a new vaccine against Tuberculosis (RUTI) when administered to healthy adult volunteers, compared to placebo; and determine its safe dosage range. An initial evaluation of immune responses to the vaccine compared to placebo will also be undertaken. In the present Phase I clinical trial, four increasing doses of RUTI will be tested, the groups composed by 6 volunteers each. (Total of 24 volunteers). The escalation to a new dose to test will be done after the safety of the previous dose has been ensured. For each dose of FCMtb to test, each volunteer will be inoculated twice (at day 0 and day 28) with RUTI (4 volunteers) or placebo (2 volunteers) and will be followed-up up to 25 weeks from the first inoculation. The global length of the study will be approximately 15 months.
Study Details
Timeline
Interventions
dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28
placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28