CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
MTBVAC live vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02013245
NCT02013245Phase 1Completed
CompareCT.gov

Phase I Double Blind, Randomized, Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC in Comparison With BCG in Elispot TB(ESAT-6, CFP10, PPD)- and HIV- Negative Volunteers

Biofabri, S.L·interventional·Posted Dec 17, 2013·Updated Mar 24, 2017

In Brief

A Phase 1 clinical trial evaluating MTBVAC live vaccine and Commercially available BCG live vaccine for Tuberculosis and Healthy. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation in inducing protection against tuberculosis (TB). Novel vaccines are essential to fight against the current world epidemics in tuberculosis and resistance to anti-TB drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, Healthy
CountriesSwitzerland
CollaboratorsUniversidad de Zaragoza, Centre Hospitalier Universitaire Vaudois, TuBerculosis Vaccine Initiative

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2013
Enrollment StartJan 1, 2013
Primary CompletionJun 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.5 years ago

Interventions

MTBVAC live vaccinebiological

Live-attenuated Mycobacterium tuberculosis vaccine

Commercially available BCG live vaccinebiological

Live-attenuated Mycobacterium bovis vaccine