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Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.

NCT02013245 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-03-24

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

MTBVAC live vaccine

Live-attenuated Mycobacterium tuberculosis vaccine

BIOLOGICAL

Commercially available BCG live vaccine

Live-attenuated Mycobacterium bovis vaccine

Sponsors & Collaborators

  • Universidad de Zaragoza

    collaborator OTHER

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • TuBerculosis Vaccine Initiative

    collaborator OTHER

  • Biofabri, S.L

    lead INDUSTRY

Principal Investigators

  • François Spertini, MD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-06-30
Completion
2014-11-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02013245 on ClinicalTrials.gov