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

NCT02013245 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Biofabri, S.L
Phase	Phase 1
Status	COMPLETED
Enrolment	36
Start date	2013-01
Completion	2014-11

Conditions

• Tuberculosis
• Healthy

Interventions

• MTBVAC live vaccine
• Commercially available BCG live vaccine

Primary outcomes

• Number of Participants With Adverse Events up to 210 Days After Vaccination — 7 months follow up
  Safety and reactogenicity for all subjects as determined by: * Occurrence of solicited symptoms during the 7-day follow-up period following vaccination and occurrence of unsolicited symptoms during the 210-day follow-up period following vaccination. * Occurrence of grade 3 vaccine related local and general symptoms during the 210-day follow-up period following vaccination and occurrence of serious adverse events throughout the entire study period. * Haematological and biochemical safety test levels prior and after vaccination

Countries

Switzerland