Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

September 30, 2016

Study Completion Date

March 31, 2018

Conditions
Tuberculosis
Interventions
BIOLOGICAL

MTBVAC

Live-attenuated tuberculosis vaccine

BIOLOGICAL

BCG

Commercially available live-attenuated tuberculosis vaccine

Trial Locations (1)

6850

South African Tuberculosis Vaccine Initiative, Brewelskloof Hospital, Worcester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

South African Tuberculosis Vaccine Initiative

OTHER

collaborator

TuBerculosis Vaccine Initiative

OTHER

collaborator

Triclinium Clinical Trial Project Management (Pty) Ltd.

UNKNOWN

collaborator

Universidad de Zaragoza

OTHER

lead

Biofabri, S.L

INDUSTRY

NCT02729571 - Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults | Biotech Hunter | Biotech Hunter