Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates

PHASE2CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

February 12, 2019

Primary Completion Date

May 17, 2022

Study Completion Date

May 17, 2022

Conditions
Tuberculosis
Interventions
BIOLOGICAL

MTBVAC

Live-attenuated Mycobacterium tuberculosis based on the deletion of phoP and fadD26 virulence genes

BIOLOGICAL

BCG

Live-attenuated Mycobacterium bovis obtained by subculture passaging in ox-bile and glycerated potatoes between 1908-1921 by Albert Calmette and Camille Guerin. BCG is the only licensed vaccine today against tuberculosis (TB) mainly used in TB-endemic countries.

Trial Locations (1)

6850

SATVI: Worcester, Worcester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

South African Tuberculosis Vaccine Initiative

OTHER

collaborator

Universidad de Zaragoza

OTHER

collaborator

TuBerculosis Vaccine Initiative

OTHER

lead

Biofabri, S.L

INDUSTRY