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

NCT03536117 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2025-04-27

No results posted yet for this study

Summary

A Phase 2a dose-defining study of MTBVAC to evaluate the safety, reactogenicity, immunogenicity, and potential for IGRA conversion and reversion, of MTBVAC in South African newborns. Ninety-nine HIV unexposed, BCG naïve newborns will be randomized to receive either BCG 2.5 x 105 CFU (n=24) or MTBVAC at one of three dose levels (n=75). Allocation will be double blind. Enrolment will be sequential into 3 cohorts of increasing MTBVAC dose (Cohort 1: n=25 MTBVAC 2.5 x 10E+04 and n=8 BCG; Cohort 2: n=25 MTBVAC 2.5 x 10E+05 and n=8 BCG; Cohort 3: n=25 MTBVAC 2.5 x 10E+06 and n=8 BCG). Dose escalation will be staggered to allow gradual evaluation of safety; final selection of the dose for Cohort 3 will be based on all available safety and immunogenicity data.

Conditions

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.

Sponsors & Collaborators

  • South African Tuberculosis Vaccine Initiative

    collaborator OTHER

  • Universidad de Zaragoza

    collaborator OTHER

  • TuBerculosis Vaccine Initiative

    collaborator OTHER

  • Biofabri, S.L

    lead INDUSTRY

Principal Investigators

  • Michele Tameris, MD · Study Principal Investigator South African Tuberculosis Vaccine Initiative

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Max Age
96 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2022-05-17
Completion
2022-05-17

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs
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 NCT03536117 on ClinicalTrials.gov