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

NCT02729571 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-05-01

No results posted yet for this study

Summary

Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI or MTBVAC at equivalent dose (5x10E05 CFU/0.1mL) (n=9 in each group). Upon favourable safety review by the DSMB for all 18 adults up to day 28 after study vaccination, the second stage will commence in thirty-six (36) HIV unexposed, BCG naïve, newborn infants, randomized 1:3 to receive BCG Vaccine SSI or MTBVAC at one of three different dose levels ( (n=9 in each group).

Conditions

Interventions

BIOLOGICAL

MTBVAC

Live-attenuated tuberculosis vaccine

BIOLOGICAL

BCG

Commercially available live-attenuated tuberculosis vaccine

Sponsors & Collaborators

  • South African Tuberculosis Vaccine Initiative

    collaborator OTHER

  • TuBerculosis Vaccine Initiative

    collaborator OTHER

  • Triclinium Clinical Trial Project Management (Pty) Ltd.

    collaborator UNKNOWN

  • Universidad de Zaragoza

    collaborator OTHER

  • Biofabri, S.L

    lead INDUSTRY

Principal Investigators

  • Michele Tameris, MD · South African Tuberculosis Vaccine Initiative

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-09-30
Completion
2018-03-31

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 NCT02729571 on ClinicalTrials.gov