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Evaluating the Safety and Immunogenicity of MTBVAC

NCT05947890 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-03-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa

Conditions

Interventions

BIOLOGICAL

MTBVAC

The MTBVAC vaccine is a freeze-dried lyophilized pellet containing live attenuated strain MTBVAC01 derived from Mycobacterium tuberculosis (M.tb). Excipients include sucrose and sodium glutamate.

BIOLOGICAL

BCG

The active substance in BCG vaccine is a freeze-dried powder containing live attenuated Mycobacterium bovis BCG, Danish strain 1331 and sodium glutamate as a stabilizer. The powder is white and crystalline and may be difficult to see due to the small amount contained in each vial.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Biofabri, S.L

    collaborator INDUSTRY

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • HIV Vaccine Trials Network

    lead NETWORK

Principal Investigators

  • Mark Hatherill · South African Tuberculosis Vaccine Initiative

  • Limakatso Lebina · Africa Health Research Institute (AHRI)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-30
Primary Completion
2027-04-05
Completion
2027-04-05

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 NCT05947890 on ClinicalTrials.gov