Together against tuberculosis
Advancing a next-generation vaccine for global health
MTBVAC AVANTE is an international research initiative bringing together leading institutions from Europe and Africa to accelerate the development of a new tuberculosis vaccine and contribute to the global effort to end TB.
About the Project
MTBVAC is the first live attenuated TB vaccine derived from a human strain of Mycobacterium tuberculosis to reach advanced clinical development.
Starting in June 2026, the 12-partner MTBVAC AVANTE consortium is working to advance clinical development of MTBVAC and ensure the necessary clinical and regulatory evidence is well placed to support licensure and future global implementation, should MTBVAC be found safe and effective. MTBVAC AVANTE is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP3).
Tuberculosis remains world’s deadliest infectious disease affecting poorer countries disproportionately.
First live TB vaccine from a human strain in advanced clinical trials.
A 12-partner consortium is generating the evidence for future licensure.
10.7M
PEOPLE AFFECTED
by tuberculosis every year (WHO, 2024)
1.23M
TB-RELATED DEATHS
recorded annually worldwide
12
INTERNATIONAL PARTNERS
collaborating across Europe and Africa
€74.8M
TOTAL PROJECT BUDGET
funded in part by EDCTP3
Objectives
MTBVAC AVANTE will help accelerate TB vaccine development and access by pursuing the following objectives:
1
Clinical efficacy in adolescents and adults
Evaluating the clinical efficacy of MTBVAC in adolescents and adults through advanced-stage clinical studies.
2
Safety and immunogenicity in newborns
Assessing the safety and immunogenicity of MTBVAC in newborns, including infants born to mothers living with HIV.
3
Regulatory and policy evidence
Generating scientific evidence to support future regulatory submissions and policy decisions.
4
Future access and implementation
Facilitating access and implementation strategies for MTBVAC in high-burden countries.
Project Structure
MTBVAC AVANTE is organised around three strategic pillars that together advance clinical research, evidence generation and capacity strengthening.
A robust governance framework, spanning a Steering Committee, Scientific Leadership Committee and Clinical Operations Group, ensures transparent decision-making across all 12 partners.
International Consortium
12 leading organisations from Europe and Africa collaborating to advance tuberculosis vaccine research.
Clinical Development
Advanced clinical studies evaluating MTBVAC in newborns, adolescents, and adults.
Evidence Generation
Robust scientific and regulatory data to support future vaccine approval and access.
Clinical Development
MTBVAC AVANTE is supporting two major ongoing clinical trials that are designed to generate robust evidence on the safety, immunogenicity and efficacy of MTBVAC across key target populations.
MTBVACN3 — Phase 3
Evaluating MTBVAC vs BCG in newborns across Madagascar, Senegal and South Africa.
IMAGINE — Phase 2b
Evaluating MTBVAC in adolescents and adults across South Africa, Kenya and Tanzania.
Evidence & Regulation
Generating scientific and regulatory evidence to support future licensure.
Access & Introduction
Laying the ground for rapid country introduction, should MTBVAC prove safe and effective.
Expected Impact
Robust clinical efficacy, safety and immunogenicity data for the MTBVAC vaccine candidate.
Scientific evidence to support future regulatory submissions.
Progress towards access and implementation strategies for MTBVAC.
Enhanced scientific and clinical research capacity in participating countries.
Our Partners
12 leading organisations from Europe and Africa are collaborating to advance the development of MTBVAC, a next-generation tuberculosis vaccine.
Funding
MTBVAC AVANTE is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP3), a European Union initiative dedicated to accelerating the development of medical interventions against infectious diseases that disproportionately affect low- and middle-income countries.
Project scope
Clinical, regulatory, scientific and capacity-strengthening activities.
Funding body
European & Developing Countries Clinical Trials Partnership (EDCTP3)
Funding Information
- Total project budget: €74,817,319.70
- EDCTP3 contribution: €18,223,012.83
This funding supports clinical, regulatory, scientific and capacity-strengthening activities throughout the four-year duration of the project.
