About
About the project
Between 2026 and 2030, MTBVAC AVANTE is working to accelerate the clinical development and access planning of MTBVAC to demonstrate its use as a safe, effective, and accessible vaccine to prevent TB in newborns, adolescents, and adults.
Under the name Advancing a Vaccine for Adolescent/Adult and Neonatal TB Epidemic (MTBVAC-AVANTE), the 12-partner consortium is supporting the expansion and completion of two major ongoing clinical trials alongside important concurrent and post-trial activities to lay the ground for more rapid country introductions of MTBVAC, should it be found safe and effective.
International Consortium
12 leading organisations from Europe and Africa collaborating to advance TB vaccine development and access.
Clinical Development
Ongoing late-stage clinical trials evaluating MTBVAC in newborns, adolescents, and adults
Evidence Generation
Robust scientific and regulatory data to support future vaccine approval and access.
Our goal
MTBVAC-AVANTE will help accelerate TB vaccine development and access by:
Ensuring the phase 2b trial in adolescents and adults and phase 3 trial in infants of MTBVAC can be successfully completed in full.
Facilitating sample collection, storage, and analysis to generate evidence to support the broader TB vaccine development community.
Enabling extensive engagement with regulatory authorities, policymakers, and communities at the regional and local levels to anticipate potential barriers and help accelerate assessments by regulators and policymakers in high-burden countries.
Objectives
To evaluate the clinical efficacy of MTBVAC in adolescents and adults through ongoing late-stage clinical trials
To assess the safety and immunogenicity of MTBVAC in newborns, including infants born to mothers living with HIV and those born to mothers living without HIV
To generate scientific evidence supporting future regulatory submissions and policy decisions
To strengthen clinical research capacity in TB across Europe and Africa
To facilitate future access and implementation strategies for MTBVAC in high-burden countries
To consolidate international collaborative networks dedicated to TB vaccine research and development
Capacity strengthening
Capacity strengthening is one of the strategic pillars of MTBVAC AVANTE. The project contributes to the sustainable development of scientific and clinical research infrastructure in participating countries through:
- Training researchers and healthcare professionals
- Capacity building in Good Clinical Practice (GCP)
- Regulatory strengthening initiatives
- Improvement of laboratory and research infrastructure
- Training in data management, biostatistics and safety monitoring
- Community engagement and science communication initiatives
Impact
Through collaborative research and innovation, MTBVAC AVANTE aims to generate the evidence needed to advance TB vaccine development and access, contributing to improved health outcomes in high-burden regions and supporting progress toward global goals to end TB as a public health threat.
Expected outcomes
- Generation of 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.
How we work
MTBVAC AVANTE is designed to ensure efficient coordination, transparent decision-making, and rigorous scientific oversight across all partners, work packages, and clinical activities.
Governance
A robust governance framework underpins the project, providing clear oversight, accountability, and strategic direction. Through defined leadership structures, operational teams, and advisory bodies, the framework supports transparent decision-making, effective collaboration, and alignment across partners, activities, and clinical programmes.
| Governance body | Main responsibilities | Status / owner |
|---|---|---|
| Project Coordinator | Biofabri provides overall coordination, strategic alignment, reporting, and liaison with funding and regulatory stakeholders. Meet MTBVAC AVANTE’s partners on the Partners page. | Biofabri |
| Steering Committee (SC) | All the project partners are represented on the SC, which provides strategic decision-making, progress monitoring, risk review, and cross-partner coordination. | All Beneficiaries are represented in the SC |
| Scientific Project Leadership (SPL) | The SPL, led by IAVI South Africa, is responsible for MTBVAC AVANTE’s scientific guidance, clinical development input, and review of evidence generation activities. | IAVI South Africa |
| Product Development Team | The PDT ensures cross-Work Package coordination, progress monitoring, and strategic risk management of MTBVAC AVANTE work packages, while delivering technical recommendations to the Steering Committee. | WP Leads: Biofabri IAVI South Africa TBVI Stitching IAVI SATVI |
| Scientific Advisory Board (SAB) | The SAB provides independent scientific guidance and review of key project outputs. | We look forward to announcing the members soon! |
Work packages
MTBVAC AVANTE is organized into interconnected areas of work that together advance clinical research, evidence generation, capacity strengthening, and community and stakeholder engagement. Thanks to the diverse and complementary expertise of our partners, MTBVAC AVANTE is well placed to ensure coordinated delivery across the full programme.
| WP | Area | Scope | Lead |
|---|---|---|---|
| WP1 | Project Management and Coordination | Manage project coordination, governance, reporting, risk management, consortium alignment, and communication with Global Health EDCTP3. | Biofabri |
| WP2 | Scientific project leadership | Provide overall scientific leadership, oversight, and coherence across WPs to ensure project and programmatic coherence. | IAVI South Africa |
| WP3 | MTBVAC Infants Clinical Development | Generate evidence of MTBVAC’s improved efficacy compared to BCG in preventing TB disease in infants in TB-endemic regions of sub-Saharan Africa. | TBVI |
| WP4 | MTBVAC Adolescents and Adults Clinical Development | Generate evidence to determine the protective efficacy of MTBVAC against pulmonary TB disease in adolescents and adults. | IAVI South Africa |
| WP5 | Regulatory engagement and policy translation for access | Ensure the timely translation of findings into public health practice and policy, including engagement with regulatory authorities and policy makers. | Stichting IAVI |
| WP6 | Communication & Dissemination | Ensure project visibility, stakeholder engagement, publication planning, and the development of digital content and the project website. | Biofabri |
| WP7 | Capacity building | Provide training and facilitate infrastructure reinforcement and sustainable research capacity development. | SATVI |