• The international consortium, MTBVAC AVANTE, officially launches its four-year program funded by Global Health EDCTP3.
• MTBVAC AVANTE offers crucial support to advance ongoing clinical trials in sub-Saharan Africa to evaluate the efficacy, safety, and immunogenicity of MTBVAC in adolescents, adults, and newborns.
• The initiative brings together 12 partners from Europe and Africa to accelerate clinical development and prepare the regulatory and policy framework for broad and equitable access to MTBVAC, should it be found safe and effective.

June 1, 2026. The path to develop urgently needed new vaccines against tuberculosis (TB), one of the leading infectious global health threats, has gained new international momentum. The MTBVAC AVANTE consortium has officially launched its activities following the signature of a €18.2 million award from Global Health EDCTP3, the European joint undertaking for clinical trials in developing countries.

Over the next four years, the 12-partner strong consortium will work to advance the clinical development of MTBVAC, the only TB vaccine candidate currently in clinical trials based on an attenuated form of Mycobacterium tuberculosis, the pathogen that causes TB disease in human. The programme will run through April 2030.

Under the name Advancing a Vaccine for Adolescent/Adult and Neonatal TB Epidemic (MTBVAC AVANTE), the project will support two major ongoing international clinical trials in high TB-burden regions across sub-Saharan Africa. The IMAGINE trial will evaluate MTBVAC’s ability to prevent pulmonary TB in adolescents and adults living in endemic areas, while the MTBVACN3 trial will assess whether the vaccine offers improved protection for newborns compared with the existing BCG vaccine, including infants born to mothers with HIV.

 The clinical trials aim to generate scientific evidence on the efficacy, safety, and immunogenicity of MTBVAC across different population groups. If MTBVAC is shown to be safe and efficacious, this evidence will support its regulatory approval and contribute to accelerating future TB prevention strategies in regions particularly affected by the disease.

The consortium partners will also work closely with local authorities, regional organisations, and communities to establish regulatory pathways and future vaccine introduction strategies, with the goal of accelerating access if the vaccine proves safe and effective.

The initiative is coordinated and led by Biofabri and brings together 12 internationally recognised organisations in clinical research, public health, vaccinology, TB, community engagement and advocacy.

“The signature of this agreement reinforces the international commitment to the development of innovative solutions against tuberculosis, one of the leading infectious threats to global health and a challenge that continues to have a profound health, social, and economic impact in many regions of the world,” said Esteban Rodríguez, CEO of Biofabri (Zendal Group). “We are honored to receive this new award from EDCTP3 Global Health to advance this promising programme.” 

Together, the consortium partners are committed to contributing to the development of new vaccination strategies to address one of the world’s greatest global public health challenges and to strengthen international preparedness against high-burden infectious diseases.

«MTBVAC AVANTE represents a powerful example of how international collaborations can develop urgently needed health technologies with equitable access firmly at the centre. Congratulations to all the partners for securing this opportunity to further advance the development of this promising TB vaccine candidate; and thank you to all the trial participants who make this work possible,» said Kundai Chinyenze, strategic partnerships and Africa regional director, IAVI. «We look forward to working together with all the partners in this exciting next step of MTBVAC’s development.»

ABOUT MTBVAC. MTBVAC is being developed for two purposes: as a more effective and potentially longer-lasting vaccine than BCG in newborns, and for the prevention of TB disease in adults and adolescents, for whom there is currently no effective vaccine.

Biofabri, a Spanish biopharmaceutical company, is working with two non-profit organizations, IAVI and TBVI, to advance the development of the vaccine candidate. MTBVAC was designed by the Spanish researcher Carlos Martin, from the University of Zaragoza, and Brigitte Gicquel, Ph.D., of Institut Pasteur, and was industrially developed and in-licensed by Biofabri (Zendal Group). The two ongoing clinical trials under MTBVAC AVANTE are the IAVI-sponsored Phase 2b IMAGINE clinical trial in adolescents and adults, conducted with 15 clinical research centre (CRC) partners in South Africa, Kenya, and Tanzania, and the Biofabri-sponsored Phase 3 MTBVACN3 clinical trial in newborns at six CRC partners in South Africa, Madagascar, and Senegal. In addition to Biofabri, partnerships with Bharat Biotech International Limited in India and Fundação Ataulpho de Paiva (FAP) in Brazil have been established to facilitate regional manufacturing capacities.

MTBVAC AVANTE

Project Full Title: Advancing a Vaccine for Adolescent/Adult and Neonatal TB Epidemic

Grant Agreement Number: 101249073

Project Duration: 48 months (4 years)

Total Project Budget: €74,817,319.70

Global Health EDCTP3 Contribution: €18,223,012.83 

«This project is part of the EDCTP3 Programme supported by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the GH EDCTP3 JU. Neither the European Union nor the granting authority can be held responsible for them.»

LIST OF PARTNERS

• BIOFABRI SLU (Spain)
• IAVI Stichting (Netherlands)
• TuBerculosis Vaccine Inititiatve (TBVI) (Netherlands)
• IAVI South Africa
• IAVI Africa (Kenya)
• Enhancing Care Foundation NPC (South Africa)
• Ifakara Health Institute (Tanzania)
• South African TB Vaccine Initiative (SATVI)
• Universidad de Zaragoza (Spain)
• University of Cape Town Lung Institute PTY LTD (South Africa)
• Wits Health Consortium PTY LTD (South Africa)
• Kenya Medical Research Institute

Biofabri. Biofabri is a biopharmaceutical company created in 2008 with the aim of researching, developing, and manufacturing vaccines for humans. Biofabri has extensivetechnical and scientific capacity in vaccines and immunotherapy. Biofabri belongs to the Zendal group, a Spanish biopharmaceutical business group made up of companies specializing in the development, manufacture and marketing of vaccines and other biotechnological products for human and animal health.

IAVI. IAVI is a global nonprofit biomedical research organization with locations in the U.S., Europe, Africa, and India that develops vaccines and antibodies for HIV, TB, emerging infectious diseases, and neglected diseases, with the goal of providing global access. It has contributed to efforts to evaluate most of the leading TB vaccine candidates now in clinical development and has a highly experienced TB vaccine clinical research team in South Africa.

TBVI is a non-profit foundation that facilitates the discovery and development of new, safe and effective TB vaccines that are accessible and affordable for all people. TBVI brings together partners from around the world by creating an enabling environment for TB vaccine research & innovation and product development, with the ultimate goal to relieve the burden of TB.