- The international trial, conducted in South Africa, Senegal and Madagascar, will assess whether MTBVAC can provide improved protection against tuberculosis compared with BCG, the century-old vaccine currently used to protect infants.
- MTBVAC is the only live-attenuated TB vaccine candidate derived from M. tuberculosis currently undergoing clinical development across all age groups.
- The milestone follows the recent completion of enrolment of 5,500 adolescents and adults in the IMAGINE trial, strengthening the broader clinical development programme of MTBVAC.
O Porriño, Spain, XX September 2026. Biofabri, part of the Zendal Group, has announced the completion of the vaccination stage of the Phase 3 clinical trial evaluating the tuberculosis (TB) vaccine candidate MTBVAC in newborns (MTBVACN3, NCT04975178), with 7,120 participants enrolled and vaccinated across South Africa, Senegal and Madagascar.
The trial reached its target of 7,120 enrolled and vaccinated newborns on August 31, 2026, marking the completion of the vaccination stage. The trial remains ongoing, with participants continuing into the follow-up period required to assess the safety and efficacy of MTBVAC.
The study is designed to determine whether MTBVAC can safely prevent tuberculosis disease in newborns and provide improved protection compared with BCG, the only currently approved tuberculosis vaccine.
Completion of the vaccination stage represents a major milestone in the clinical development of MTBVAC and moves the study into its next critical phase: determining whether the vaccine can provide improved protection against tuberculosis.
Tuberculosis remains one of the world’s leading causes of death from an infectious disease. In 2024, an estimated 1.23 million people died from TB worldwide. Although BCG provides important protection against severe forms of tuberculosis in young children, the need for more effective vaccines remains a global public health priority.
A pivotal Phase 3 study
The first participant in the MTBVAC neonatal Phase 3 trial was enrolled in October 2022.
The study is sponsored by Biofabri with support from the TuBerculosis Vaccine Initiative (TBVI), the European & Developing Countries Clinical Trials Partnership (EDCTP), and the European Commission and the European Health and Digital Executive Agency (HaDEA).
Progression to Phase 3 was supported by results from a previous Phase 2a dose-defining study conducted in South African newborns. At the selected doses, MTBVAC showed a safety profile comparable to BCG and induced immune responses similar to or stronger than those observed with BCG.
The Phase 3 trial involves an international network of research institutions and clinical centres, including the South African Tuberculosis Vaccine Initiative (SATVI), Enhancing Care Foundation, Stellenbosch University FAMCRU, Wits VIDA Research Unit, Institute Pasteur de Madagascar, Centre de Recherche Biomédicale Espoir Pour La Santé, Senegal[IM1] , Espoir Pour La Santé and the University of Zaragoza.
Advancing MTBVAC across age groups
The milestone follows the recent completion of enrolment in the IAVI-sponsored IMAGINE Phase 2b trial, which recruited 5,500 adolescents and adults across 16 clinical sites in South Africa, Kenya and Tanzania.
Together, these two major efficacy trials include 12,620 newborns, adolescents and adults, reinforcing the scale and breadth of the MTBVAC clinical development programme.
Additional Phase 1 and Phase 2 studies are also being conducted in India in collaboration with Bharat Biotech International Limited (BBIL).
MTBVAC is being developed with the objective of assessing its potential to protect people against tuberculosis across different stages of life.
“This milestone reflects the extraordinary level of collaboration required to conduct a clinical trial of this scale across several countries,” said Esteban Rodriguez, CEO and President of Biofabri.
“We are deeply grateful to the participants and their families, investigators, funders and partners working alongside Biofabri to advance MTBVAC. Developing an effective and accessible vaccine against one of the world’s deadliest infectious diseases would represent a major achievement for global public health.”
Rolando Pajón, Ph.D., Chief Medical and Scientific Officer of Biofabri, added:
“Completing vaccination of 7,120 newborns in this Phase 3 trial, alongside the enrolment of 5,500 adolescents and adults in the IMAGINE trial and the additional clinical studies underway in India with Bharat Biotech, represents one of the most significant milestones in the development of MTBVAC.
“It brings us closer to understanding the vaccine’s potential to protect populations affected by tuberculosis and reflects the exceptional commitment of the participants, investigators and partners who have made this programme possible.”
Completion of vaccination in the neonatal Phase 3 trial represents another important step toward determining whether MTBVAC could provide improved protection against tuberculosis in newborns.
About MTBVAC
MTBVAC is a single-dose vaccine delivered via intradermal administration. It does not require an adjuvant and is well suited for use in difficult-to-reach locations.
MTBVAC is being developed by Biofabri (Zendal Group). It is the only live-attenuated TB vaccine candidate derived from M. tuberculosis currently in clinical trials across all age groups.
This represents a notable difference from BCG, the only approved TB vaccine, which is derived from Mycobacterium bovis, the bovine form of tuberculosis, and is only used in neonates.
About Biofabri
Biofabri is a clinical-stage biopharmaceutical company founded in 2008 to research, and develop vaccines for human use. With strong scientific and technical expertise in vaccines and immunotherapies, the company is responsible for the clinical and industrial development of the tuberculosis vaccine candidate MTBVAC, and a BCG-based Bladder Cancer Immunotherapy, both currently in advanced stages of clinical development.
Biofabri is part of Zendal, a biopharmaceutical group comprising companies specialized in human and animal health
About TBVI
The TuBerculosis Vaccine Initiative (TBVI) is a non-profit foundation that facilitates the discovery and development of new, safe and effective tuberculosis vaccines that are accessible and affordable for all people.
TBVI brings together partners from around the world, creating an enabling environment for TB vaccine research, innovation and product development, with the ultimate goal of reducing the global burden of tuberculosis.
About IAVI
IAVI is a global non-profit biomedical research organisation dedicated to addressing unmet health challenges, including HIV, tuberculosis and a range of emerging infectious diseases.
Its mission is to translate scientific discoveries into affordable and globally accessible public health tools.
About Bharat Biotech
Bharat Biotech International Limited (BBIL) is a biotechnology company with extensive R&D and manufacturing capabilities in vaccines and biotherapeutics.
Its mission is to develop affordable, safe and high-quality vaccines and biotherapeutics, with a particular focus on addressing infectious diseases and health needs in emerging markets.
About Unizar
The University of Zaragoza, Spain is the main center for technological innovation in the Ebro Valley. It participates in different exchange programs, collaborating with universities and research centers in Europe, Latin America, and the United States. Microbiologists from the university associated with Centro de Investigación Biomédica en Red Enfermadades Respiratorias (CIBERES) led the research and subsequent discovery of the experimental vaccine MTBVAC. Within the TuBerculosis Vaccine Initiative (TBVI) consortium, the MTBVAC discovery phase has included rigorous clinical characterization by independent laboratories and research groups.
Biofabri Media contact
Email: b.diaz@zendal.com |
Phone: +34 986330400