- Tuberculosis (TB) remains the world’s deadliest infectious disease, with more than 1.2 million deaths in 2023.
- MTBVAC is a new live attenuated tuberculosis vaccine being developed with a dual purpose: to provide more effective and potentially longer-lasting protection than BCG in newborns, and to prevent tuberculosis disease in adults and adolescents, a group for which there is currently no effective vaccine.
- The clinical trial called IMAGINE evaluates the safety and efficacy of MTBVAC in preventing tuberculosis in adolescents and adults with latent TB infection and will be conducted in South Africa, Kenya and Tanzania.
PORRIÑO, SPAIN and NEW YORK, USA—February 26, 2025—The Spanish biopharmaceutical company Biofabri, a subsidiary of the Zendal Group, and IAVI, a global non-profit organization dedicated to scientific research, announced today the administration of the first doses of the MTBVAC vaccine in the IMAGINE clinical trial (MTBVAC Investigation to Accelerate Global Immunization Against a Neglected Epidemic). The first trial participants were vaccinated on February 19, 2025, at Be Part Research, Paarl, South Africa.
IMAGINE, sponsored by IAVI and financially supported by Open Philanthropy, the Gates Foundation, and the German Federal Ministry of Education and Research through the KfW Development Bank, is a large-scale study that will evaluate the safety and efficacy of MTBVAC, a vaccine candidate against tuberculosis.
The IMAGINE trial aims to evaluate the safety and efficacy of MTBVAC for preventing active pulmonary tuberculosis in adolescents and adults. This Phase 2b trial plans to enroll 4,300 participants with latent TB infection at 15 sites in South Africa, Kenya, and Tanzania. Participants will be monitored for two to three years to assess the efficacy of the MTBVAC vaccine candidate, which is administered as a single dose via intradermal injection.
“We are thrilled to see the launch of the IMAGINE trial,” said Mark Feinberg, president and CEO of IAVI. “An innovative and effective vaccine against tuberculosis, the world’s deadliest infectious disease, would have a significant impact on global public health. This trial marks a key milestone in global efforts to reduce the devastating impact of tuberculosis. We are deeply grateful for the support of our funders and partners, and, most importantly, the volunteers who will participate in the IMAGINE trial.”
Tuberculosis caused 1,250,000 deaths in 2023 and is recognized worldwide as the deadliest infectious disease. The only approved vaccine against tuberculosis, the Bacillus Calmette-Guérin (BCG) vaccine, was introduced more than 100 years ago. The BCG vaccine provides partial protection to children but does not prevent tuberculosis in adolescents or adults. An effective tuberculosis vaccine for children, adolescents, and adults would save millions of lives that would otherwise be lost to tuberculosis over time.
A crucial new vaccine against tuberculosis
MTBVAC was designed by Spanish researcher Carlos Martín, from the University of Zaragoza, and Brigitte Gicquel, Ph.D., from the Pasteur Institute, and industrially developed and licensed by Biofabri of the Zendal group.
It is the only live attenuated tuberculosis vaccine derived from Mycobacterium tuberculosis currently in clinical trials. This is a notable difference from BCG, which is derived from Mycobacterium bovis, the bovine form of tuberculosis.
MTBVAC has been evaluated in two Phase 2 clinical trials in adults and newborns, and has been shown to have comparable or favorable immunogenicity and safety profiles at different doses compared to BCG. Biofabri is also conducting a Phase 3 clinical trial of the MTBVAC vaccine in newborns in South Africa, Madagascar, and Senegal. Additionally, since January 2024, Biofabri and the HIV Vaccine Trials Network have been conducting a Phase 2a clinical trial to evaluate the safety and immunogenicity of MTBVAC in people with and without HIV.
“The IMAGINE trial is an important new effort to develop a vaccine capable of combating the world’s deadliest disease,” said Lewis Schrager, Director of Tuberculosis Vaccine Development at IAVI. “Because MTBVAC is a one-dose vaccine, it has the potential to prevent millions of cases of tuberculosis if it proves effective, especially in hard-to-reach communities around the world.”
Future global supply
If MTBVAC proves effective, Biofabri, IAVI and their partners will work together to ensure a sufficient and affordable supply of MTBVAC by guaranteeing its availability in low- and middle-income countries.
“Biofabri, together with its partners in Asia and South America, will guarantee the global supply of the vaccine. As soon as MTBVAC proves to be safe and effective, Biofabri, along with our partners, has a strategy in place to ensure that the vaccine is manufactured and supplied in sufficient quantities to newborns, adolescents, and adults, and is accessible and affordable in low- and middle-income countries,” stated Esteban Rodríguez, CEO of Biofabri.
“An effective vaccine against tuberculosis is urgently needed. Historically the leading cause of death worldwide, tuberculosis causes 11 million new cases of the disease each year. In addition to the millions of resulting deaths, tuberculosis is also associated with a significant reduction in gross domestic product in low- and middle-income countries, as young and economically active people are often the most affected. Even after effective treatment, patients often suffer lung damage and scarring, making tuberculosis the most common and significant cause of lung disability in many endemic countries. On the other hand, drug-resistant tuberculosis is an emerging threat to TB control, as it is difficult and more expensive to treat. Therefore, I am delighted to be part of the MTBVAC trial, which has the potential to transform the lives and economies of millions of people and dozens of countries,” said Dr. Keertan Dheda, Professor of Respiratory Medicine, Director of the Centre for Pulmonary Infection and Immunity, and Head of the Division of Pulmonology in the Department of Medicine at the University of Cape Town, and principal investigator of the IMAGINE trial.”
International support for a scientific breakthrough
“The IMAGINE trial is an exciting step forward in tuberculosis vaccine research. This effort has been made possible through the global collaboration between IAVI, Biofabri, and the University of Zaragoza, and the consortium of partners at the centers in South Africa, Kenya, and Tanzania. We are working toward a common goal: ending the devastating impacts of tuberculosis. It is an honor to be part of this coalition to accelerate the development of a new tuberculosis vaccine and ensure its equitable and affordable global distribution once it is authorized,” stated Ana Céspedes, Chief Operating Officer of IAVI.
The study will be conducted at the following clinical research centers: Kenya Medical Research Institute/Center for Respiratory Disease Research in Nairobi, Kenya; Victoria Biomedical Research Institute in Kisumu, Kenya; Institute of
Ifakara Health in Dar es Salaam, Tanzania; Aurum Institute in Rustenburg, South Africa; Aurum Institute in Tembisa, South Africa; Be Part Research in Paarl, South Africa; Centre for Infectious Disease Research in Africa, Cape Town, South Africa; JOSHA Research in Bloemfontein, South Africa; Perinatal HIV Research Unit, Soweto, South Africa; South African Tuberculosis Vaccine Initiative, Worcester, South Africa; Synergy Biomedical Research Institute, East London, South Africa; TASK Delft, Cape Town, South Africa; TASK Eden, George, South Africa; Cape Town Lung Institute – Centre for Tuberculosis Research, Cape Town, South Africa; and University of Cape Town Lung Institute – Centre for Lung Infection and Immunity, Cape Town, South Africa.
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 tuberculosis disease in adults and adolescents, for whom there is currently no effective vaccine. Two Phase 2 trials of MTBVAC have been completed: one sponsored by Biofabri and supported by the European and Developing Countries Clinical Trials Partnership in newborns in South Africa, and another sponsored by IAVI and supported by the U.S. National Institutes of Health and the U.S. Department of Defense through its Congressional Directed Medical Research Program. Results from both trials are expected to be published in 2025.
IAVI. IAVI is a non-profit scientific research organization with offices in the US, Europe, Africa, and India that develops vaccines and antibodies against HIV, tuberculosis, emerging infectious diseases, and neglected diseases, with the goal of providing global access. It has contributed to the evaluation of most of the leading tuberculosis vaccine candidates currently in clinical development and has a highly experienced clinical research team for tuberculosis vaccines in South Africa.
BIOFABRI. Biofabri is a biopharmaceutical company founded in 2008 with the goal of researching, developing, and manufacturing vaccines for humans. Biofabri has extensive technical and scientific capabilities in vaccines and immunotherapy. Biofabri belongs to the Zendal Group, a Spanish pharmaceutical company specializing in the development, manufacturing, and marketing of vaccines and other biotechnological products for human and animal health.
UNIVERSIDAD DE ZARAGOZA. The University of Zaragoza, Spain, is the leading center for technological innovation in the Ebro Valley. It participates in various exchange programs, collaborating with universities and research centers in Europe, Latin America, and the United States. Microbiologists from the university, in association with the Biomedical Research Networking Center for Respiratory Diseases (CIBERS), led the research and subsequent discovery of the experimental vaccine MTBVAC. Within the Tuberculosis Vaccine Initiative consortium, the discovery phase of MTBVAC included rigorous clinical characterization by independent laboratories and research groups.
