Arizona Tribune - IAVI and Biofabri/Zendal Announce First Vaccinations in the IMAGINE Clinical Trial, a Large-scale Safety and Efficacy Trial of the Tuberculosis Vaccine Candidate MTBVAC

NEW YORK, NY AND PORRIÑO, SPAIN / ACCESS Newswire / February 26, 2025 / IAVI, a global nonprofit scientific research organization, and the Spanish biopharmaceutical company Biofabri, a subsidiary of Zendal, today announced that the first doses of MTBVAC have been administered in the IMAGINE (Investigation of MTBVAC toward Accelerating Global Immunization for a Neglected Epidemic) clinical trial. The trial's first participants were vaccinated on February 19, 2025, at Be Part Research (Pty) Limited in Paarl, South Africa. The IMAGINE trial is a large-scale safety and efficacy clinical trial of the TB vaccine candidate MTBVAC. The study, sponsored by IAVI, is funded by Open Philanthropy, the Gates Foundation, and the German Federal Ministry of Education and Research through the KfW Development Bank.

The IMAGINE trial will assess the safety and efficacy of MTBVAC to prevent active TB lung disease in adolescents and adults. This Phase 2b trial is expected to enroll approximately 4,300 participants with latent TB infection across 15 sites in South Africa, Kenya, and Tanzania. Study participants will be followed for two to three years to assess the vaccine candidate's efficacy. MTBVAC is administered as a single dose via intradermal delivery.

"We are thrilled to see the launch of the IMAGINE trial," said IAVI President and CEO Mark Feinberg, M.D., Ph.D. "A new and efficacious vaccine against TB, the world's deadliest infectious disease, would have tremendous public health impact. This trial represents a very important milestone in global efforts to mitigate the terrible impact of the TB pandemic, and we are very grateful for the support of our funders and partners, and, importantly, the study volunteers who will participate in the IMAGINE trial."

TB disease caused 1.25 million deaths in 2023 and is widely recognized as the world's most lethal infectious disease. The only approved vaccine for TB, the Bacillus Calmette-Guérin (BCG) vaccine, was introduced over 100 years ago. The BCG vaccine provides partial protection to children but does not prevent TB disease in adolescents or adults. A TB vaccine effective in children, adolescents, and adults would save millions of lives otherwise lost to TB over time.

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). It is the only live-attenuated TB vaccine candidate derived from Mycobacterium tuberculosis in current 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 trials in adults and neonates and was shown to have either comparable or favorable immunogenicity and safety profiles at different doses as compared to BCG. Biofabri is also conducting a Phase 3 trial of MTBVAC in neonates in South Africa, Madagascar, and Senegal. Biofabri and the HIV Vaccines Trial Network are also conducting a Phase 2a trial evaluating the safety and immunogenicity of MTBVAC in people living with and without HIV that began in January 2024.

"The IMAGINE trial is an important new effort to develop a vaccine capable of combatting the world's deadliest disease," said Lewis Schrager, M.D., head of IAVI's TB vaccine development efforts. "Because MTBVAC is a single-shot vaccine we are hopeful that, if proven effective, MTBVAC could prevent millions of cases of TB disease, particularly in persons living in some of the world's most difficult-to-reach locations."

If MTBVAC is shown to be efficacious, Biofabri, IAVI, and other partners will work together to ensure there is a sufficient, affordable supply of MTBVAC available for low- and middle-income countries.

"Biofabri and its partners in Asia and South America will work together to help ensure a global supply of the vaccine," said Esteban Rodriguez, CEO of Biofabri.

"An effective vaccine is urgently needed for TB, historically the biggest killer of mankind, which results in 11 million newly diseased individuals every year. Besides the millions of resultant deaths, TB is also associated with substantial reductions in the gross domestic product of low- and middle-income countries, given that economically active young people are often affected by the disease. Even after effective treatment patients often suffer lung damage and scarring, and thus TB is the most common and important cause of lung disability in many TB endemic countries. Drug-resistant TB is an emerging threat to TB control that is difficult and more expensive to treat. I am therefore 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 Keertan Dheda, MBBCh, FCP, FCCP, Ph.D, FRCP, professor of respiratory medicine, director of the Centre for Lung Infection and Immunity, head of the Division of Pulmonology in the Department of Medicine at the University of Cape Town, and principal investigator for the IMAGINE trial.

"The IMAGINE trial is an exciting step forward for TB vaccine research. This effort has been made possible by a global collaboration between IAVI, our Spanish partners Biofabri and the University of Zaragoza, and our trial site partners in South Africa, Kenya, and Tanzania. We are working towards the same common goal: the end of the devastating impacts of TB disease. We are honored to be part of this coalition to ensure an accelerated R&D push for a new TB vaccine and its equitable, affordable global distribution once authorized," said Ana Céspedes, Pharm.D., MBA, and COO of IAVI.

The study will be conducted at the following clinical research sites: Kenya Medical Research Institute/Center for Respiratory Disease Research in Nairobi, Kenya; the Victoria Biomedical Research Institute in Kisumu, Kenya; Ifakara Health Institute in Dar es Salaam, Tanzania; The Aurum Institute in Rustenburg, South Africa; The Aurum Institute in Tembisa, South Africa; Be Part Research in Paarl, South Africa; Centre for Infectious Diseases Research in Africa, in Cape Town, South Africa; JOSHA Research in Bloemfontein, South Africa; Perinatal HIV Research Unit in Soweto, South Africa; South African Tuberculosis Vaccine Initiative in Worcester, South Africa; Synergy Biomedical Research Institute in East London, South Africa; TASK Delft in Cape Town, South Africa; TASK Eden in George, South Africa; University of Cape Town Lung Institute - Centre for Tuberculosis Research Innovation in Cape Town, South Africa; and the University of Cape Town Lung Institute - Centre for Lung Infection and Immunity in 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 TB 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 infants in South Africa, and one sponsored by IAVI and supported by the U.S. National Institutes of Health and the U.S. Department of Defense through its Congressionally Directed Medical Research Program. Results for both trials are expected to be published in 2025.

IAVI IAVI is a nonprofit scientific 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.

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

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 led the research and subsequent discovery of the experimental vaccine MTBVAC. Within the TuBerculosis Vaccine Initiative consortium, the MTBVAC discovery phase has included rigorous clinical characterization by independent laboratories and research groups.

IAVI Media Contact
Heather Teixeira
[email protected]

Biofabri Media Contact
Beatriz Diaz Lorenzo
[email protected]

SOURCE: IAVI

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T.Sanchez--AT