16 July 2021 - - Spanish biopharmaceutical company Biofabri and IAVI, an international nonprofit research organization focused on developing vaccines and antibodies against infectious and neglected diseases, plan to partner on efficacy trials of the tuberculosis vaccine candidate MTBVAC, the principals said.

The candidate, designed by the Spanish researcher Dr. Carlos Martin from the University of Zaragoza, was in-licensed and is being manufactured and developed by Biofabri, a subsidiary of the Zendal Group, in collaboration with University of Zaragoza, IAVI, and Europe-based Tuberculosis Vaccine Initiative.

MTBVAC will complete Phase II evaluation this year and is one of the most promising new TB vaccines in the pipeline. 

The only available TB vaccine, bacille Calmette-Guérin, does not prevent primary infection and has limited effectiveness at preventing pulmonary TB in adults, who, along with adolescents, are mainly responsible for spreading TB.

The first dose of the BCG vaccine was delivered 100 years ago to the day Sunday, July 18.

This announcement comes amidst the extraordinary pace of the development of numerous vaccines to protect people from COVID-19 over the past year.

The European and Developing Countries Clinical Trials Partnership (EDCTP) has committed to support a Phase III trial of MTBVAC in newborns, scheduled to begin in several African countries in 2021.

IAVI will support the development and further resource mobilization for MTBVAC, including for an adolescent/adult trial.

TBVI will also support the ongoing trial preparations.

Should MTBVAC be shown to be safe and efficacious, Biofabri in partnership with IAVI will ensure that MTBVAC is manufactured and supplied in sufficient quantities to neonates, infants, adolescents, and adults and is accessible at affordable prices in low- and middle-income countries.

TB has been the biggest infectious disease killer in the world, killing an estimated 1.4 m people each year, 10% of whom are children. These numbers have been surpassed only by COVID-19 in the past two years.

Around 10 m people fell ill with tuberculosis in 2019, and the disease is one of the 10 leading causes of death worldwide.

COVID-19 has reversed previous advances in TB response by 10 years, causing significant decreases in TB case detection. The Stop TB Partnership estimates that an additional 1.4m TB deaths will occur over the next four years because of COVID-19. A vaccine is more urgent than ever.

Drug-resistant/multi-drug resistant TB (DR/MDR TB) is becoming an increasing problem, with about 465,000 cases in 2019. DR/MDR TB treatment is arduous, expensive, and not always successful. A vaccine that prevents TB disease would have a major impact on the DR/MDR TB problem.

MTBVAC is the only live attenuated Mycobacterium tuberculosis vaccine in development.

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

Two Phase II trials are ongoing, one supported by EDCTP and sponsored by Biofabri in infants in South Africa, and one sponsored by IAVI and supported by the US National Institutes of Health and the US Department of Defense through its Congressionally Directed Medical Research Program. Results are expected late 2021.

A study published in early 2021 (White et al., NPJ Vaccines 2021) showed that a single dose of MTBVAC provides significantly better protection against aerosol exposure to Mycobacterium tuberculosis in rhesus macaques compared to BCG at the same dose.

This confirms that the immunological responses induced after vaccination with MTBVAC in rhesus macaques reflect those in Phase I clinical trials of MTBVAC.

Biofabri considers IAVI a crucial partner for the end-to-end development of this important vaccine candidate as the partners embark on efficacy studies for both the neonatal/infant and adolescent/adult indications.

IAVI will support Biofabri in access planning for the neonatal/infant indication and the development and implementation of the adolescent and adult studies. The partners are actively seeking funders to support clinical development for the adolescent/adult indication.