IAVI, a global non-profit scientific research organization, and the Spanish biopharmaceutical company Biofabria subsidiary of the Zendal group, announced yesterday that the Bill & Melinda Gates Foundation has granted them 55 million dollars to carry out the Phase IIb trial that evaluates the safety and efficacy of the MTBVAC vaccine, a candidate against tuberculosis (TB).
This financing has been possible in part thanks to the subsidy provided by Open Philanthropy, a foundation that, with its resources, facilitates access to different lines of aid and/or donations.
This trial had also received additional funding from the German Federal Ministry of Education and Research (BMBF) through the KfW Development Bank, which provides financial support to IAVI and its partners for the development of MTBVAC. The trial is expected to begin recruiting participants in mid-2024.
“We are delighted to have secured funding to conduct the efficacy study of this promising vaccine,” said Mark Feinberg, president and CEO of IAVI.
“The world urgently needs a new effective vaccine that can prevent tuberculosis in adults and adolescents. We hope that MTBVAC is part of the solution to finally end this disease. “We are very grateful to the Bill & Melinda Gates Foundation and Open Philanthropy for their support of MTBVAC, whose visionary investment could accelerate the availability of MTBVAC within a few years, if it is proven safe and effective,” said Feinberg.
Additionally, senior leader of TB vaccine development efforts at IAVI, Dr. Lewis Schrager, said this is “a historic opportunity” to learn whether this “promising TB vaccine candidate can prevent the disease.” in adolescents and adults”, who are “the most likely to develop and transmit it”.
“If MTBVAC were proven to safely prevent tuberculosis disease in this portion of the population, this vaccine could be critically important in global strategies to eradicate tuberculosis, given its ease of use, low cost, and anticipated availability.” widespread,” he noted.
Previous studies
Previous Phase Ib/IIa studies of MTBVAC in adults and neonates demonstrated favorable immunogenicity and safety profiles, the company says.
In addition to this Phase IIb trial, Biofabri is currently conducting a Phase III trial of MTBVAC (NCT04975178) in neonates in South Africa, Madagascar and Senegal, with support from the European & Developing Countries Clinical Trials Partnership.
In parallel, Biofabri and the HIV Vaccine Trials Network are designing a Phase IIa trial (NCT0547890) to evaluate the safety and immunogenicity of MTBVAC in people with HIV treated with antiretroviral therapy. This trial is scheduled to begin in mid-January 2024 in South Africa.
To date, very few efficacy trials of candidate vaccines against tuberculosis have been conducted. Thus, this study of MTBVAC to prevent tuberculosis disease will be carried out in about 4,300 people with latent tuberculosis infection.
Participants will be between 14 and 45 years old and residents of South Africa and other countries in sub-Saharan Africa, areas with high TB burden. Participants from 15-20 different centers will receive a single dose of MTBVAC or placebo and will be observed for two to three years.
For his part, the director of IAVI Africa, Kundai Chinyenze, indicated that they are pleased to be able to start working on this efficacy trial in a region of the world where tuberculosis is one of the main causes of morbidity and mortality, especially for people who they live with HIV.
MTBVAC, designed by the Spanish researcher Carlos Martín, from the University of Zaragoza, and Dr. Brigitte Gicquel, from the Pasteur Institute, was licensed by Biofabri (Zendal Group).
The only tuberculosis vaccine currently available, Bacillus Calmette Guérin (BCG), comes from Mycobacterium bovis, the bacteria that causes a tuberculosis-like disease in cows.
For its part, MTBVAC is the only live attenuated vaccine derived from Mycobacterium tuberculosis – the bacteria that causes tuberculosis in humans – in the clinical trials phase. Because it is derived from human, and not bovine, M. tuberculosis, MTBVAC has the potential to generate a greater immune response against tuberculosis. The vaccine is administered in a single dose intradermally and does not require the use of adjuvants.
The CEO of Biofabri, Esteban Rodríguez, was also “grateful and excited”, pointing out that this opportunity allows them to “evaluate the effectiveness of MTBVAC in adolescents and adults, thanks to the enormous efforts of the IAVI and the valuable support provided by the Bill & Melinda Gates Foundation, Open Philanthropy and the German Federal Ministry of Education and Research (BMBF) through the KfW Development Bank.”
“The results of the efficacy studies in neonates, adolescents and adults will provide us with a way to authorize MTBVAC in all age ranges,” he detailed.
If the MTBVAC vaccine candidate is shown to be safe and effective, Biofabri, in partnership with IAVI and other collaborators, “will ensure that MTBVAC is manufactured and supplied in sufficient quantities worldwide and is accessible and affordable in the countries of low and middle income.”
From babies to adults
MTBVAC is being developed with two objectives: as a more effective and potentially longer lasting vaccine than BCG for newborns, and for the prevention of tuberculosis in adults and adolescents, for which there is currently no effective vaccine.
Two Phase II trials have been completed, one supported by EDCTP and sponsored by Biofabri (Zendal group) in South African infants, and another sponsored by IAVI and supported by the National Institutes of Health and the Department of Defense, both in the US. through the Congressionally Directed Medical Research Program. The results are expected to be published in late 2023.
2023-12-19 05:08:00
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