MTBVAC, the world’s first tuberculosis vaccine derived from a human source, has commenced clinical trials in India. This significant milestone aims to address the urgent need for effective TB prevention and treatment.
The initiation of clinical trials for MTBVAC in India marks a remarkable milestone—Bharat Biotech International Limited in collaboration with Biofabri have started a series of clinical trials to evaluate the safety, immunogenicity and efficacy of MTBVAC in India.
MTBVAC is being developed for two purposes: as a more effective and potentially longer-lasting vaccine than BCG for newborns, and for the prevention of TB disease in adults and adolescents, for whom there is currently no effective vaccine.
MTBVAC is the only vaccine against tuberculosis in clinical trials based on a genetically modified form of the pathogen isolated from humans Mycobacterium tuberculosis which, unlike BCG, contains all the antigens present in strains that infect humans.
This vaccine was developed in the laboratory of the University of Zaragoza, which has been part of CIBERES since its creation, in collaboration with Dr Brigitte Gicquel of the Pasteur Institute in Paris. The University of Zaragoza has the Spanish biotechnology company BIOFABRI as an industrial partner.
MTBVAC Vaccine: Advancing Tuberculosis Research
Tuberculosis (TB) remains a formidable adversary, claiming over 1.6 million lives annually worldwide. India, with its staggering TB burden, plays a central role in the fight against this infectious disease. The clinical trials of MTBVAC on Indian soil hold immense importance because they pave the way for a more effective and urgently needed vaccine.
MTBVAC’s clinical trials in India are pivotal for several reasons:
Dual Purpose: New Hope for Newborns and Adults
MTBVAC serves a dual purpose. First, it seeks to enhance protection for newborns, surpassing the effectiveness of BCG. Second, it targets TB prevention in adults and adolescents—a critical area where no effective vaccine currently exists. By evaluating its safety, immunogenicity, and efficacy, we unlock the potential to save countless lives.
- Safety and Efficacy: Bharat Biotech International Limited, in collaboration with Biofabri, is spearheading the trials. Researchers will meticulously study the safety, immunogenicity, and efficacy of the new TB Vaccine Candidate in adults—a critical step toward its potential approval.
- Human-Derived Innovation: MTBVAC represents a breakthrough. Unlike the current BCG vaccine, which has limitations, the TB Vaccine Candidate is derived from Mycobacterium tuberculosis isolated from a human source. It aims to provide better protection and potentially longer-lasting immunity.
World Tuberculosis Day
As we commemorate World Tuberculosis Day on March 24, 2024, the urgency to combat TB becomes even more evident. Esteban Rodriguez, CEO of Biofabri, emphasizes the significance of testing MTBVAC in India: “It is a giant step to evaluate this vaccine in the country where 28% of the world’s TB cases accumulate.” However, he underscores the need for continued efforts and funding to tackle this persistent threat.
Dr. Krishna Ella, Executive Chairman Bharat Biotech added, “Our quest for a more effective vaccine against Tuberculosis received a big boost today, with clinical trials in India. Our goal to develop TB vaccines to prevent disease in adults and adolescents has taken a big step today. We are honoured to partner with BioFabri, Dr. Esteban Rodriguez and Dr. Carlos Martin in this noble effort to reinvent TB vaccines.” A long process, an example of public-private collaboration. The MTBVAC vaccine has passed several milestones before entering clinical trials in India.
MTBVAC’s journey from research labs to clinical trials signifies hope—paving way for a future where TB no longer claims lives. As India takes center stage in this critical endeavor, the world watches with anticipation, hoping that MTBVAC will be the game-changer we desperately need.
Note: MTBVAC’s pivotal safety, immunogenicity, and efficacy trial is scheduled to begin in 2025.
Remember, together, we can eradicate TB and build a healthier world.
