Health
Clinical trials of Spanish tuberculosis vaccine MTBVAC begin in India
Vaccine maker Bharat Biotech is conducting the trial in partnership with Spanish biopharmaceutical company Biofabri.File
Clinical trials of the Spanish tuberculosis (TB) vaccine MTBVAC have begun in India.
Vaccine maker Bharat Biotech has partnered with Spanish biopharmaceutical company Biofabri, which is responsible for the clinical and industrial development of the vaccine, which was developed in its laboratory at the University of Zaragoza along with Dr. Brigitte Gicquel of the Institut Pasteur in Paris, for the trial. are being carried out.
MTBVAC is the only vaccine against tuberculosis in clinical trials that is based on a genetically engineered pathogen of Mycobacterium tuberculosis isolated from humans. This vaccine, unlike the BCG vaccine, contains all the antigens present in the strains that infect humans. Trials to assess the safety and immunogenicity of MTBVAC have begun in India, with pivotal safety, immunogenicity and efficacy trials planned for 2025, Bharat Biotech said in March. This was announced in conjunction with World Tuberculosis Day on the 24th.
As Biofabri has completed phase 1 and phase 2 trials in other countries, Bharat Biotech will conduct phase 3 trials, a spokesperson said in response to a question.
“Our quest for a more effective vaccine against tuberculosis received a major boost today with clinical trials in India. The MTBVAC vaccine has passed several milestones before entering clinical trials in India.” said Executive Chairman Krishna Ella in a release.
Studying the vaccine's safety, immunogenicity, and efficacy in countries with the largest populations and highest numbers of infectious disease cases will be key to continued progress with this vaccine. The Hyderabad-based company said MTBVAC is being developed as a more effective and potentially longer-lasting vaccine than BCG for the prevention of tuberculosis in newborns and adults and adolescents, but there is currently no effective vaccine. said.
“Testing adults and adolescents in this country, where 28% of the world's tuberculosis cases are concentrated, is a major step,” said Biofabri CEO Esteban Rodríguez. BCG is an attenuated variant of the bovine tuberculosis pathogen that has been around for more than 100 years and has limited effectiveness against pulmonary tuberculosis, which is responsible for the transmission of the disease, he said.
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