Hyderabad: Clinical trials of MTBVAC, the Spanish tuberculosis vaccine, the first live attenuated vaccine against Mycobacterium tuberculosis isolated from humans, have begun in India, the most populous country in the world and with the highest number of cases of the disease.
The trials are carried out through Bharat Biotech in close collaboration with Biofabri. Trials to compare the protection and immunogenicity of MTBVAC have begun with a pivotal protection, immunogenicity and efficacy trial expected to begin in 2025.
After more than 3 decades of research, Esteban Rodríguez, CEO of Biofabri, says: “It is a giant leap to control adults and adolescents in a country where 28% of the world’s tuberculosis cases accumulate and concludes that more efforts and investments are needed. “to combat tuberculosis, which remains one of the leading infectious causes of death worldwide, especially in India.
Dr Krishna Ella, Executive Chairman of Bharat Biotech, added: “Our quest for a more effective TB vaccine has gained wonderful momentum thanks to clinical trials in India. Our goal to create TB vaccines to save the disease in adults and adolescents has reached a milestone. We are revered for collaborating with BioFabri, Dr. Esteban Rodríguez, and Dr. Carlos Martín in this noble effort to reinvent TB vaccines.
According to the statement, the MTBVAC vaccine has passed several milestones before entering clinical trials in India. The first is that following the recent finishing touch of a Phase 2 dose-finding trial, a Phase 3, double-blind, controlled clinical trial in newborns was initiated. began in 2023, comparing the vaccine to the existing BCG vaccine. 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal will be vaccinated. To date, more than 1,900 young children have been vaccinated. The aim is to compare the immunogenicity and efficacy of MTBVAC given intradermally to infants on the first day of life.
Immunization began at a time of setback in the global fight against TB. The health restrictions imposed by the COVID-19 pandemic have led to an increase in infections and a reduction in diagnoses and treatments. As a result, the annual number of TB deaths has increased. increased to more than 1. 6 million.
This Phase 3 neonatal project, funded through the European Union through its EDCTP (European Union
“Another important milestone is that, after completing a dose-escalation trial in HIV-uninfected adults, a phase 2 study in HIV-infected adults was initiated in 2024 to determine whether MTBVAC is safe in this population. This ongoing trial at 16 sites in southern Africa, involving the vaccination of 276 adults, is comparing protection and immunogenicity in HIV-negative and HIV-positive adults and adolescents vaccinated with MTBVAC,” he said.
Phase 2b efficacy in adolescents and adults is expected to begin in the second half of 2024 in sub-Saharan Africa.
Studies in adolescents and adults in sub-Saharan Africa are led by the U. S. -based IAVI institution. In the U. S. The Phase 2 HIV Protection Study is conducted through the HIV Vaccine Trials Network (HVTN) and is funded by the Department of AIDS (DAIDS). the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), the Department of Health and Human Services (DHHS). The Phase 2b efficacy study will be conducted through IAVI and will be funded through BMGF and Open Philanthropy.
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Ruchika Sharma joined Medical Dialogue as a business editor in 2019. It covers all updates in pharmaceuticals, politics, insurance, fitness, medical news, fitness news, pharma news, fitness, and investments. He received his B. Com from Delhi University and then pursued postgraduate studies in M. Com. She can be reached at editorial@medicaldialogues. in Contact Number 011-43720751
Dr. Kamal Kant Kohli-MBBS, DTCD: A chest specialist with over 30 years of practice and skill in writing clinical articles, Dr. Kamal Kant Kohli has joined Medical Dialogues as editor-in-chief of Medical News. articles, as editor, proofreads and verifies all medical content published in Medical Dialogues, adding those from journals, studies, medical conferences, guidelines, and more. Email: éditorial@medicaldialogues. in. Contact Number. 011-43720751
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