(MENAFN-IANS) Hyderabad, March 24 (IANS) Clinical trials of MTBVAC, the Spanish tuberculosis vaccine, have begun in adults in India.
Bharat Biotech is conducting trials of the first attenuated vaccine against Mycobacterium tuberculosis isolated from humans in close collaboration with Biofabri, a Spanish biopharmaceutical company.
Trials to compare the protection and immunogenicity of MTBVAC have begun with a pivotal protection, immunogenicity and efficacy trial expected to begin in 2025, the corporations said in a joint statement on Sunday.
“After more than 3 decades of research, it is a giant leap forward for adults and adolescents in a country where 28% of the world’s tuberculosis cases are accumulated,” said Esteban Rodríguez, CEO of Biofabri.
The only vaccine used today, BCG (Bacillus Calmette and Guérin), is an attenuated variant of the bovine tuberculosis pathogen. It is more than a hundred years old and has a very limited effect on pulmonary tuberculosis, which is responsible for the transmission of the disease. disease. Corporations hope that the new vaccine will mark a milestone in global vaccinology and consider it an example of public-private collaboration, domestic and foreign.
“Our search for a more effective TB vaccine has gained great momentum today, with clinical trials in India. Our goal to develop TB vaccines to save the disease in adults and adolescents has taken a big step forward today. “We are revered for collaborating with BioFabri, Dr. Esteban Rodriguez and Dr. Carlos Martin in this noble effort to reinvent TB vaccines,” said Krishna Ella, Executive Chairman of Bharat Biotech.
Following the final touch of a Phase 2 dose-finding trial for the MTBVAC vaccine, a Phase 3, double-blind, controlled clinical trial in newborns began in 2023, comparing the vaccine to the existing BCG vaccine. 7,000 newborns from South Africa, 60 60 children 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.
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 risen to more than 1. 6 million.
This Phase 3 neonatal project, funded through the European Union through its EDCTP (European Union
After completing a dose-escalation trial in HIV-uninfected adults, a phase 2 study in HIV-infected adults began in 2024 to determine if MTBVAC is safe in this population. This ongoing trial at 16 sites in South Africa – involving the vaccination of 276 adults – is comparing protection and immunogenicity in HIV-negative and HIV-positive adults and adolescents vaccinated with MTBVAC.
MENAFN24032024000231011071ID1108014466
Keywords
commentary
Category
Date