The clinical trials of MTBVAC, the Spanish tuberculosis vaccine, began among adults in India.

The trials of the first live attenuated vaccine of Mycobacterium tuberculosis isolated from a human are being carried out by an Indian pharmaceutical company in close collaboration with a Spanish biopharmaceutical company.

Trials to evaluate the safety and immunogenicity of MTBVAC have started with a pivotal safety, immunogenicity and efficacy trial planned to start in 2025, the companies said in a joint statement on March 24.

"After more than three decades of research, it is a giant step to test in adults and adolescents in the country where 28% of the world’s TB cases accumulate," said the CEO of the Spanish biopharmaceutical company.

The only vaccine in use today, BCG (Bacillus Calmette and Guérin), is an attenuated variant of the bovine TB pathogen. It is more than 100 years old and has a very limited effect on pulmonary tuberculosis, which is responsible for the transmission of the disease.

The companies hope that the new vaccine will be a milestone in global vaccinology and called it an example of public-private, national and international collaboration.

After the completion of a Phase2 dose-finding trial the MTBVAC vaccine, a double-blind, controlled Phase3 clinical trial in newborns started in 2023, comparing the vaccine with the current BCG vaccine. 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal will be vaccinated. To date, more than 1,900 babies have been vaccinated.

The aim is to assess the immunogenicity and efficacy of MTBVAC which is administered intradermally to infants on the first day of life.

Health restrictions imposed during the COVID-19 pandemic led to an increase in infections and a decrease in diagnosis and treatment. As a result, annual TB deaths have risen to over 1.6 million.

This Phase3 neonatal project is being coordinated by Biofabri, as part of a consortium.

After completing a dose escalation trial in HIV uninfected adults, a Phase2 study in HIV-infected adults has started in 2024 to determine whether MTBVAC is safe in this population. This ongoing trial at 16 sites in South Africa – involving the vaccination of 276 adults – is evaluating safety and immunogenicity in HIV-negative and HIV-positive adults and adolescents vaccinated with MTBVAC.