The MTBVAC vaccine candidate has advanced toward universal tuberculosis prevention. Now in clinical testing, it shows greater efficacy than the sole existing vaccine, BCG.
Tuberculosis (TB) is caused by Mycobacterium tuberculosis, known as Koch's bacillus. It spreads through airborne droplets from prolonged close contact with infected individuals coughing or sneezing. TB remains a major global health crisis, with a new infection every second worldwide. About 90-95% of infected people never develop active disease, as their immune systems control it.
However, over 10 million develop active TB annually, leading to roughly 1.4 million deaths. Africa and Southeast Asia are hardest hit. In France, around 5,500 new cases occur each year, resulting in nearly 700 deaths.
While antibiotics can treat TB, vaccination offers prevention. BCG is the only approved vaccine, but its protection is limited, mainly preventing severe childhood forms.
For years, researchers at the University of Zaragoza have developed MTBVAC—the first vaccine using a live attenuated strain of the human pathogen Mycobacterium tuberculosis, unlike BCG derived from bovine M. bovis.
MTBVAC has reached a key milestone as a universal TB vaccine candidate. It proved safe in phase 1 trials with adults in Switzerland and phase 1b with newborns in South Africa. Phase 2 trials are underway in TB-naïve adults and healthy neonates to optimize dosing and assess safety and immunogenicity on a larger scale.
In recent research, rhesus macaques received intradermal MTBVAC, providing significantly better protection against aerosol M. tuberculosis challenge than BCG (same dose and route).
This builds on prior preclinical and clinical data on safety, immunogenicity, and efficacy, offering strong proof-of-concept. MTBVAC could emerge as a superior alternative to BCG against human respiratory TB.
