Tuberculosis (TB), a disease caused by bacteria called Mycobacterium tuberculosis, is one of the world’s deadliest communicable diseases. TB is spread from person to person through the air when a person with TB of the lungs or throat coughs, sneezes, or talks. Approximately 10.4 million people develop TB and 1.7 million die from the disease each year. Thanks to the discovery of antibiotics, TB has become a curable disease. However, TB remains one of the most serious infectious complications among immunocompromised patients, such as AIDS patients, transplantation patients, patients with TNF antagonist treatment. The emergence and outbreak of multidrug resistant strains also become a major challenge to treat this disease. In particular, Korea has one of the highest TB incidence and mortality rates among the OECD countries.

BCG (Bacille Calmette-Guerin) is the only licensed vaccine against TB. However, it provides insufficient protection against pulmonary TB primarily due to the lack of long-term protection. Therefore, it urgently requests the development of new vaccine strategy to replace or improve BCG.

Given the difficulty of clinical studies with infants, the development of BCG boosting vaccines is an ideal strategy for TB prevention.

QTP101 is a multiple-antigen protein fusion vaccine composed of three virulent antigens (Rv3619, Rv3620, Rv2608) and one latency-associated antigen (Rv1813) with GLA-SE (TLR4 agonist)-based adjuvant. This subunit vaccine shows enhanced safety and increased productivity through our manufacturing process development.

The efficacy of QTP101 as a BCG booster vaccine was verified in animal models. In addition, QTP101 has no cross-reactivity with the PPD skin test and the IGRA test, excluding the possibility of a false-positive reaction with these tests after the QTP101 vaccination.