BCG Vaccine - The Only Vaccine Currently Available Against TB
The Bacillus Calmette–Guérin (BCG) vaccine is currently the only vaccine available for TB. It was first used in 1921 and offers some protection against severe forms of TB like TB meningitis or miliary TB in children. However, its effectiveness in preventing pulmonary TB in adults is limited. BCG vaccine efficacy varies from 0% to 80% depending on the population and study design. There has been limited success in boosting the efficacy of BCG with second generation vaccines.
New Tuberculosis Vaccine in Clinical Trials Hoping to Overcome BCG's Limitations
Several vaccines are currently in clinical trials hoping to overcome the limitations of BCG. These new vaccines target adults and adolescents to prevent pulmonary TB. Some key vaccines in clinical trials include M72/AS01E, VPM1002, DAR-901 and H56:IC31. M72/AS01E has shown 54.0% efficacy in preventing active TB in a phase 2b trial. VPM1002, a live mycobacterial vaccine, has completed phase 2a testing showing good safety and immunogenicity. DAR-901 uses a recombinant protein from M. tuberculosis and adenovirus vector to trigger immune response. Phase 1 and 2 trials showed it has a good safety profile and immunogenic. H56:IC31 uses an array of M. tuberculosis antigens combined with IC31 adjuvant and has completed phase 1 and 2 trials showing promise.
mRNA Tuberculosis Vaccine - A Novel Approach with Potential for Sterilizing Immunity
Novel mRNA vaccine platforms offer a new approach for Tuberculosis Vaccine with potential to induce stronger and longer lasting immunity compared to other platforms. mRNA vaccines work by getting the body's own cells to produce pathogen antigens. This more closely mimics natural infection and has potential to induce sterilizing immunity, needed to cure TB. Early studies from Moderna, BioNTech and others have shown mRNA vaccines can trigger both antibody and T-cell responses against TB. Moderna is developing an mRNA vaccine (mRNA-1654) for latent TB which is advancing well in preclinical studies. If successful, it could provide life-long protection after a single dose and cure latent TB.
Partnerships Accelerating Development of New TB Vaccines
Given the urgency to develop more effective vaccines, partnerships have accelerated efforts. The TB Vaccine Partnership brings together 10 organizations including the Bill and Melinda Gates Foundation to coordinate research. The partnership recently launched the Phase III Efficacy Study for M72/AS01E vaccine. The South African Tuberculosis Vaccine Initiative is testing H56/IC31 vaccine in South African adolescents. Grants from National Institute of Allergy and Infectious Diseases, European Commission and others support collaborations between research institutions, biotechs and non-profits. These partnerships provide funding, expertise and infrastructure crucial for advancing new vaccines through clinical trials. Their involvement has increased hope that a safe, effective new TB vaccine may soon become available to help fight the global epidemic of this airborne disease.
Progress Towards An Effective Tuberculosis Vaccine Still Faces Challenges
While progress has been made, developing an effective vaccine against an airborne disease like TB that easily spreads from person to person poses huge technical challenges. Conducting large phase 3 efficacy studies needed to prove protection against pulmonary TB costs hundreds of millions. Manufacturing new TB vaccines at global scale requires building capacity. Ensuring communities with highest TB burden have access will require subsidies. Achieving WHO targets will need a vaccine with efficacy above 70-80%. Getting high efficacy from a single dose vaccine may be difficult. Research is ongoing to find immune correlates of protection that can accelerate trials. With sustained funding and partnerships, the goal of ending TB deaths and disease by 2030 remains in reach if a safe, effective new vaccine is available in time.'
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