M72/AS01E
M72/AS01E is a tuberculosis vaccine candidate that is currently under development. It is composed of the M72 antigen, a fusion protein of two Mycobacterium tuberculosis antigens (MTB32A and MTB39A), and the AS01E adjuvant system. The vaccine is designed to protect against pulmonary tuberculosis in adults who are already infected with Mycobacterium tuberculosis, but who do not yet have active disease.
Development
The M72/AS01E vaccine candidate is being developed by GlaxoSmithKline (GSK) in partnership with Aeras, a non-profit organization dedicated to the development of tuberculosis vaccines. The development of the vaccine is based on the discovery of the M72 antigen, which is a fusion protein of two Mycobacterium tuberculosis antigens (MTB32A and MTB39A). The AS01E adjuvant system is used to enhance the immune response to the antigen.
Clinical Trials
Phase II clinical trials for M72/AS01E began in 2014. The results of these trials, published in 2018, showed that the vaccine was 54% effective in preventing active tuberculosis disease in adults who were already infected with Mycobacterium tuberculosis. The vaccine was well tolerated, with no serious adverse events reported.
Phase III trials are currently underway to further evaluate the safety and efficacy of the vaccine.
Potential Impact
If successful, M72/AS01E could have a significant impact on the global tuberculosis epidemic. Tuberculosis is one of the top 10 causes of death worldwide, and the leading cause from a single infectious agent. In 2018, an estimated 10 million people fell ill with tuberculosis, and 1.5 million died from the disease. A vaccine that could prevent active disease in those already infected could significantly reduce these numbers.
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