GSK’s Trump Card: Vaccine for Tuberculosis

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British drug maker GlaxoSmithKline (GSK) has developed a vaccine to fight against Tuberculosis. Tuberculosis – better known as TB is a deadly, infectious disease. It has become a major cause of concern with about 1.5 million attributed deaths in 2018. Thus, medical advancement and newer technologies to prevent such disease are the need of the hour. For the first time now, GSK has taken a major step towards finding a potential new vaccine against the lethal disease.

GSK manufactures products for major disease areas such as asthma, cancer, infections, diabetes, and mental health apart from its consumer health portfolio. It developed the first-ever licensed malaria vaccine which was approved for use by European regulators in July 2015. And now, the firm’s clinical trial for the vaccine M72/AS01E has concluded with promising results.

M72/AS01E is a candidate vaccine that contains the M72 recombinant fusion protein, derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A), combined with the Adjuvant System AS01.

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Sponsor GSK conducted a study in partnership with IAVI which is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis.

The study was conducted to investigate if the M72/AS01E candidate vaccine prevents adults with latent Mycobacterium tuberculosis infection from developing pulmonary tuberculosis. Along with this, the safety, reactogenicity and immunogenicity parameters were also studied.

The study was a phase IIb, multicentre, randomised, double-blind, placebo-controlled study comparing the candidate vaccine M72/AS01E to a placebo in a 1:1 ratio. The trial was conducted at 11 sites in TB-endemic regions including Kenya, South Africa and Zambia. It involved 3,573 HIV-negative adults between the ages of 18 and 50 years.

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Study’s primary results were published in September 2018 in the New England Journal of Medicine. On October 29th, the final analysis of the study was published and confirmed the previously reported clinically acceptable safety profile of the vaccine. The vaccine significantly reduced the incidence of pulmonary tuberculosis disease (TB) in HIV-negative adults with latent TB infection. There was an overall vaccine efficacy of 50% during the three years of vaccination. The safety and reactogenicity profile were also found out to be acceptable.

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TB is the leading cause of death primarily in the developing countries. It is a public health threat due to its lethal impact and needs to be curbed down. Emerging Multi-drug resistant strains of the disease are also spreading globally only worsening the existing conditions. Pulmonary tuberculosis, which affects the lung, is responsible for the spread of the disease from person-to-person.  Though there is only one existing BCG (Bacillus Calmette–Guérin) vaccine catering to some limited forms of TB in children less than five years of age, a proven and consistent solution to provide protection against pulmonary tuberculosis is yet to be developed.

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There is a need for some additional trials to be conducted to confirm the findings in other populations. But what remains a fact is no other alternative has ever been developed that provides protection in adults who are already infected with the bacteria that causes tuberculosis. Therefore, with such a grim situation, when even a partially effective vaccine might do wonders; the results of this study could be a game-changer in the fight against pulmonary tuberculosis.

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