GlaxoSmithKline on Tuesday announced the final analysis of a Phase IIb study showing that the candidate vaccine M72/AS01E significantly reduced the incidence of pulmonary tuberculosis (TB) disease in HIV-negative adults with latent TB infection. The results, which were published in the NEJM and presented at the Union World Conference on Lung Health, demonstrated an overall vaccine efficacy of 50% during the three years after vaccination.
Thomas Breuer, chief medical officer of GlaxoSmithKline's vaccines unit, commented that "for the first time in almost a century, the global community potentially has a new tool to help provide protection against TB." Meanwhile, Mark Feinberg, CEO of the non-profit scientific research organisation IAVI, which helped conduct the study, said "while additional trials need to be conducted to confirm these findings in other populations, we have never before seen a vaccine that provides protection in adults who are already infected with the bacteria that cause TB."
The study was conducted in the TB-endemic regions of Kenya, South Africa and Zambia, and involved 3573 HIV-negative adults between the ages of 18 and 50 years. Participants were randomised to receive two doses of either M72/AS01E or placebo 30 days apart and were then followed for three years to detect evidence of pulmonary TB disease. The trial's primary objective was to investigate if M72/AS01E prevents adults with latent Mycobacterium tuberculosis infection from developing pulmonary TB disease.
Primary results from the study after two years of follow-up were published last year, with GlaxoSmithKline noting Tuesday that in the final analysis, 13 participants in the vaccine group developed active pulmonary TB compared to 26 participants on placebo. The company added that among those who received the vaccine, an increased M72-specific immune response was sustained through three years. The drugmaker also indicated that final results confirmed the previously reported "clinically acceptable" safety profile of M72/AS01E.
The vaccine contains the M72 recombinant fusion protein, which is derived from the M. tuberculosis antigens Mtb32A and Mtb39A, combined with the adjuvant system AS01.
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