Candidate vaccine shows sustained protection against pulmonary TB - European Pharmaceutical Review

A candidate TB vaccine’s efficacy level and acceptable safety profile have been confirmed in a three-year clinical trial.

It has been reported that GlaxoSmithKline’s (GSK’s) M72/AS01_E  candidate vaccine has significantly reduced the incidence of pulmonary tuberculosis disease (TB) in HIV-negative adults with latent TB infection.

These results demonstrate an overall vaccine efficacy of 50 percent during the three years after vaccination and the candidate vaccine has an acceptable safety and reactogenicity profile. The final results are consistent with the primary analysis done after two years of follow-up.

“These results demonstrate that for the first time in almost a century, the global community potentially has a new tool to help provide protection against TB,” said Dr Thomas Breuer, Chief Medical Officer of GSK Vaccines. “I want to thank our scientists for their dedicated effort and scientific innovation in developing this impactful vaccine candidate in partnership with IAVI and other key organisations.”   

The trial was conducted in TB-endemic regions (Kenya, South Africa and Zambia) and involved 3,573 HIV-negative adults between the ages of 18 and 50 years. Participants who received two doses of either M72/AS01_E or placebo 30 days apart were followed for three years to detect evidence of pulmonary TB disease.

We have never before seen a vaccine that provides protection in adults who are already infected with the bacteria that cause TB”

In the final analysis, 13 participants in the vaccine group developed active pulmonary TB compared to 26 participants in the placebo group. Among participants who received the vaccine, an increased M72-specific immune response was sustained through three years.  

“These final results show that M72/AS01_E could be an important tool in the fight against pulmonary TB,” added Dr Mark Feinberg, President and CEO of IAVI. “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 results of the study were published in the New England Journal of Medicine.

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