GSK’s tuberculosis vaccine shows efficacy over three years in HIV negative patients
pharmafile | October 29, 2019 | News story | Manufacturing and Production, Research and Development | GSK, IAVI, Vaccine, pharma, tuberculosis
Promising results have been revealed from a GlaxoSmithKline study, conducted in partnership with non-profit scientific research organisation IAVI, investigating the efficacy of the company’s M72/AS01E tuberculosis (TB) vaccine in HIV-negative adults with latent TB infection.
The study was conducted across 11 sites throughout Kenya, South Africa and Zambia – all TB-endemic regions – enrolling 3,573 HIV-negative participants between 18 and 50 years old. These participants were randomised to receive two doses, 30 days apart, of either the vaccine candidate or placebo and were monitored for three years.
It was found that, following final analysis, 13 vaccine recipients developed active pulmonary TB compared to 26 placebo recipients, with the vaccine recipients exhibiting an increased M72-specific immune response for the duration of the three-year monitoring period with an overallvaccine efficacy of 50%. The vaccine was also found to present an acceptable safety and reactogenicity profile, in line with previous studies.
“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,” remarked 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.”
Dr Mark Feinberg, President and CEO of IAVI, also commented on the data: “These final results show that M72/AS01E could be an important tool in the fight against pulmonary tuberculosis. 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 tuberculosis.”
Matt Fellows
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