A First Clinical Trial for This Lifesaving Vaccine

The first clinical trial for a tuberculosis (TB) vaccine is taking place across five countries, and it could be the world’s first new TB vaccine in a century.

“In the long term, we have to make the vaccine available, accessible, and affordable,” said Alemnew Dagnew, who leads M72’s clinical development at Gates Medical Research Institute (MRI).

Twenty thousand volunteer participants will participate in the Phase 3 M72/AS01E vaccine study at 54 sites across five countries – Indonesia, Kenya, Malawi, South Africa, and Zambia – receiving the two-dose vaccine. The trial is funded by the Gates Foundation and the Wellcome Trust, and the vaccine’s development is led by the Gates MRI, the Foundation’s subsidiary. Its adjuvant, an ingredient that can supercharge the immune response a vaccine provokes, is provided by GlaxoSmithKline. Should the clinical trial be conclusive, it could be a new tool to reduce deaths and cut transmission of a global killer. The only TB vaccine known as BCG, which dates back to 1921, is effective with babies and young children but not among the elderly.