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priMe completes recruitment for a large African trial on prevention of tuberculosis in neonates
Portrait of a happy mother and daughter enjoying a piggyback ride outdoors
For its pivotal phase III trial of the novel tuberculosis vaccine VPM1002, the priMe project has completed recruitment of all participants. The priMe trial is a large, double-blind phase III trial to evaluate the efficacy and safety of the novel tuberculosis vaccine candidate VPM1002 compared to BCG for the prevention of Mycobacterium tuberculosis infection in HIV-exposed and HIV-unexposed neonates. Participants enrolled will be randomised 1:1 to receive VPM1002 or BCG. The trial is being conducted in five African countries: Gabon, Kenya, South Africa, Tanzania and Uganda. The primary endpoint of the priMe trial is to prove that VPM1002 prevents Mycobacterium tuberculosis infection at least as good as BCG, inducing less side effects.