Milestone achieved: Initiation of all clinical centers for a large African trial against tuberculosis in neonates completed
We are pleased to announce that a major milestone in the pivotal phase III trial (trial name: priMe) of the novel tuberculosis vaccine VPM1002 has been achieved with the completed initiation of all clinical trial centers.
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 randomized 1:1 to receive VPM1002 or BCG.
The trial is being conducted in five African countries, Kenya, Tanzania, Uganda, South Africa and Gabon.
VPM1002, manufactured by Serum Institute of India Pvt. Ltd. (SIIPL), who are also the sponsor of the clinical trial, is a recombinant vaccine against tuberculosis with an improved immunogenicity and safety profile compared to BCG, which is currently the only vaccine available for immunization against tuberculosis. 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.