First vaccinee enrolled in the priMe trial
It is our pleasure to announce that the first participant has been enrolled on 9th of November 2020 in the priMe phase III trial to assess the efficacy and safety of the novel TB vaccine – VPM1002 - in comparison with BCG in healthy newborn infants.
The trial has been designed as a multicenter, randomized, double-blinded, active controlled clinical trial across clinical sites in Kenya, Uganda Tanzania, 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 the currently used BCG, which is the only vaccine currently available for immunization against tuberculosis. Participants enrolled will be randomized 1:1 to VPM1002 or BCG. The primary endpoint is to prove that VPM1002 prevents Mycobacterium tuberculosis infection at least as good as BCG.