Our new paper “Blood-stage malaria vaccine candidate RH5.1/Matrix-M in healthy Tanzanian adults and children; an open-label, non-randomised, first-in-human, single-centre, phase 1b trial” has now been published in The Lancet Infectious Diseases.
This Phase Ib clinical trial (NCT04318002), assessed our most advanced clinical vaccine candidate, RH5.1 in Matrix-MTM in monthly or delayed third dose regimens in adults and children residing in a malaria-endemic setting for the first time.
The trial was conducted at Ifakara Health Institute, Bagamoyo, Tanzania and the vaccine candidate was shown to be safe and immunogenic, inducing highly promising humoral responses in 5-17 month old children, the target population for a malaria vaccine.
Notably, we report on improved responses with a delayed third dose as compared to monthly. In the children delayed third dose regimen cohort, we report the highest levels of functional growth inhibition activity seen in human trials to date, with all participants in this group achieving target threshold associated with protective outcome in non-human primates.
These data strongly support onward efficacy assessment of this candidate now underway in Burkinabe children.
