BioNTech begins Phase I study of vaccine candidate for Malaria
ioNTech has commenced a first-in-human Phase I study of the first candidate from its malaria vaccine programme BNT165, BNT165b1.
The company aims to develop the first mRNA-based vaccine to prevent Malaria using a new multi-antigen vaccine method.
Initially, it will assess a set of mRNA-encoded antigens of the malaria-causing parasite Plasmodium falciparum (P. falciparum) for identifying the multi-antigen vaccine candidate that will proceed into the planned later-stage studies.
The first clinical study has been designed for assessing the tolerability, exploratory immunogenicity, and safety of BNT165b1, which expresses certain circumsporozoite protein (CSP) parts.
Nearly 60 healthy people with no history of previous or current malaria infection are expected to be enrolled at US sites in the observer blinded, placebo-controlled Phase I dose escalation trial.
In the trial, BNT165b1 will be assessed at three dose levels.
BioNTech chief medical officer and co-founder
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