Protocol for a controlled human infection with genetically modified Neisseria lactamica expressing the meningococcal vaccine antigens NadA and FHbp: The GM-Nlac Pilot Study

Introduction Previous work has shown that experimentally induced colonisation with Neisseria lactamica (Nlac) is safe and associated with reduced meningococcal colonisation. This pilot study aims to establish the safety, induction of colonisation and immunogenicity following intranasal inoculation with a mixture of four strains of genetically modified Nlac (GM-Nlac). Each of these strains express meningococcal vaccine antigens present in current vaccines: Neisseria adhesin A (NadA) and one of four different variants of Factor H-binding protein (FHbp), the latter of which is specifically mutate

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