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

A pilot controlled human infection study will inoculate 10 healthy adults (18–45 years) with a 4-strain genetically modified Neisseria lactamica mixture expressing NadA and mutated FHbp variants.

• Why it matters: Prior work links experimental Neisseria lactamica colonisation to reduced meningococcal colonisation, but safety, colonisation induction, and immune responses for this specific GM-Nlac challenge remain to be established.
• What they did: Participants will receive intranasal inoculation with 4xrNlac and be followed for 28 days to measure colonisation, immunogenicity, and eradication after a single oral ciprofloxacin dose (500 mg).
• The result: The trial will evaluate whether this GM-Nlac challenge is safe and can induce colonisation and immune responses, while also assessing onward transmission via recruited participant contacts.

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