The GM-Nlac Study - Pilot
Research type
Research Study
Full title
Safety, colonisation and immunogenicity following nasal inoculation with genetically modified Neisseria lactamica expressing Factor H binding protein and Neisseria adhesin A - a pilot controlled human infection study
IRAS ID
364569
Contact name
Adam P Dale
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
10 years, 2 months, 30 days
Research summary
This study is part of a research programme that aims to improve ways of protecting people from meningitis and sepsis caused by a bacterium called Neisseria meningitidis (Nmen). These are serious illnesses which mainly affect young children and adolescents both in the UK and globally, particularly in areas of Sub-Saharan Africa. Nmen meningitis and sepsis can rapidly cause death or serious disability, and improving strategies to prevent these illnesses are one pillar of the World Health Organisation vision “Defeating meningitis by 2030”.
Neisseria lactamica (Nlac) is a closely related but harmless bacterium. In previous studies, controlled human infection of healthy adults with unmodified Nlac has resulted in colonisation which is immunogenic and reduces colonisation with Nmen. Genetic modification of Nlac to express proteins from Nmen may improve this immune response and protection from colonisation.
In this research programme we will aim to induce nasopharyngeal colonisation with one or more of four strains of genetically-modified Nlac (GM-Nlac). Each strain expresses two meningococcal antigens. The four strains will be administered in approximately equal proportions in a challenge agent known as “4xrNlac”.
This study is designed as a pilot study to establish the safety and colonisation potential of controlled human infection with 4xrNlac in a small cohort of participants, with an open-label study design. Early immunological data will be assessed, and participant samples will be used to optimise microbiological and immunological assays. Efficacy of antibiotic clearance will also be assessed.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
26/SC/0072
Date of REC Opinion
12 Mar 2026
REC opinion
Favourable Opinion