Application for consent to release a GMO – organisms other than higher plants: Experimental challenge of the human nasopharynx with recombinant Neisseria lactamica expressing the meningococcal type V autotransporter protein, Neisseria Adhesin A (NadA).

Abstract

The purpose of the genetic modification is to construct a strain of the exclusively human, nasopharyngeal commensal bacterium, Neisseria lactamica (Nlac) that expresses on its surface the outer membrane protein, Neisseria Adhesin A (NadA). NadA is an adhesin protein found in the close relative of Nlac, Neisseria meningitidis (Nmen), which is the causative agent of meningococcal disease. The genetically modified organism (GMO) will be used to investigate the role of NadA in the colonisation of the nasopharynx and associated immune responses in a controlled human bacterial challenge. The Experimental Human Challenge group, previously based at the University of Sheffield and now located at the University of Southampton, has conducted two previous human bacterial challenges in adult volunteers, using wild type Nlac strain, Y92-1009. The primary objective of the proposed study is to verify that nasopharyngeal challenge of humans with GM-Nlac is safe. Secondary objectives are determining the impact of NadA expression on the frequency of nasopharyngeal colonisation by GM-Nlac and the type(s) of immune responses generated locally and systemically to these bacteria. Ultimately this strategy may confer benefit as a bacterial medicine expressing genes with therapeutic or prophylactic potential within the human nasopharynx.

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Identifiers

ORCID for Jay Laver: orcid.org/0000-0003-3314-5989

ORCID for Robert Read: orcid.org/0000-0002-4297-6728

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