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Protocol for a controlled human infection with genetically modified Neisseria lactamica expressing the meningococcal vaccine antigen NadA: a potent new technique for experimental medicine

Protocol for a controlled human infection with genetically modified Neisseria lactamica expressing the meningococcal vaccine antigen NadA: a potent new technique for experimental medicine
Protocol for a controlled human infection with genetically modified Neisseria lactamica expressing the meningococcal vaccine antigen NadA: a potent new technique for experimental medicine

Introduction :Neisseria lactamica is a commensal organism found in the human nasopharynx and is closely related to the pathogen N. meningitidis (meningococcus). Carriage of N. lactamica is associated with reduced meningococcal carriage and disease. We summarise an ethically approved protocol for an experimental human challenge study using a genetically modified strain of N. lactamica that expresses the meningococcal antigen NadA. We aim to develop a model to study the role of specific bacterial antigens in nasopharyngeal carriage and immunity, to evaluate vaccines for their efficacy in preventing colonisation and to provide a proof of principle for the development of bacterial medicines.

Methods and analysis: healthy adult volunteers aged 18–45 years will receive an intranasal inoculation of either the NadA containing strain of N. lactamica or a genetically modified, but wild-type equivalent control strain. These challenge volunteers will be admitted for 4.5 days observation following inoculation and will then be discharged with strict infection control rules. Bedroom contacts of the challenge volunteers will also be enrolled as contact volunteers. Safety, colonisation, shedding, transmission and immunogenicity will be assessed over 90 days after which carriage will be terminated with antibiotic eradication therapy.

Ethics and dissemination: this study has been approved by the Department for Environment, Food and Rural Affairs and South Central Oxford A Research Ethics Committee (reference: 18/SC/0133). Findings will be published in peer-reviewed open-access journals as soon as possible.

2044-6055
e026544
Gbesemete, Diane
2543380e-16b0-42b4-9d0f-88421ac33106
Laver, Jay Robert
b2996398-2ccf-40f0-92b8-f338f3de796b
de Graaf, Hans
447e78ed-346f-45bb-9238-fce2118d5559
Ibrahim, Muktar
15bab4d1-f800-4d51-9ac6-d7999bd2a5d2
Vaughan, Andrew
bfb2ceab-a592-457e-89f9-00fcd1dddbdb
Faust, Saul
f97df780-9f9b-418e-b349-7adf63e150c1
Gorringe, Andrew
503cb828-4e75-44e9-a8af-61f814e02bc6
Read, Robert Charles
b5caca7b-0063-438a-b703-7ecbb6fc2b51
Gbesemete, Diane
2543380e-16b0-42b4-9d0f-88421ac33106
Laver, Jay Robert
b2996398-2ccf-40f0-92b8-f338f3de796b
de Graaf, Hans
447e78ed-346f-45bb-9238-fce2118d5559
Ibrahim, Muktar
15bab4d1-f800-4d51-9ac6-d7999bd2a5d2
Vaughan, Andrew
bfb2ceab-a592-457e-89f9-00fcd1dddbdb
Faust, Saul
f97df780-9f9b-418e-b349-7adf63e150c1
Gorringe, Andrew
503cb828-4e75-44e9-a8af-61f814e02bc6
Read, Robert Charles
b5caca7b-0063-438a-b703-7ecbb6fc2b51

Gbesemete, Diane, Laver, Jay Robert, de Graaf, Hans, Ibrahim, Muktar, Vaughan, Andrew, Faust, Saul, Gorringe, Andrew and Read, Robert Charles (2019) Protocol for a controlled human infection with genetically modified Neisseria lactamica expressing the meningococcal vaccine antigen NadA: a potent new technique for experimental medicine. BMJ Open, 9 (4), e026544. (doi:10.1136/bmjopen-2018-026544).

Record type: Article

Abstract

Introduction :Neisseria lactamica is a commensal organism found in the human nasopharynx and is closely related to the pathogen N. meningitidis (meningococcus). Carriage of N. lactamica is associated with reduced meningococcal carriage and disease. We summarise an ethically approved protocol for an experimental human challenge study using a genetically modified strain of N. lactamica that expresses the meningococcal antigen NadA. We aim to develop a model to study the role of specific bacterial antigens in nasopharyngeal carriage and immunity, to evaluate vaccines for their efficacy in preventing colonisation and to provide a proof of principle for the development of bacterial medicines.

Methods and analysis: healthy adult volunteers aged 18–45 years will receive an intranasal inoculation of either the NadA containing strain of N. lactamica or a genetically modified, but wild-type equivalent control strain. These challenge volunteers will be admitted for 4.5 days observation following inoculation and will then be discharged with strict infection control rules. Bedroom contacts of the challenge volunteers will also be enrolled as contact volunteers. Safety, colonisation, shedding, transmission and immunogenicity will be assessed over 90 days after which carriage will be terminated with antibiotic eradication therapy.

Ethics and dissemination: this study has been approved by the Department for Environment, Food and Rural Affairs and South Central Oxford A Research Ethics Committee (reference: 18/SC/0133). Findings will be published in peer-reviewed open-access journals as soon as possible.

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Accepted/In Press date: 6 March 2019
Published date: 1 May 2019

Identifiers

Local EPrints ID: 430983
URI: http://eprints.soton.ac.uk/id/eprint/430983
ISSN: 2044-6055
PURE UUID: 652bbf42-8cfd-41c0-9aec-5efebd9cb7b4
ORCID for Jay Robert Laver: ORCID iD orcid.org/0000-0003-3314-5989
ORCID for Andrew Vaughan: ORCID iD orcid.org/0000-0001-6076-3649
ORCID for Saul Faust: ORCID iD orcid.org/0000-0003-3410-7642
ORCID for Robert Charles Read: ORCID iD orcid.org/0000-0002-4297-6728

Catalogue record

Date deposited: 21 May 2019 16:30
Last modified: 16 Mar 2024 04:13

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Contributors

Author: Diane Gbesemete
Author: Hans de Graaf
Author: Muktar Ibrahim
Author: Andrew Vaughan ORCID iD
Author: Saul Faust ORCID iD
Author: Andrew Gorringe

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