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.
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
1 May 2019
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), .
(doi:10.1136/bmjopen-2018-026544).
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.
Text
Protocol for a controlled human infection
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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
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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
Author:
Andrew Gorringe
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