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, 2019 05 01.
Article
em En
| MEDLINE
| ID: mdl-31048443
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 ANDANALYSIS:
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. TRIAL REGISTRATION NUMBER NCT03630250; Pre-results.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
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Adesinas Bacterianas
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Vacinas Meningocócicas
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Neisseria lactamica
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Microrganismos Geneticamente Modificados
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Antígenos
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Neisseria meningitidis
Tipo de estudo:
Guideline
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Adolescent
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Adult
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Humans
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Middle aged
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Reino Unido