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A Study Assessing Colonisation & Immunogenicity After Nasal Inoculation With N. Lactamica and Eradication on Day 4 or 14

NCT03549325 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-02-12

Study results available
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Summary

This study is part of a project that aims to develop a vaccine with N. lactamica that prevents meningitis. The investigators have previously given nose drops containing N. lactamica to over 340 volunteers, and shown that many of the volunteers (35-60%) become colonised without causing any illness or disease. In the future the investigators would like to modify N. lactamica so that it can carry vaccine molecules into the nose of children. To do this the investigators need to know more about the immune response generated against N. lactamica. Previously the investigators have shown that inoculation resulted in an immune (antibody) response in volunteers who were colonised. Taking an antibiotic called ciprofloxacin will treat N.lactamica in the nose and throat of the volunteers. The investigators need to know if the immune response to N. lactamica is the same when colonised volunteers are treated with the antibiotic after 4 days, is the same if the investigators treat volunteers after 14 days of carriage. This information will inform future studies.

Conditions

  • Meningitis, Meningococcal

Interventions

BIOLOGICAL

Neisseria lactamica

Colonisation by bacteria is an immunising event; we proved this in humans by inoculating university students intranasally with the harmless commensal N. lactamica and we observed both specific systemic and mucosal antibody responses by 4 weeks. Experimental challenge with defined bacteria could tease out the Th17-mediated response mechanisms, which include waning of immunity over time, the induction of an incorrectly polarised T cell response, lack of cross-reactivity between strains or active immune evasion mechanisms employed by bacteria to subvert host immune effector mechanisms.

Sponsors & Collaborators

  • University of Southampton

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Robert Read · University of Southampton

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2021-12-02
Completion
2021-12-02

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549325 on ClinicalTrials.gov