Nose drops with friendly bacteria could pave way for meningitis vaccine
NCT ID NCT03549325
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study gave healthy adults nose drops containing a harmless bacteria (N. lactamica) to see how the body's immune system responds. The goal is to learn if the immune response is the same whether the bacteria is cleared after 4 days or 14 days. This information will help design a future vaccine to prevent meningitis.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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21 people
The number who actually took part.
- Started
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Mar 2017
- Finished
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Dec 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy adults aged 18 to 45 years inclusive on the day of enrolment * Fully conversant in the English language * Able and willing (in the investigator's opinion) to comply with all study requirements * Written informed consent to participate in the trial * Willingness to take an antibiotic regimen after inoculation according to the study protocol * For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and inoculation Exclusion Criteria: * Current active smokers * N. lactamica or N. meningitidis detected on throat swab or nasal wash taken before the challenge * Individuals who have a current infection at the time of inoculation * Individuals who have been involved in other clinical trials involving receipt of an investigational product over the last 12 weeks or if there is planned use of an investigational product during the study period * Individuals who have previously been involved in clinical trials investigating meningococcal vaccines or experimental challenge with N. lactamica * Use of systemic antibiotics within the period 30 days prior to the challenge * Any confirmed or suspected immunosuppressive or immune-deficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed) * Use of immunoglobulins or blood products within 3 months prior to enrolment. * History of allergic disease or reactions likely to be exacerbated by any component of the inoculum * Contraindications to the use of ciprofloxacin, specifically a history of epilepsy, prolonged QT interval, hypersensitivity to quinolones or a history of tendon disorders related to quinolone use * Any clinically significant abnormal finding on clinical examination * Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data, for example recent surgery to the nasopharynx * Occupational, household or intimate contact with immunosuppressed persons * Pregnancy or lactation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Southampton NIHR Clinical Research Facility
Southampton, Hampshire, SO166YD, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.