TerminatedNot Applicable

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

Stopped: Recruitment was paused in March 2020 due to the COVID pandemic. An interim data analysis was conducted in 2021 which confirmed that sufficient data had been collected to meet the primary objective, therefore the study was terminated.

United Kingdom21 participantsStarted 2017-03-13

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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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 …

What they're measuring

Measure the Antibodies, by Serological Antibody Titration, of Short Term Colonisation and Longer Colonisation

Timeframe: Up to 42 Days

Trial details

NCT IDNCT03549325

SponsorUniversity Hospital Southampton NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-02

Results submitted2026-01-21