Wild type N. lactamica challenge and eradication pilot study
Research type
Research Study
Full title
A human controlled infection study to assess colonisation and immunogenicity following nasal inoculation with Neisseria lactamica with eradication on Day 4 or 14
IRAS ID
207453
Contact name
Robert C. Read
Contact email
Sponsor organisation
Southampton University Hospital
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Neisseria lactamica are bacteria frequently found in the noses of infants which don't cause disease and can be considered `friendly bacteria`. In a previous study we showed that if you put N. lactamica in the nose of healthy adults, this causes no harm to the volunteers, the bacteria can colonise their noses and cause an immune response, measured two weeks after giving it. Furthermore the bacteria seem to prevent the colonisation of the nose by potentially harmful bacteria (ones that can cause meningitis). In order to design further studies looking at this we need to shorten the period of experimental colonisation, so in this study we will find out if a short period of colonisation (4 days) results in the same level of immune response as if a volunteers has a longer period of colonisation (14 days). This study will also test how effective antibiotic treatment is in eradicating colonisation. To accomplish this, healthy adult volunteers will receive a nasal inoculation of N. lactamica and antibiotic therapy will be given on day 4 or 14. A wild-type strain of N. lactamica will be used for this study, selected because we have previously used it safely in experimental challenge of over 340 human volunteers.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0425
Date of REC Opinion
25 Oct 2016
REC opinion
Further Information Favourable Opinion