Lyophilised Neisseria lactamica nasal challenge study
Research type
Research Study
Full title
A human controlled infection study to assess safety, colonisation and immunogenicity following nasal inoculation with reconstituted lyophilised wild type Neisseria lactamica: Lactamica 5
IRAS ID
235091
Contact name
Robert C Read
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Neisseria lactamica are harmless bacteria which frequently live in the noses of infants without causing disease (colonisation). In previous studies we have shown that if you put N. lactamica in the nose of healthy adults (inoculate them), 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). We have previously used a wild-type strain of N. lactamica safely in experimental challenge of over 350 human volunteers. These previous challenges have been conducted using frozen stocks of Nlac but this is relatively unsatisfactory because of instability of frozen stocks.
In this pilot research we will develop and validate a modification of the methodology previously used in our human challenge experiments, using reconstituted, previously lyophilised N. lactamica (lyoNlac). This will greatly simplify the experimental method and make future planned studies in low resource settings more practical. However, we do not know whether lyoNlac can be inoculated directly into volunteers and induce successful colonisation.
In summary this is a pilot study of the safety, efficacy and immunogenicity of the intranasal inoculation of healthy human volunteers with lyoNlac. This study will determine the efficacy of lyoNlac as an agent for inducing nasopharyngeal colonisation with this organism, which is an important methodological development for ease of administration of Nlac in experimental human challenge studies. We will aim to determine the dose of inoculum required to induce colonisation in 80% of volunteers (the Standard Inoculum or SI). This SI will be used in future studies aiming to optimise duration of colonisation and immunogenicity induced by lyoNlac.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0420
Date of REC Opinion
28 Sep 2018
REC opinion
Further Information Favourable Opinion