Neisseria lactamica with NadA - A human challenge study
Research type
Research Study
Full title
Experimental challenge of the human nasopharynx with recombinant Neisseria lactamica expressing the meningococcal type V autotransporter protein Neisseria Adhesin A (NadA) - Lactamica 4
IRAS ID
235090
Contact name
Robert C Read
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
3 years, 0 months, 31 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. \nIn this study we will be inoculating healthy volunteers with a genetically modified strain of N. lactamica. This strain has been modified to express the Neisseria meningitidis antigen NadA, a vaccine component of the Bexsero childhood vaccine. A control group will receive a control strain of N. lactamica which has undergone the same modification process but without the addition of the gene coding for NadA. These “challenge volunteers” (inoculated with either intervention or control strains) will be admitted to the NIHR Clinical Research Facility in Southampton and monitored for 4.5 days. Following this they will be discharged and followed up for 3 months. Challenge volunteers will be assessed for safety, colonisation, shedding and immune response.\n\nA further group of “contact volunteers” will be recruited. These will be bedroom contacts (i.e. spouses or partners) of the challenge volunteers. They will be monitored for onward transmission of the inoculated strains, and for safety.\n\nAll volunteers will be given eradication antibiotic therapy to clear colonisation at day 90 of the study, or sooner if required due to increased shedding, transmission or safety concerns. Contact volunteers will be given eradication therapy if they are found to be colonised at any point in the study. \n\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0133
Date of REC Opinion
20 Apr 2018
REC opinion
Favourable Opinion