NCT02249598: Lactamica 2

Competitive Carriage of Neisseria Spp.; Discovering New Methods of Inhibiting Carriage of Neisseria Meningitidis (Lactamica 2)

Completed NA Last updated 22 September 2014

What this trial tests

NA trial testing lactamica in Neisseria Lactamica in 300 participants. Completed.

Timeline

1 July 2013

Primary endpoint
1 November 2013

Quick facts

Lead sponsor	Sheffield Teaching Hospitals NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	1 July 2013
Primary completion	1 November 2013
Sites	1 location across United Kingdom

Drugs / interventions tested

• lactamica — full drug profile →
• Placebo

Conditions studied

• Neisseria Lactamica — all drugs for Neisseria Lactamica →

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Who can join

Adults 18 to 60, any sex, with Neisseria Lactamica. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The number of participants found to have carriage of the bacterium Neisseria meningitidis at 6 sampling points (culture of throat swaps) following innoculation as baseline of subjects with the bacterium Neisseria lactamica
  Time frame: number of positive results presenting between day 0 (baseline) until study completion (28 weeks)
  culture of throat swabs at 2 weeks, 4 weeks, 8 weeks, 16 weeks, 26 weeks and 28 weeks.

Sponsor's own description

In the future it is likely that we will replace the current schedule of injected vaccines with interventions that interrupt transmission of infections in more subtle ways. The agent that causes meningococcal disease (Neisseria meningitidis) colonises the nasopharynx of individuals. In most people, the bacterium is harmless and survives for months in the nasopharynx, however in a minority of people the bacteria can cause invasive disease.

Simply reducing colonisation amongst target groups may protect them, and the rest of the population as well. In a previous study we investigated cross protective antibodies, and found incidentally that inoculating adult volunteers with Neisseria lactamica, a harmless 'cousin' of N. meningitidis, possibly prevents N. meningitidis carriage. If true this could lead to novel mechanisms of reducing colonisation in targeted groups, possibly in the form of a nasal medication. The proposed study large experimental challenge study funded by Meningitis UK that will aim to establish if N. lactamica does or does not inhibit colonisation by N. meningitidis. We will also determine whether N. lactamica displaces existing N. meningitidis carriage, and whether there are individuals who are innately resistant to any Neisseria carriage. The study will recruit 300 volunteers between the ages of 1830yrs from the two universities in Sheffield. It will involve placing droplets of N.lactamica bacteria into the nose of half our group of volunteers, and a harmless water like solution into the nose of the other half of volunteers. We will carry out nose swabs at intervals over a six month period to establish if the pattern of N.meningitidis carriage is effected by N.lactamica colonisation. If the findings are positive we will perform future mechanistic investigations. A62.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nasal Inoculation of the Commensal Neisseria lactamica Inhibits Carriage of Neisseria meningitidis by Young Adults: A Controlled Human Infection Study.
   Deasy AM, Guccione E, Dale AP, Andrews N, et al · · 2015 · cited 91× · PMID 25814628 · DOI 10.1093/cid/civ098
2. Microevolution of Neisseria lactamica during nasopharyngeal colonisation induced by controlled human infection.
   Pandey A, Cleary DW, Laver JR, Gorringe A, et al · · 2018 · cited 24× · PMID 30420631 · DOI 10.1038/s41467-018-07235-5