Competitive Carriage of Neisseria Spp(Lactamica 2)

NCT02249598 | Completed

• 1 other identifier: STH16097
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neisseria Lactamica

Outcome Measures

Primary Outcomes (1)

• 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

  culture of throat swabs at 2 weeks, 4 weeks, 8 weeks, 16 weeks, 26 weeks and 28 weeks.

  number of positive results presenting between day 0 (baseline) until study completion (28 weeks)

Study Arms (2)

Univeristy of Sheffield

EXPERIMENTAL

lactamica

Biological: lactamica

Hallam University

PLACEBO COMPARATOR

Phosphate Buffered Saline (PBS)

Biological: Placebo

Interventions

lactamica BIOLOGICAL

Univeristy of Sheffield

Placebo BIOLOGICAL

Hallam University

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Currently healthy
• Students and university employees from either Sheffield Hallam University or the University of Sheffield between the ages of 18 and 25yrs.
• Fully conversant in the English language
• Able to attend the full protocol timetable

You may not qualify if:

• Individuals who are Immunocompromised due to a medical condition
• Individuals taking immune modifying medications (not including inhaled steroids)
• Individuals in close contact with immunocompromised people including medical students with full time clinical attachments.
• Individuals who have an current infection
• Current Smokers
• People with an allergy to yeast extract.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals

Sheffield, South Yorskshire, S10 2JF, United Kingdom

Location

Related Publications (1)

• Deasy AM, Guccione E, Dale AP, Andrews N, Evans CM, Bennett JS, Bratcher HB, Maiden MC, Gorringe AR, Read RC. Nasal Inoculation of the Commensal Neisseria lactamica Inhibits Carriage of Neisseria meningitidis by Young Adults: A Controlled Human Infection Study. Clin Infect Dis. 2015 May 15;60(10):1512-20. doi: 10.1093/cid/civ098. Epub 2015 Mar 25.

  PMID: 25814628 DERIVED

Study Officials

• Robert Read

  Sheffield NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: September 25, 2014
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

GB (1)