Neisseria Lactamica Clinical Trial
— Lactamica 2Official title:
Competitive Carriage of Neisseria Spp.; Discovering New Methods of Inhibiting Carriage of Neisseria Meningitidis (Lactamica 2)
| NCT number | NCT02249598 |
| Other study ID # | STH16097 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | August 12, 2014 |
| Last updated | September 22, 2014 |
| Start date | July 2013 |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Sheffield Teaching Hospitals | Sheffield | South Yorskshire |
| Lead Sponsor | Collaborator |
|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |