<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02249598</url>
  </required_header>
  <id_info>
    <org_study_id>STH16097</org_study_id>
    <nct_id>NCT02249598</nct_id>
  </id_info>
  <brief_title>Competitive Carriage of Neisseria Spp(Lactamica 2)</brief_title>
  <acronym>Lactamica 2</acronym>
  <official_title>Competitive Carriage of Neisseria Spp.; Discovering New Methods of Inhibiting Carriage of Neisseria Meningitidis (Lactamica 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the future it is likely that we will replace the current schedule of injected vaccines&#xD;
      with interventions that interrupt transmission of infections in more subtle ways. The agent&#xD;
      that causes meningococcal disease (Neisseria meningitidis) colonises the nasopharynx of&#xD;
      individuals. In most people, the bacterium is harmless and survives for months in the&#xD;
      nasopharynx, however in a minority of people the bacteria can cause invasive disease.&#xD;
&#xD;
      Simply reducing colonisation amongst target groups may protect them, and the rest of the&#xD;
      population as well. In a previous study we investigated cross protective antibodies, and&#xD;
      found incidentally that inoculating adult volunteers with Neisseria lactamica, a harmless&#xD;
      'cousin' of N. meningitidis, possibly prevents N. meningitidis carriage. If true this could&#xD;
      lead to novel mechanisms of reducing colonisation in targeted groups, possibly in the form of&#xD;
      a nasal medication. The proposed study large experimental challenge study funded by&#xD;
      Meningitis UK that will aim to establish if N. lactamica does or does not inhibit&#xD;
      colonisation by N. meningitidis. We will also determine whether N. lactamica displaces&#xD;
      existing N. meningitidis carriage, and whether there are individuals who are innately&#xD;
      resistant to any Neisseria carriage. The study will recruit 300 volunteers between the ages&#xD;
      of 1830yrs from the two universities in Sheffield. It will involve placing droplets of&#xD;
      N.lactamica bacteria into the nose of half our group of volunteers, and a harmless water like&#xD;
      solution into the nose of the other half of volunteers. We will carry out nose swabs at&#xD;
      intervals over a six month period to establish if the pattern of N.meningitidis carriage is&#xD;
      effected by N.lactamica colonisation. If the findings are positive we will perform future&#xD;
      mechanistic investigations. A62.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>number of positive results presenting between day 0 (baseline) until study completion (28 weeks)</time_frame>
    <description>culture of throat swabs at 2 weeks, 4 weeks, 8 weeks, 16 weeks, 26 weeks and 28 weeks.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Neisseria Lactamica</condition>
  <arm_group>
    <arm_group_label>Univeristy of Sheffield</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>lactamica</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hallam University</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Phosphate Buffered Saline (PBS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>lactamica</intervention_name>
    <arm_group_label>Univeristy of Sheffield</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Hallam University</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently healthy&#xD;
&#xD;
          -  Students and university employees from either Sheffield Hallam University or the&#xD;
             University of Sheffield between the ages of 18 and 25yrs.&#xD;
&#xD;
          -  Fully conversant in the English language&#xD;
&#xD;
          -  Able to attend the full protocol timetable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are Immunocompromised due to a medical condition&#xD;
&#xD;
          -  Individuals taking immune modifying medications (not including inhaled steroids)&#xD;
&#xD;
          -  Individuals in close contact with immunocompromised people including medical students&#xD;
             with full time clinical attachments.&#xD;
&#xD;
          -  Individuals who have an current infection&#xD;
&#xD;
          -  Current Smokers&#xD;
&#xD;
          -  People with an allergy to yeast extract.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Read</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorskshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 22, 2014</last_update_submitted>
  <last_update_submitted_qc>September 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02249598
org study id: STH16097
nct id: NCT02249598
lead sponsor: 
has dmc: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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)
description: culture of throat swabs at 2 weeks, 4 weeks, 8 weeks, 16 weeks, 26 weeks and 28 weeks.
arm group label: Univeristy of Sheffield
arm group type: Experimental
description: lactamica
arm group label: Hallam University
arm group type: Placebo Comparator
description: Phosphate Buffered Saline (PBS)
intervention type: Biological
intervention name: lactamica
arm group label: Univeristy of Sheffield
intervention type: Biological
intervention name: Placebo
arm group label: Hallam University
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Read
role: Principal Investigator
affiliation: Sheffield NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor