<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/NCT02991417</url>
  </required_header>
  <id_info>
    <org_study_id>CDVAX</org_study_id>
    <nct_id>NCT02991417</nct_id>
  </id_info>
  <brief_title>Oral Vaccination Against Clostridium Difficile Infection</brief_title>
  <acronym>CDVAX</acronym>
  <official_title>Safety and Immunogenicity Study of a Clostridium Difficile Vaccine in Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Simon M. Cutting</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal Holloway University</source>
  <brief_summary>
    <textblock>
      This clinical study is conducted to assess the safety and immunogenicity of a Clostridium&#xD;
      difficile vaccine (CDVAX) in healthy adult volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 8, 2017</completion_date>
  <primary_completion_date type="Actual">March 14, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of adverse events</measure>
    <time_frame>First treatment up to end of treatment + 28 days (70 days after treatment start)</time_frame>
    <description>Measured by routine physical and laboratory evaluations, adverse event monitoring, ECG and neurological examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of specific mucosal and systemic immunity</measure>
    <time_frame>First treatment up to end of treatment + 14 days (56 days after starting study drug)</time_frame>
    <description>Measured by specific secretory IgA, serum IgA and serum IgG</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>CDVAX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CDVAX</intervention_name>
    <arm_group_label>CDVAX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent&#xD;
&#xD;
          2. Male&#xD;
&#xD;
          3. Age: 18-50 years (limits included)&#xD;
&#xD;
          4. Body mass index within 18.5 and 29.9 kg/m²&#xD;
&#xD;
          5. Ability to read and comprehend study information&#xD;
&#xD;
          6. Non-smokers or light smokers (&lt;4 cigarettes per day)&#xD;
&#xD;
          7. In good physical and mental health as determined by the following:&#xD;
&#xD;
               1. Complete medical history&#xD;
&#xD;
               2. Complete physical and neurological examination&#xD;
&#xD;
               3. Vital signs including blood pressure, heart rate, respiratory rate, and&#xD;
                  temperature&#xD;
&#xD;
               4. Standard 12-lead ECG&#xD;
&#xD;
               5. Clinical laboratory (biochemistry, haematology and urinalysis) tests. Blood and&#xD;
                  urine samples may be drawn up to 3 weeks prior to the baseline visit of the study&#xD;
                  provided all data are available and evaluated prior to administration of study&#xD;
                  drug. Values of laboratory results outside normal reference ranges may be&#xD;
                  acceptable if the investigator considers that they do not compromise the safety&#xD;
                  of the subjects or the conduct of the study.&#xD;
&#xD;
               6. Vital signs, clinical laboratory measurements, and ECG measurements may be&#xD;
                  repeated at the discretion of the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of C. difficile infection&#xD;
&#xD;
          2. Anti-C. difficile (Toxin A) immunoreactivity, suggesting previous C. difficile&#xD;
             exposure&#xD;
&#xD;
          3. Diarrhoea, active or inactive inflammatory bowel disease, irritable colon syndrome,&#xD;
             chronic abdominal pain or other chronic diarrhoea&#xD;
&#xD;
          4. History of malignancy within 5 years&#xD;
&#xD;
          5. History of anaphylaxis, asthma or severe vaccine or allergic drug reaction&#xD;
&#xD;
          6. Known or suspected history of immunodeficiency, active or inactive immune-mediated or&#xD;
             inflammatory disease&#xD;
&#xD;
          7. Receipt of antibiotic therapy, immunosuppressants, or corticosteroids within the&#xD;
             previous 30 days&#xD;
&#xD;
          8. Vaccination within the previous 30 days (except for influenza vaccination)&#xD;
&#xD;
          9. Blood or organ donation within the previous 60 days&#xD;
&#xD;
         10. Evidence of clinically significant psychiatric, gastrointestinal, neurologic,&#xD;
             neuromuscular, hepatic, pulmonary, cardiovascular, or renal disease (as judged by the&#xD;
             investigator)&#xD;
&#xD;
         11. Use of prescription medication or regular use of over-the-counter medicines or herbal&#xD;
             or dietary supplements. Acetaminophen/paracetamol may be used intermittently as needed&#xD;
             for pain&#xD;
&#xD;
         12. History or current evidence of abuse of any drug substance, licit or illicit,&#xD;
             including alcohol; a positive urine screen for drugs of abuse&#xD;
&#xD;
         13. Positive hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg) or positive&#xD;
             human immunodeficiency virus (HIV)-1/2 antibodies&#xD;
&#xD;
         14. Participation in any other investigational drug or device study within 60 days prior&#xD;
             to the first study drug administration&#xD;
&#xD;
         15. Relatives of, or staff directly reporting to the principal investigator&#xD;
&#xD;
         16. Vulnerable subjects&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Royal Holloway University</investigator_affiliation>
    <investigator_full_name>Simon M. Cutting</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Clostridium Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT02991417
org study id: CDVAX
nct id: NCT02991417
lead sponsor: 
This clinical study is conducted to assess the safety and immunogenicity of a Clostridium
      difficile vaccine (CDVAX) in healthy adult volunteers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence and severity of adverse events
time frame: First treatment up to end of treatment + 28 days (70 days after treatment start)
description: Measured by routine physical and laboratory evaluations, adverse event monitoring, ECG and neurological examination
measure: Evaluation of specific mucosal and systemic immunity
time frame: First treatment up to end of treatment + 14 days (56 days after starting study drug)
description: Measured by specific secretory IgA, serum IgA and serum IgG
arm group label: CDVAX
arm group type: Experimental
intervention type: Biological
intervention name: CDVAX
arm group label: CDVAX
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Royal Holloway University
investigator full name: Simon M. Cutting
investigator title: Professor
mesh term: Infections
mesh term: Clostridium Infections