<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/NCT03303976</url>
  </required_header>
  <id_info>
    <org_study_id>Pneumo1</org_study_id>
    <nct_id>NCT03303976</nct_id>
  </id_info>
  <brief_title>Phase I to Test a New Pneumococcal Vaccine</brief_title>
  <official_title>Safety and Immunogenicity of a Candidate Bioconjugate Vaccine Against Streptococcus Pneumoniae When Administered to Adult and Elderly Healthy Subjects. A Phase I Randomized Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LimmaTech Biologics AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LimmaTech Biologics AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To obtain first-in-human data on a new candidate vaccine against Streptococcus pneumoniae in&#xD;
      healthy adult and elderly volunteers.&#xD;
&#xD;
      The study aims to assess the safety and immunogenicity of a bioconjugate investigational&#xD;
      vaccine compared to the control group (Pneumovax23).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to assess the safety and immunogenicity of a new bioconjugate investigational&#xD;
      vaccine compared to the control group (Pneumovax23) in a randomised, staggered, 2-steps&#xD;
      controlled trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">September 12, 2018</completion_date>
  <primary_completion_date type="Actual">September 12, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>until one month after injection</time_frame>
    <description>Safety and tolerability of the candidate vaccine as determined by occurrence, severity, relationship, of solicited and unsolicited advers events (AEs) and serious adverse events (SAEs) after injection of the candidate vaccine compared to the control group throughout the study until one month after injection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical laboratory abnormality measure</measure>
    <time_frame>change from baseline one week after injection and one month after injection</time_frame>
    <description>Safety of the candidate vaccine by measuring changes in haematological and biochemical safety parameters before injection (baseline) and after vaccine administration, in terms of absolute changes and between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess immunogenicity of the candidate vaccine</measure>
    <time_frame>one month and six months after injection</time_frame>
    <description>Evaluation of antigen-specific antibodies levels and functionality at each time point for all groups in terms of change from baseline</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Pneumococcal Pneumonia</condition>
  <condition>Pneumonia, Bacterial</condition>
  <arm_group>
    <arm_group_label>Pneumo1-low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm A: intramuscular injection monovalent bioconjugate pneumococcal vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pneumo1-mid dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm B: intramuscular injection monovalent bioconjugate pneumococcal vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pneumo1-target dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm C: intramuscular injection monovalent bioconjugate pneumococcal vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pneumovax23</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm D: intramuscular injection multivalent plain polysaccharide vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bioconjugate pneumococcal vaccine</intervention_name>
    <description>Bioconjuagte vaccine against bacterial pneumococcal infection</description>
    <arm_group_label>Pneumo1-low dose</arm_group_label>
    <arm_group_label>Pneumo1-mid dose</arm_group_label>
    <arm_group_label>Pneumo1-target dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Multivalent plain polysaccharide vaccine</intervention_name>
    <description>Multivalent plain polysaccharide vaccine against bacterial pneumococcal infection</description>
    <arm_group_label>Pneumovax23</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between 60 and 70 (inclusive) years of age at the time of vaccination.&#xD;
&#xD;
          -  Subject who is willing and able to comply with the requirements of the protocol (e.g.&#xD;
             completion of the diary cards, return for follow-up visits).&#xD;
&#xD;
          -  Signed informed consent obtained from the subject.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Health condition that, in the opinion of the investigator, may interfere with optimal&#xD;
             participation in the study or place the volunteer at increased risk of adverse events&#xD;
             (AEs). Study clinicians, in consultation with the principal investigator, will use&#xD;
             clinical judgment on a case-by-case basis to assess safety risks under this criterion.&#xD;
             The PI will consult with the medical monitor as appropriate. • Clinically significant&#xD;
             abnormalities on physical examination.&#xD;
&#xD;
          -  Clinically significant abnormalities on laboratory screening.&#xD;
&#xD;
          -  Acute or chronic, clinically significant cardiovascular, pulmonary, hepatic or renal&#xD;
             abnormality, diseases and/or insufficiency as determined by physical examination or&#xD;
             laboratory tests, in particular: unstable current or history of coronary artery&#xD;
             disease or cardiac insufficiency, uncontrolled hypertension, clinically significant&#xD;
             history of myocardial infarction, atrial fibrillation, uncontrolled or clinically&#xD;
             significant type 2 diabetes, current or history of rheumatoid arthritis or temporal&#xD;
             arteritis, current acute or chronic active pulmonary diseases.&#xD;
&#xD;
          -  Planned administration of a vaccine not foreseen by the study protocol within 4 weeks&#xD;
             before and after the vaccination.&#xD;
&#xD;
          -  Previous vaccination with any licensed or investigational pneumococcal vaccine or&#xD;
             planned administration of a pneumococcal vaccination not foreseen by the study&#xD;
             protocol and during the study period, as reported by subject.&#xD;
&#xD;
          -  History of radiologically documented pneumonia or invasive pneumococcal disease (IPD)&#xD;
             within 3 years previous to study start, as reported by subject.&#xD;
&#xD;
          -  Known hypersensitivity to any components of the pneumococcal conjugate vaccine.&#xD;
&#xD;
          -  Previous vaccination with any pseudomonas investigational vaccine as reported by the&#xD;
             subject.&#xD;
&#xD;
          -  Known or suspected impairment of immunological function, documented Human&#xD;
             Immunodeficiency Virus (HIV) infection, asplenia, or history of autoimmune disease.&#xD;
&#xD;
          -  History of regular use (&gt;2 weeks) in the last 6 months of immunosuppressive drugs&#xD;
             including systemic corticosteroids (e.g. corticosteroids ≥0.5 mg/kg BW/day, excluding&#xD;
             inhaled and topical steroid).&#xD;
&#xD;
          -  Has a coagulation disorder contraindicating intramuscular vaccination..&#xD;
&#xD;
          -  Received or receiving immunosuppressive therapy, including chemotherapeutic agents&#xD;
             used to treat cancer or other conditions, and treatments associated with organ or bone&#xD;
             marrow transplantation or autoimmune disease.&#xD;
&#xD;
          -  Received a blood transfusion or previous treatment with blood products, including&#xD;
             immunoglobulins within the 3 months preceding the injection, or is scheduled to&#xD;
             receive them within 30 days after vaccination.&#xD;
&#xD;
          -  Use of any investigational or non-registered product (drug or vaccine) other than the&#xD;
             study vaccine(s) within 3 months preceding the administration of study vaccine, or&#xD;
             planned use during the study period.&#xD;
&#xD;
          -  BMI (Body Mass Index) &lt;19 or ≥35.&#xD;
&#xD;
          -  Positive blood test for HBsAg, hepatitis C virus (HCV), HIV-1/2.&#xD;
&#xD;
          -  History of allergy to any vaccine.&#xD;
&#xD;
          -  Use of any antibiotic therapy within 1 week preceding injection.&#xD;
&#xD;
          -  Subjects with an elective surgical intervention, planned during the study period.&#xD;
&#xD;
          -  History of chronic alcohol consumption and/or drug abuse.&#xD;
&#xD;
          -  Blood donation of at least 500 mL blood draw within 3 months preceding injection or&#xD;
             planned during the study period as reported by subject.&#xD;
&#xD;
          -  Pregnancy or intention to become pregnant as reported by subject.&#xD;
&#xD;
          -  Female subjects who are not postmenopausal for at least 2 years.&#xD;
&#xD;
          -  Man subjects with a female partner in reproductive age refusing to use contraception&#xD;
             methods.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Leidig, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CRS Mönchengladbach</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRS</name>
      <address>
        <city>Mönchengladbach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pneumococcal vaccine</keyword>
  <keyword>bioconjugate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Bacterial</mesh_term>
    <mesh_term>Pneumonia, Pneumococcal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03303976
org study id: Pneumo1
nct id: NCT03303976
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To obtain first-in-human data on a new candidate vaccine against Streptococcus pneumoniae in
      healthy adult and elderly volunteers.

      The study aims to assess the safety and immunogenicity of a bioconjugate investigational
      vaccine compared to the control group (Pneumovax23).
The study aims to assess the safety and immunogenicity of a new bioconjugate investigational
      vaccine compared to the control group (Pneumovax23) in a randomised, staggered, 2-steps
      controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Incidence of adverse events
time frame: until one month after injection
description: Safety and tolerability of the candidate vaccine as determined by occurrence, severity, relationship, of solicited and unsolicited advers events (AEs) and serious adverse events (SAEs) after injection of the candidate vaccine compared to the control group throughout the study until one month after injection.
measure: Clinical laboratory abnormality measure
time frame: change from baseline one week after injection and one month after injection
description: Safety of the candidate vaccine by measuring changes in haematological and biochemical safety parameters before injection (baseline) and after vaccine administration, in terms of absolute changes and between groups.
measure: Assess immunogenicity of the candidate vaccine
time frame: one month and six months after injection
description: Evaluation of antigen-specific antibodies levels and functionality at each time point for all groups in terms of change from baseline
arm group label: Pneumo1-low dose
arm group type: Experimental
description: Arm A: intramuscular injection monovalent bioconjugate pneumococcal vaccine
arm group label: Pneumo1-mid dose
arm group type: Experimental
description: Arm B: intramuscular injection monovalent bioconjugate pneumococcal vaccine
arm group label: Pneumo1-target dose
arm group type: Experimental
description: Arm C: intramuscular injection monovalent bioconjugate pneumococcal vaccine
arm group label: Pneumovax23
arm group type: Active Comparator
description: Arm D: intramuscular injection multivalent plain polysaccharide vaccine
intervention type: Biological
intervention name: Bioconjugate pneumococcal vaccine
description: Bioconjuagte vaccine against bacterial pneumococcal infection
arm group label: Pneumo1-low dose
arm group label: Pneumo1-mid dose
arm group label: Pneumo1-target dose
intervention type: Biological
intervention name: Multivalent plain polysaccharide vaccine
description: Multivalent plain polysaccharide vaccine against bacterial pneumococcal infection
arm group label: Pneumovax23
criteria: 
gender: All
minimum age: 60 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Leidig, MD
role: Principal Investigator
affiliation: CRS Mönchengladbach
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pneumonia, Bacterial
mesh term: Pneumonia, Pneumococcal
mesh term: Vaccines
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: Undecided