<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/NCT02238756</url>
  </required_header>
  <id_info>
    <org_study_id>CV-8102-201</org_study_id>
    <secondary_id>2013-004514-18</secondary_id>
    <nct_id>NCT02238756</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults</brief_title>
  <official_title>Phase I Safety and Tolerability Trial of Single and Repeat Doses of the RNA-based Adjuvant CV8102 Alone and in Combination With a Licensed Rabies Virus Vaccine in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CureVac</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CureVac</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical trial is to investigate the safety and tolerability of IM&#xD;
      administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in&#xD;
      humans.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with serious and non serious adverse events</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum tolerated dose (MTD) of CV8102 within the dose range of 25 µg to 250 µg.</measure>
    <time_frame>Up to day 49</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MTD of CV8102 in combination with rabies vaccine</measure>
    <time_frame>Up to Day 49</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccination-elicited serum rabies VNTs among the dose groups</measure>
    <time_frame>Up to day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccination-elicited innate and adaptive immune responses</measure>
    <time_frame>Up to Day 35</time_frame>
    <description>Evaluation of corresponding serum and blood parameters (e.g. relevant cytokines, chemokines, immune effector molecules and lymphocyte phenotyping)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Rabies</condition>
  <arm_group>
    <arm_group_label>CV8102</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Rabipur</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CV8102 + Rabipur</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CV8102</intervention_name>
    <description>Subjects will receive 2 intramuscular doses of CV8102 given 21 days apart</description>
    <arm_group_label>CV8102</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rabipur</intervention_name>
    <description>Subjects will receive 2 intramuscular doses of Rabipur given 21 days apart</description>
    <arm_group_label>Rabipur</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CV8102 + Rabipur</intervention_name>
    <description>Subjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart</description>
    <arm_group_label>CV8102 + Rabipur</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Compliant with protocol procedures and available for clinical F/U until the&#xD;
             protocol-defined end of the trial&#xD;
&#xD;
          2. Physical examination and laboratory results without clinically significant findings&#xD;
&#xD;
          3. Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2&#xD;
&#xD;
          4. Subjects must use reliable forms of contraception (barrier method with spermicidal&#xD;
             agent or true abstinence) and must refrain from sperm donation during treatment and&#xD;
             the 4-week F/U period after the last treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of any investigational or non-registered product (adjuvant, drug) other than&#xD;
             CV8102 within 4 weeks preceding the administration of the CV8102, or planned use of&#xD;
             any such agent during the trial period&#xD;
&#xD;
          2. Subject has received any licensed or non-licensed vaccines within 4 weeks prior to the&#xD;
             administration of CV8102 alone or in combination with the licensed rabies vaccine or&#xD;
             planned vaccinations during the trial period&#xD;
&#xD;
          3. Any treatment with immunosuppressants or other immune-modifying drugs within 6 months&#xD;
             prior to the administration of CV8102 alone or in combination with the licensed rabies&#xD;
             vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside&#xD;
             the vaccination area, will be permitted&#xD;
&#xD;
          4. Any medically diagnosed or suspected immune deficient condition based on medical&#xD;
             history and physical examination&#xD;
&#xD;
          5. History of autoimmune disease or suspected autoimmune disease based on medical history&#xD;
             and physical examination that cannot be ruled out based on further examinations&#xD;
&#xD;
          6. Administration of immunoglobulins (Igs) and/or any blood products within the 3 months&#xD;
             preceding the administration of CV8102 or licensed rabies vaccine&#xD;
&#xD;
          7. Acute disease at the time of enrolment. Acute disease is defined as the presence of&#xD;
             any acute condition including but not limited to non-febrile or febrile common colds,&#xD;
             urinary tract infections, inflammatory, allergic or traumatic conditions that may&#xD;
             interfere with safety assessment of the investigational products&#xD;
&#xD;
          8. Presence or evidence of significant acute or chronic disease, in particular heart&#xD;
             disease including coronary artery disease and chronic pulmonary diseases (e.g.,&#xD;
             chronic obstructive pulmonary disease [COPD]); uncontrolled medical or psychiatric&#xD;
             illness (subjects with uncomplicated chronic diagnoses stable and treated for ≥ 3&#xD;
             months e.g., mild hypertension well-controlled with medication, may be enrolled -&#xD;
             provided the condition and its therapy are known not to be associated with an&#xD;
             immunocompromised state or an autoimmune disease)&#xD;
&#xD;
          9. Major congenital defects&#xD;
&#xD;
         10. Known allergy to any component (or closely related substance) of the licensed rabies&#xD;
             vaccine product&#xD;
&#xD;
         11. Known type I allergy to beta-lactam antibiotics&#xD;
&#xD;
         12. Evidence of current alcohol or drug abuse&#xD;
&#xD;
         13. History of any neurological disorders or seizures&#xD;
&#xD;
         14. Known seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV)&#xD;
             (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV)&#xD;
&#xD;
         15. Foreseeable non-compliance with protocol as judged by the Investigator&#xD;
&#xD;
         16. History of any life-threatening anaphylactic reactions&#xD;
&#xD;
         17. Subjects with impaired coagulation in whom an IM injection is contraindicated.&#xD;
&#xD;
             Additional exclusion criteria for subjects participating in the (adjuvanted) rabies&#xD;
             vaccination part:&#xD;
&#xD;
         18. Subject has previously received any investigational or licensed rabies vaccine&#xD;
&#xD;
         19. Intending to travel to regions/countries for which rabies vaccinations are recommended&#xD;
             or where high risk of infection exists according to travel recommendations by the&#xD;
             German Society of Tropical Medicine and International Health (DTG) during the trial&#xD;
             and F/U period&#xD;
&#xD;
         20. Subject is taking chloroquine for malaria treatment or prophylaxis.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingo Meyer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CRS Clinical Research Services Mönchengladbach GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRS Clinical Research Services Mönchengladbach GmbH</name>
      <address>
        <city>Mönchengladbach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>June 5, 2018</last_update_submitted>
  <last_update_submitted_qc>June 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rabies</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/NCT02238756
org study id: CV-8102-201
secondary id: 2013-004514-18
nct id: NCT02238756
lead sponsor: 
has dmc: Yes
The purpose of this clinical trial is to investigate the safety and tolerability of IM
      administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in
      humans.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of subjects with serious and non serious adverse events
time frame: Up to 12 months
measure: Maximum tolerated dose (MTD) of CV8102 within the dose range of 25 µg to 250 µg.
time frame: Up to day 49
measure: MTD of CV8102 in combination with rabies vaccine
time frame: Up to Day 49
measure: Vaccination-elicited serum rabies VNTs among the dose groups
time frame: Up to day 35
measure: Vaccination-elicited innate and adaptive immune responses
time frame: Up to Day 35
description: Evaluation of corresponding serum and blood parameters (e.g. relevant cytokines, chemokines, immune effector molecules and lymphocyte phenotyping)
arm group label: CV8102
arm group type: Experimental
arm group label: Rabipur
arm group type: Active Comparator
arm group label: CV8102 + Rabipur
arm group type: Experimental
intervention type: Biological
intervention name: CV8102
description: Subjects will receive 2 intramuscular doses of CV8102 given 21 days apart
arm group label: CV8102
intervention type: Biological
intervention name: Rabipur
description: Subjects will receive 2 intramuscular doses of Rabipur given 21 days apart
arm group label: Rabipur
intervention type: Biological
intervention name: CV8102 + Rabipur
description: Subjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart
arm group label: CV8102 + Rabipur
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ingo Meyer, MD
role: Principal Investigator
affiliation: CRS Clinical Research Services Mönchengladbach GmbH
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Rabies