<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/NCT03014089</url>
  </required_header>
  <id_info>
    <org_study_id>mRNA-1325-P101</org_study_id>
    <secondary_id>HHSO100201600029C</secondary_id>
    <nct_id>NCT03014089</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects</brief_title>
  <official_title>A Phase 1, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of mRNA 1325 Zika Vaccine in Healthy Adults in a Non-endemic Zika Region</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ModernaTX, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biomedical Advanced Research and Development Authority</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>ModernaTX, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in&#xD;
      healthy adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 21, 2016</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">July 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI) and adverse events considered related to study drug</measure>
    <time_frame>Through 13 months of study participation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of seroconversion to ZIKV measured by neutralization assay in comparison with baseline sample</measure>
    <time_frame>Through 13 months of study participation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Zika Virus</condition>
  <arm_group>
    <arm_group_label>mRNA-1325</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.9% sodium chloride</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>mRNA-1325</intervention_name>
    <description>Escalating dose levels</description>
    <arm_group_label>mRNA-1325</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion&#xD;
&#xD;
          -  18 to 49 years of age&#xD;
&#xD;
          -  Body mass index between 18 and 35 kg/m2&#xD;
&#xD;
          -  In good health as determined by medical history&#xD;
&#xD;
          -  Female subjects must be non pregnant and non lactating and meet one of the following&#xD;
             criteria: a) post menopausal b) surgically sterile&#xD;
&#xD;
          -  Women of childbearing potential must agree to be heterosexually inactive or agree to&#xD;
             consistently use any of the following methods of contraception from at least 21 days&#xD;
             prior to enrollment and through 3 months after the final vaccination&#xD;
&#xD;
          -  Male subjects must use an acceptable method of birth control throughout the entire&#xD;
             study and agree to refrain from donation of sperm from the time of first vaccination&#xD;
             until 3 months following the last vaccination&#xD;
&#xD;
          -  Agrees to comply with the study procedures and provides written informed consent&#xD;
&#xD;
          -  Has access to a consistent and reliable means of telephone contact and agrees to stay&#xD;
             in contact with the study site for the duration of the study, to provide updated&#xD;
             contact information as necessary, and has no current plans to move from the study area&#xD;
             for the duration of the study&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care&#xD;
&#xD;
          -  A history of active cancer (malignancy) in the last 10 years&#xD;
&#xD;
          -  Female of childbearing potential and has a positive pregnancy test at screening or on&#xD;
             the day of vaccination&#xD;
&#xD;
          -  Administration of an investigational product within 60 days, or 5 half-lives,&#xD;
             whichever is longer&#xD;
&#xD;
          -  Administration of any live attenuated vaccines within 4 weeks before enrollment or&#xD;
             inactive vaccines within 2 weeks before enrollment, or plans to receive any vaccine&#xD;
             during the active vaccination period&#xD;
&#xD;
          -  Prior administration of a vaccine for Zika or dengue vaccine, a history of confirmed&#xD;
             Zika or dengue infection, or has lived in or visited any Zika-endemic area greater&#xD;
             than 4 weeks in duration&#xD;
&#xD;
          -  Prior administration of investigational agent using formulations similar to mRNA-1325&#xD;
&#xD;
          -  A history of hypersensitivity or serious reactions to previous vaccinations&#xD;
&#xD;
          -  Any known or suspected autoimmune disease or immunosuppressive condition, acquired or&#xD;
             congenital, as determined by medical history and/or physical examination&#xD;
&#xD;
          -  A history of inflammatory arthritis&#xD;
&#xD;
          -  Any neurologic disorder&#xD;
&#xD;
          -  A history of febrile disease with arthritis or arthralgia within 2 weeks of dose&#xD;
             administration.&#xD;
&#xD;
          -  Prior administration of immunoglobulins and/or any blood products within the 3 months&#xD;
             preceding the administration of the study drug or plans to receive such products at&#xD;
             any time during the study&#xD;
&#xD;
          -  Any chronic administration of an immunosuppressant or other immune modifying drug&#xD;
&#xD;
          -  Any acute illness at the time of enrollment&#xD;
&#xD;
          -  Any significant disorder of coagulation requiring ongoing or intermittent treatment&#xD;
&#xD;
          -  A history of idiopathic urticaria&#xD;
&#xD;
          -  A history of alcohol abuse or drug addiction&#xD;
&#xD;
          -  A positive test result for drugs of abuse&#xD;
&#xD;
          -  The subject has any abnormality or permanent body art (eg, tattoo) that, in the&#xD;
             opinion of the investigator, would obstruct the ability to observe local reactions at&#xD;
             the injection site&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, would pose a health risk to&#xD;
             the subject if enrolled or could interfere with evaluation of the study drug or&#xD;
             interpretation of study results&#xD;
&#xD;
          -  A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or&#xD;
             human immunodeficiency virus types 1 or 2 antibodies&#xD;
&#xD;
          -  Donation of blood or blood products &gt; 450 mL within 30 days of dosing.&#xD;
&#xD;
          -  Abnormal vital signs or screening safety laboratory test results including liver&#xD;
             enzyme tests&#xD;
&#xD;
          -  Is an employee or first degree relative of the Sponsor, CRO, or study site personnel&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32934</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>December 6, 2019</last_update_submitted>
  <last_update_submitted_qc>December 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mRNA-1325</keyword>
  <keyword>Zika vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zika Virus Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03014089
org study id: mRNA-1325-P101
secondary id: HHSO100201600029C
nct id: NCT03014089
lead sponsor: 
collaborator: 
has dmc: Yes
The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in
      healthy adult subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI) and adverse events considered related to study drug
time frame: Through 13 months of study participation
measure: Frequency of seroconversion to ZIKV measured by neutralization assay in comparison with baseline sample
time frame: Through 13 months of study participation
arm group label: mRNA-1325
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
description: 0.9% sodium chloride
intervention type: Biological
intervention name: mRNA-1325
description: Escalating dose levels
arm group label: mRNA-1325
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Zika Virus Infection
sharing ipd: No