xml: <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/NCT05995275</url>
    </required_header>
    <id_info>
      <org_study_id>mRNA-1769-P101</org_study_id>
      <nct_id>NCT05995275</nct_id>
    </id_info>
    <brief_title>A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to &lt;50 Years of Age</brief_title>
    <official_title>A Randomised, Placebo-Controlled, Dose-Ranging, Observer-Blind Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of mRNA-1769 in Healthy Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ModernaTX, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ModernaTX, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to assess the safety, tolerability and immunogenicity of mRNA-1769&#xD;
        in healthy adult participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">February 14, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 14, 2025</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Through 7 Days After Each Investigational Medicinal Product (IMP)</measure>
      <time_frame>Up to Day 35</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Unsolicited Adverse Events (AEs) Through 7 Days After Each IMP</measure>
      <time_frame>Up to Day 57</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Medically-Attended AEs (MAAEs)</measure>
      <time_frame>Day 1 up to Day 395</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Adverse Events of Special Interest (AESIs)</measure>
      <time_frame>Day 1 up to Day 395</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Serious Adverse Events (SAEs)</measure>
      <time_frame>Day 1 up to Day 395</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with AEs Leading to Study and/or Treatment Discontinuation</measure>
      <time_frame>Day 1 up to Day 395</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Titer (GMT) of Neutralising Antibody (nAb) against Mpox Virus (MPXV) by Plaque reduction neutralisation test (PRNT)</measure>
      <time_frame>Days 1 and 43</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against MPXV</measure>
      <time_frame>Days 1 and 43</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Concentration of Binding Antibodies (bAbs) Against MPXV Antigens by Meso Scale Discovery (MSD) Assay</measure>
      <time_frame>Days 1, 29, 43, and 57</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants With Seroconversion Based on Binding Antibodies (bAb) Responses against MPXV</measure>
      <time_frame>Days 1, 29, 43, and 57</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Titer of Neutralising Antibody Against Vaccinia Virus (VACV) by Plaque Reduction Neutralisation Test (PRNT)</measure>
      <time_frame>Days 1 and 43</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against Vaccinia Virus</measure>
      <time_frame>Days 1 and 43</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Concentration of Binding Antibodies Against Vaccinia Virus Antigens by Meso Scale Discovery Assay</measure>
      <time_frame>Days 1, 29, 43, and 57</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants With Seroconversion Based on Binding Antibodies Responses Against Vaccinia Virus</measure>
      <time_frame>Days 1, 29, 43, and 57</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Smallpox</condition>
    <condition>Mpox</condition>
    <arm_group>
      <arm_group_label>mRNA-1769 Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive intramuscular (IM) injection of mRNA-1769 at Dose A on Day 1 and Day 29.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1769 Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive IM injection of mRNA-1769 at Dose B on Day 1 and Day 29.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1769 Dose C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive IM injection of mRNA-1769 at Dose C on Day 1 and Day 29.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive IM injection of placebo matched to mRNA-1769 on Day 1 and Day 29.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-1769</intervention_name>
      <description>Sterile liquid for injection</description>
      <arm_group_label>mRNA-1769 Dose A</arm_group_label>
      <arm_group_label>mRNA-1769 Dose B</arm_group_label>
      <arm_group_label>mRNA-1769 Dose C</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>0.9% sodium chloride injection (normal saline)</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Has a body mass index (BMI) between ≥18 kilogram per square meter (kg/m^2) to ≤39&#xD;
               kg/m^2.&#xD;
  &#xD;
            -  For female participants of childbearing potential: must have a negative highly&#xD;
               sensitive pregnancy test with 28 days before the first dose of study drug, uses&#xD;
               approved contraception during the study intervention period and for at least 3 months&#xD;
               after the last dose of study drug, and not currently breastfeeding.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of smallpox vaccination, vaccination with any poxvirus-based vaccine, history&#xD;
               of of/or recent exposure to Mpox (MPX) (defined as close contact with a confirmed case&#xD;
               of MPX within the past 14 days).&#xD;
  &#xD;
            -  Participant should not have any significant, progressive, unstable, or uncontrolled&#xD;
               clinical condition, including any condition that may affect participant safety,&#xD;
               assessment of safety endpoints, assessment of immune response, or adherence to study&#xD;
               procedures per Investigator judgement.&#xD;
  &#xD;
            -  Participant is undergoing investigations for a potential chronic medical disorder.&#xD;
  &#xD;
            -  Bleeding disorder considered a contraindication to IM injection or phlebotomy.&#xD;
  &#xD;
            -  Dermatologic conditions that could affect local solicited AR assessments.&#xD;
  &#xD;
            -  History of anaphylactic reaction or allergic reactions that required medical&#xD;
               intervention following any vaccine.&#xD;
  &#xD;
            -  Known or suspected allergy to any component of mRNA-1769.&#xD;
  &#xD;
            -  History of malignancy within previous 10 years (excluding non-melanoma skin cancer).&#xD;
  &#xD;
            -  Participant has any medical, psychiatric, or occupational condition, including&#xD;
               reported history of drug or alcohol abuse, that, in the opinion of the Investigator,&#xD;
               might pose additional risk due to participation in the study or could interfere with&#xD;
               the interpretation of study results.&#xD;
  &#xD;
            -  Participant has received systemic immunosuppressants or immune-modifying drugs for &gt;14&#xD;
               days in total within 6 months prior to Screening (for corticosteroids, ≥10 mg/day of&#xD;
               prednisone or equivalent) or is anticipating the need for immunosuppressive treatment&#xD;
               at any time during participation in the study. Topical tacrolimus is allowed if not&#xD;
               used within 14 days prior to the day of enrolment. Participants may be rescheduled for&#xD;
               enrolment if they no longer meet this criterion within the Screening Period. Inhaled,&#xD;
               nasal, and topical steroids are allowed.&#xD;
  &#xD;
            -  Receipt or planned receipt of: Any vaccine(s), authorised or approved by local health&#xD;
               agency, including mRNA vaccine, ≤28 days prior to the first injection through 28 days&#xD;
               after the last dose of investigational (IMP).&#xD;
  &#xD;
            -  Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months&#xD;
               prior to the first injection up to the end of the study.&#xD;
  &#xD;
            -  Participated in an interventional study/received an investigational product within 28&#xD;
               days prior to the Screening Period or plans to do so while enroled in this study.&#xD;
  &#xD;
          Note: Other inclusion and exclusion criteria may apply.&#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>
    <overall_contact>
      <last_name>Moderna Clinical Trials Support Center</last_name>
      <phone>1-877-777-7187</phone>
      <email>clinicaltrials@modernatx.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bradford Teaching Hospitals NHS Foundation Trust</name>
        <address>
          <city>Bradford</city>
          <zip>BD9 6RJ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>University Hospitals Bristol and Weston NHS Foundation Trust</name>
        <address>
          <city>Bristol</city>
          <zip>BS2 8DX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Lakeside Healthcare Research</name>
        <address>
          <city>Corby</city>
          <zip>NN17 2UR</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>University Hospitals of Leicester</name>
        <address>
          <city>Leicester</city>
          <zip>LE1 5WW</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Liverpool University Hospitals NHS Foundation Trust</name>
        <address>
          <city>Liverpool</city>
          <zip>L7 8XP</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Barts Health NHS Trust</name>
        <address>
          <city>London</city>
          <zip>E1 4DG</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>University College London Hospitals</name>
        <address>
          <city>London</city>
          <zip>NW1 2PG</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Royal Free London NHS Foundation Trust</name>
        <address>
          <city>London</city>
          <zip>NW3 2QG</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Chelsea and Westminster Hospital NHS Foundation Trust</name>
        <address>
          <city>London</city>
          <zip>SW10 9NH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Medicines Evaluation Unit</name>
        <address>
          <city>Manchester</city>
          <zip>M23 9QZ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)</name>
        <address>
          <city>Oxford</city>
          <zip>OX3 7LE</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>North Wales Clinical Research Facility Centre</name>
        <address>
          <city>Wrexham</city>
          <zip>LL13 7YP</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>mRNA-1769 vaccine</keyword>
    <keyword>mRNA-1769</keyword>
    <keyword>Moderna</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Smallpox</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995275
  org study id: mRNA-1769-P101
  nct id: NCT05995275
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to assess the safety, tolerability and immunogenicity of mRNA-1769
        in healthy adult participants.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Through 7 Days After Each Investigational Medicinal Product (IMP)
  time frame: Up to Day 35
  measure: Number of Unsolicited Adverse Events (AEs) Through 7 Days After Each IMP
  time frame: Up to Day 57
  measure: Number of Participants with Medically-Attended AEs (MAAEs)
  time frame: Day 1 up to Day 395
  measure: Number of Participants with Adverse Events of Special Interest (AESIs)
  time frame: Day 1 up to Day 395
  measure: Number of Participants with Serious Adverse Events (SAEs)
  time frame: Day 1 up to Day 395
  measure: Number of Participants with AEs Leading to Study and/or Treatment Discontinuation
  time frame: Day 1 up to Day 395
  measure: Geometric Mean Titer (GMT) of Neutralising Antibody (nAb) against Mpox Virus (MPXV) by Plaque reduction neutralisation test (PRNT)
  time frame: Days 1 and 43
  measure: Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against MPXV
  time frame: Days 1 and 43
  measure: Geometric Mean Concentration of Binding Antibodies (bAbs) Against MPXV Antigens by Meso Scale Discovery (MSD) Assay
  time frame: Days 1, 29, 43, and 57
  measure: Percentage of Participants With Seroconversion Based on Binding Antibodies (bAb) Responses against MPXV
  time frame: Days 1, 29, 43, and 57
  measure: Geometric Mean Titer of Neutralising Antibody Against Vaccinia Virus (VACV) by Plaque Reduction Neutralisation Test (PRNT)
  time frame: Days 1 and 43
  measure: Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against Vaccinia Virus
  time frame: Days 1 and 43
  measure: Geometric Mean Concentration of Binding Antibodies Against Vaccinia Virus Antigens by Meso Scale Discovery Assay
  time frame: Days 1, 29, 43, and 57
  measure: Percentage of Participants With Seroconversion Based on Binding Antibodies Responses Against Vaccinia Virus
  time frame: Days 1, 29, 43, and 57
  arm group label: mRNA-1769 Dose A
  arm group type: Experimental
  description: Participants will receive intramuscular (IM) injection of mRNA-1769 at Dose A on Day 1 and Day 29.
  arm group label: mRNA-1769 Dose B
  arm group type: Experimental
  description: Participants will receive IM injection of mRNA-1769 at Dose B on Day 1 and Day 29.
  arm group label: mRNA-1769 Dose C
  arm group type: Experimental
  description: Participants will receive IM injection of mRNA-1769 at Dose C on Day 1 and Day 29.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive IM injection of placebo matched to mRNA-1769 on Day 1 and Day 29.
  intervention type: Biological
  intervention name: mRNA-1769
  description: Sterile liquid for injection
  arm group label: mRNA-1769 Dose A
  arm group label: mRNA-1769 Dose B
  arm group label: mRNA-1769 Dose C
  intervention type: Other
  intervention name: Placebo
  description: 0.9% sodium chloride injection (normal saline)
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 49 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Moderna Clinical Trials Support Center
  phone: 1-877-777-7187
  email: clinicaltrials@modernatx.com
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Smallpox