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/NCT05975099</url>
    </required_header>
    <id_info>
      <org_study_id>mRNA-1975/1982-P101</org_study_id>
      <nct_id>NCT05975099</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age</brief_title>
    <official_title>A Phase 1/2, Randomized, Observer-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Immunogenicity of Heptavalent mRNA-1975 (SR1-7) and Monovalent mRNA-1982 (SR1) in Parallel Against Lyme Disease in Healthy Participants 18 Through 70 Years of Age</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>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the safety and immunogenicity in parallel of&#xD;
        heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 26, 2023</start_date>
    <completion_date type="Anticipated">March 12, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 12, 2026</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)</measure>
      <time_frame>Up to Day 175 (7 days after each study injection)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants With Unsolicited Adverse Events (AEs)</measure>
      <time_frame>Up to Day 196 (28 days after each study injection)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants With Medically Attended AEs</measure>
      <time_frame>Day 1 through Day 365 (6 months after the last study injection)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with AEs of Special Interest, Serious AEs, and AEs Leading to Discontinuation of Study Injection or Study Participation</measure>
      <time_frame>Day 1 through Day 841 (End of Study)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Titer of Anti-outer Surface Protein A (anti-OspA) Binding Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay or a Similar Method</measure>
      <time_frame>Days 1, 29, 85, and 197</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Titer at Days 29, 85, and 197 Compared to Day 1 (Baseline)</measure>
      <time_frame>Day 1 (Baseline), Days 29, 85, and 197</time_frame>
    </secondary_outcome>
    <number_of_arms>8</number_of_arms>
    <enrollment type="Anticipated">800</enrollment>
    <condition>Lyme Disease</condition>
    <arm_group>
      <arm_group_label>mRNA-1975: Dose 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1975: Dose 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1975: Dose 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1975: Dose 4</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1982: Dose 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1982: Dose 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1982: Dose 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-1975</intervention_name>
      <description>Dispersion delivered IM</description>
      <arm_group_label>mRNA-1975: Dose 1</arm_group_label>
      <arm_group_label>mRNA-1975: Dose 2</arm_group_label>
      <arm_group_label>mRNA-1975: Dose 3</arm_group_label>
      <arm_group_label>mRNA-1975: Dose 4</arm_group_label>
      <other_name>SR1-7</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-1982</intervention_name>
      <description>Dispersion delivered IM</description>
      <arm_group_label>mRNA-1982: Dose 1</arm_group_label>
      <arm_group_label>mRNA-1982: Dose 2</arm_group_label>
      <arm_group_label>mRNA-1982: Dose 3</arm_group_label>
      <other_name>SR1</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Solution delivered IM</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body mass index of 18 to 39 kilograms/square meter (inclusive) at the Screening Visit.&#xD;
  &#xD;
            -  Participants of nonchildbearing potential may be enrolled in the study.&#xD;
  &#xD;
            -  For female participants of childbearing potential: negative pregnancy test, adequate&#xD;
               contraception or has abstained from all activities that could result in pregnancy&#xD;
               during the study intervention period, and agreement to continue adequate contraception&#xD;
               or abstinence through 3 months following last study injection.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have chronic illness related to Lyme disease or an active symptomatic Lyme disease&#xD;
               infection as suspected or diagnosed by a physician.&#xD;
  &#xD;
            -  Received treatment for Lyme disease within the prior 3 months.&#xD;
  &#xD;
            -  Had previous vaccination against Lyme disease or participated in the past in any&#xD;
               vaccine study for Lyme disease.&#xD;
  &#xD;
            -  Had a tick bite within 4 weeks prior to the study injection visit.&#xD;
  &#xD;
            -  Dermatologic conditions that could affect local solicited AR assessments (for example,&#xD;
               tattoos; psoriasis patches affecting skin over the deltoid areas).&#xD;
  &#xD;
            -  Received systemic immunosuppressants for &gt;14 days in total within 180 days prior to&#xD;
               the Screening Visit (for corticosteroids, ≥10 milligrams/day of prednisone or&#xD;
               equivalent) or is anticipating the need for systemic immunosuppressive treatment at&#xD;
               any time during participation in the study.&#xD;
  &#xD;
            -  History of myocarditis, pericarditis, or myopericarditis regardless of the timing of&#xD;
               past medical history.&#xD;
  &#xD;
            -  History of anaphylaxis, urticaria, or other significant adverse reaction requiring&#xD;
               medical intervention after receipt of a vaccine or intervention that includes one or&#xD;
               more of the same components contained in the study injection.&#xD;
  &#xD;
            -  Has received systemic immunoglobulins, long-acting biological therapies that affect&#xD;
               immune responses (for example, infliximab) or blood products within 90 days prior to&#xD;
               the Screening Visit or plans to receive them during the 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>70 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>Clinical Research Consulting, LLC</name>
        <address>
          <city>Milford</city>
          <state>Connecticut</state>
          <zip>06460</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Stamford Therapeutics Consortium</name>
        <address>
          <city>Stamford</city>
          <state>Connecticut</state>
          <zip>06905</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Chase Medical Research, LLC</name>
        <address>
          <city>Waterbury</city>
          <state>Connecticut</state>
          <zip>06708</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Jacksonville Center for Clinical Research</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32216</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>University Clinical Research-DeLand, LLC d/b/a Accel Research Sites</name>
        <address>
          <city>Lake Mary</city>
          <state>Florida</state>
          <zip>32746</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Research Atlanta, headlands LLC</name>
        <address>
          <city>Stockbridge</city>
          <state>Georgia</state>
          <zip>30281</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Johnson County Clin-Trials, Inc. (JCCT)</name>
        <address>
          <city>Lenexa</city>
          <state>Kansas</state>
          <zip>66219</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Centennial Medical Group</name>
        <address>
          <city>Elkridge</city>
          <state>Maryland</state>
          <zip>21075</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Advanced Primary and Geriatric Care</name>
        <address>
          <city>Rockville</city>
          <state>Maryland</state>
          <zip>20850</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>DM Clinical Research - Brookline</name>
        <address>
          <city>Brookline</city>
          <state>Massachusetts</state>
          <zip>02445</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Research Institute, Inc.</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55402</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research Providence</name>
        <address>
          <city>Omaha</city>
          <state>Nebraska</state>
          <zip>68134</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>ActivMed Research LLC</name>
        <address>
          <city>Portsmouth</city>
          <state>New Hampshire</state>
          <zip>03801</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Rochester Clinical Research, Inc.</name>
        <address>
          <city>Rochester</city>
          <state>New York</state>
          <zip>14609</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Lynn Health Science Institute</name>
        <address>
          <city>Oklahoma City</city>
          <state>Oklahoma</state>
          <zip>73112</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Hatboro Medical Associates/CCT Research</name>
        <address>
          <city>Hatboro</city>
          <state>Pennsylvania</state>
          <zip>19040</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research Providence</name>
        <address>
          <city>East Greenwich</city>
          <state>Rhode Island</state>
          <zip>02818</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Benchmark Research</name>
        <address>
          <city>Fort Worth</city>
          <state>Texas</state>
          <zip>76135</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>DM Clinical Research</name>
        <address>
          <city>Tomball</city>
          <state>Texas</state>
          <zip>77375</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Charlottesville Medical Research Center, LLC</name>
        <address>
          <city>Charlottesville</city>
          <state>Virginia</state>
          <zip>22911</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>mRNA-1975</keyword>
    <keyword>mRNA-1982</keyword>
    <keyword>Vaccine</keyword>
    <keyword>Lyme Disease Vaccine</keyword>
    <keyword>Messenger RNA</keyword>
    <keyword>Moderna</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lyme Disease</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/NCT05975099
  org study id: mRNA-1975/1982-P101
  nct id: NCT05975099
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the safety and immunogenicity in parallel of
        heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult
        participants.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
  time frame: Up to Day 175 (7 days after each study injection)
  measure: Number of Participants With Unsolicited Adverse Events (AEs)
  time frame: Up to Day 196 (28 days after each study injection)
  measure: Number of Participants With Medically Attended AEs
  time frame: Day 1 through Day 365 (6 months after the last study injection)
  measure: Number of Participants with AEs of Special Interest, Serious AEs, and AEs Leading to Discontinuation of Study Injection or Study Participation
  time frame: Day 1 through Day 841 (End of Study)
  measure: Geometric Mean Titer of Anti-outer Surface Protein A (anti-OspA) Binding Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay or a Similar Method
  time frame: Days 1, 29, 85, and 197
  measure: Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Titer at Days 29, 85, and 197 Compared to Day 1 (Baseline)
  time frame: Day 1 (Baseline), Days 29, 85, and 197
  arm group label: mRNA-1975: Dose 1
  arm group type: Experimental
  description: Participants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169.
  arm group label: mRNA-1975: Dose 2
  arm group type: Experimental
  description: Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169.
  arm group label: mRNA-1975: Dose 3
  arm group type: Experimental
  description: Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169.
  arm group label: mRNA-1975: Dose 4
  arm group type: Experimental
  description: Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169.
  arm group label: mRNA-1982: Dose 1
  arm group type: Experimental
  description: Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169.
  arm group label: mRNA-1982: Dose 2
  arm group type: Experimental
  description: Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.
  arm group label: mRNA-1982: Dose 3
  arm group type: Experimental
  description: Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.
  intervention type: Biological
  intervention name: mRNA-1975
  description: Dispersion delivered IM
  arm group label: mRNA-1975: Dose 1
  arm group label: mRNA-1975: Dose 2
  arm group label: mRNA-1975: Dose 3
  arm group label: mRNA-1975: Dose 4
  other name: SR1-7
  intervention type: Biological
  intervention name: mRNA-1982
  description: Dispersion delivered IM
  arm group label: mRNA-1982: Dose 1
  arm group label: mRNA-1982: Dose 2
  arm group label: mRNA-1982: Dose 3
  other name: SR1
  intervention type: Biological
  intervention name: Placebo
  description: Solution delivered IM
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Moderna Clinical Trials Support Center
  phone: 1-877-777-7187
  email: clinicaltrials@modernatx.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: 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
  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
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Lyme Disease