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/NCT06033261</url>
    </required_header>
    <id_info>
      <org_study_id>mRNA-1608-P101</org_study_id>
      <nct_id>NCT06033261</nct_id>
    </id_info>
    <brief_title>A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes</brief_title>
    <official_title>A Phase 1/2, Randomized, Observer-Blind, Controlled, Dose-Ranging Study of mRNA-1608, an HSV-2 Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes</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 generate safety and immunogenicity data and establish a&#xD;
        proof-of-concept of clinical benefit of the mRNA-1608 vaccine candidate.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants with a history of recurrent genital herpes will be randomly assigned in a&#xD;
        1:1:1:1 ratio to receive mRNA-1608 at 1 of the 3 dose levels or control (BEXSERO)&#xD;
        administered as 2 doses at 0 and 2 months (Day 1 and Day 57).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 6, 2023</start_date>
    <completion_date type="Anticipated">June 4, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 4, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)</measure>
      <time_frame>Up to Day 64 (7 days after each injection)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Unsolicited Adverse Events (AEs)</measure>
      <time_frame>Up to Day 85 (28 days after each injection)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Serious Adverse Events (SAEs)</measure>
      <time_frame>Day 1 to Day 393 (end of study [EoS])</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Adverse Events of Special Interest (AESIs)</measure>
      <time_frame>Day 1 to Day 393 (EoS)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with AEs Leading to Discontinuation From Study</measure>
      <time_frame>Day 1 to Day 393 (EoS)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Medically-Attended AEs (MAAEs)</measure>
      <time_frame>Day 1 through 6 months after last study injection (Day 225)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection</measure>
      <time_frame>Day 71 to Day 225</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 12 Months After Second Study Injection</measure>
      <time_frame>Day 71 to Day 393</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in Genital Herpes Lesion Rate (Proportion of Days With Lesions Present)</measure>
      <time_frame>Baseline (Day -27 to Day 1), Day 85 to Day 113</time_frame>
      <description>To calculate the 'Change from Baseline', the herpes lesion rate during the timeframe of Day 85 to Day 113 will be compared against the herpes lesion rate during the timeframe of Day -27 to Day 1 (Baseline).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in Genital Herpes Lesion Rate (Proportion of Days With Lesions Present)</measure>
      <time_frame>Baseline (Day -27 to Day 1), Day 197 to Day 225</time_frame>
      <description>To calculate the 'Change from Baseline', the herpes lesion rate during the timeframe of Day 197 to Day 225 will be compared against the herpes lesion rate during the timeframe of Day -27 to Day 1 (Baseline).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Proportion of HSV-2 Deoxyribonucleic acid [DNA] Positive Anogenital Swabs)</measure>
      <time_frame>Baseline (Day -27 to Day 1), Day 85 to Day 113</time_frame>
      <description>To calculate the 'Change from Baseline', the HSV-2 genital shedding rate during the timeframe of Day 85 to Day 113 will be compared against the HSV-2 genital shedding rate during the timeframe of Day -27 to Day 1 (Baseline).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Proportion of HSV-2 DNA Positive Anogenital Swabs)</measure>
      <time_frame>Baseline (Day -27 to Day 1), Day 197 to Day 225</time_frame>
      <description>To calculate the 'Change from Baseline', the HSV-2 genital shedding rate during the timeframe of Day 197 to Day 225 will be compared against the HSV-2 genital shedding rate during the timeframe of Day -27 to Day 1 (Baseline).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Titer (GMT) of mRNA-1608 Antigen-Specific Binding Antibodies (bAbs) at 1 and 6 Months After the Second Study Injection</measure>
      <time_frame>Days 85 and 225</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric Mean Fold Rise (GMFR) of mRNA-1608 Antigen-Specific bAbs From Baseline to 1 and 6 Months After the Second Study Injection</measure>
      <time_frame>Baseline (Day 1), Days 85 and 225</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Vaccine Seroresponse</measure>
      <time_frame>Baseline (Day 1), Days 85 and 225</time_frame>
      <description>Seroresponse is defined by an increase in HSV-2 bAb levels at Day 85 and Day 225 ≥4-fold if baseline level is above the lower level of quantitation (LLOQ) or ≥4 × LLOQ if baseline bAb level is &lt;LLOQ prior to study injection.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Genital Herpes</condition>
    <arm_group>
      <arm_group_label>mRNA-1608 Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 2 intramuscular (IM) injections of mRNA-1608 at Dose Level A, each dose administered at 0 and 2 months (Day 1 and Day 57).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1608 Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 2 IM injections of mRNA-1608 at Dose Level B, each dose administered at 0 and 2 months (Day 1 and Day 57).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mRNA-1608 Dose C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 2 IM injections of mRNA-1608 at Dose Level C, each dose administered at 0 and 2 months (Day 1 and Day 57).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BEXSERO</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants will receive 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57).</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>mRNA-1608</intervention_name>
      <description>Sterile liquid for injection</description>
      <arm_group_label>mRNA-1608 Dose A</arm_group_label>
      <arm_group_label>mRNA-1608 Dose B</arm_group_label>
      <arm_group_label>mRNA-1608 Dose C</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>BEXSERO</intervention_name>
      <description>A vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B.</description>
      <arm_group_label>BEXSERO</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant has a diagnosis of genital HSV-2 infection for at least 1 year before the&#xD;
               Screening Visit.&#xD;
  &#xD;
            -  Seropositive for HSV-2 as determined by Western Blot.&#xD;
  &#xD;
            -  Participant has a history of recurrent genital herpes defined as at least 3 and no&#xD;
               more than 9 reported genital herpes recurrences in the 12 months preceding the&#xD;
               Screening Visit, or if currently on suppressive therapy, prior to initiation of&#xD;
               suppressive therapy.&#xD;
  &#xD;
            -  Willing to refrain from taking suppressive antiviral therapy from the Screening Visit&#xD;
               until the end of the study.&#xD;
  &#xD;
            -  Willing to refrain from the use of episodic antiviral therapy during the three 28-day&#xD;
               anogenital swabbing periods. Episodic therapy may be used outside the three 28-day&#xD;
               swabbing periods.&#xD;
  &#xD;
            -  For female participants of childbearing potential: negative pregnancy test, adequate&#xD;
               contraception, and not currently breastfeeding.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior immunization with a vaccine containing HSV antigens.&#xD;
  &#xD;
            -  History of any form of ocular HSV infection, HSV-related erythema multiforme, or&#xD;
               HSV-related neurological complications.&#xD;
  &#xD;
            -  History of genital HSV-1 infection.&#xD;
  &#xD;
            -  History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) types 1 or&#xD;
               2 (HIV-1, HIV-2).&#xD;
  &#xD;
            -  Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of&#xD;
               any mRNA vaccine(s) or any components of the mRNA vaccines.&#xD;
  &#xD;
            -  Previously received BEXSERO or other vaccine to prevent serogroup B meningococcal&#xD;
               disease (also known as meningitis B).&#xD;
  &#xD;
            -  History of allergic disease or reactions likely to be exacerbated by any component of&#xD;
               BEXSERO vaccine.&#xD;
  &#xD;
            -  Has received or plans to receive any licensed or authorized vaccine, including&#xD;
               COVID-19 vaccines, ≤ 28 days prior to the first study injection (Day 1), or plans to&#xD;
               receive a licensed or authorized vaccine within 28 days before or after study&#xD;
               injection with the exception of licensed influenza vaccines, which may be received&#xD;
               more than 14 days before or after any study injection.&#xD;
  &#xD;
          Note: Other inclusion and exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 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>University of Alabama at Birmingham</name>
        <address>
          <city>Birmingham</city>
          <state>Alabama</state>
          <zip>35205</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Noble Clinical Research</name>
        <address>
          <city>Tucson</city>
          <state>Arizona</state>
          <zip>85704</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Cedars-Sinai Medical Center/Carbon Health</name>
        <address>
          <city>Beverly Hills</city>
          <state>California</state>
          <zip>90211</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Artemis Institute for Clinical Research</name>
        <address>
          <city>Riverside</city>
          <state>California</state>
          <zip>92503</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Acclaim Clinical Research</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92120</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Multi-Therapeutic Research Associates, Inc.</name>
        <address>
          <city>Lake City</city>
          <state>Florida</state>
          <zip>32055</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Suncoast Research Associates, LLC</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33173</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>University of Illinois Medical Center</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60612</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Johnson County Clin-Trials (JCCT)</name>
        <address>
          <city>Lenexa</city>
          <state>Kansas</state>
          <zip>66219</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Heartland Research Associates LLC</name>
        <address>
          <city>Newton</city>
          <state>Kansas</state>
          <zip>67114</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Fenway Health</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>The Center for Pharmaceutical Research</name>
        <address>
          <city>Kansas City</city>
          <state>Missouri</state>
          <zip>64114</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research</name>
        <address>
          <city>Grand Island</city>
          <state>Nebraska</state>
          <zip>68803</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research</name>
        <address>
          <city>Norfolk</city>
          <state>Nebraska</state>
          <zip>68701</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Rochester Clinical Research</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>University of North Carolina (UNC) - Kidney Center (UNCKC)</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>M3 Wake Research, Inc.</name>
        <address>
          <city>Raleigh</city>
          <state>North Carolina</state>
          <zip>27612</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>Velocity Clinical Research, Austin</name>
        <address>
          <city>Cedar Park</city>
          <state>Texas</state>
          <zip>78613</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Helios CR, Inc Fort Worth</name>
        <address>
          <city>Fort Worth</city>
          <state>Texas</state>
          <zip>76107</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>DM Clinical Research</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77081</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Sun Research Institute</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78215</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Texas Center for Drug Development, INC</name>
        <address>
          <city>Tomball</city>
          <state>Texas</state>
          <zip>77064</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Health Research of Hampton Roads</name>
        <address>
          <city>Newport News</city>
          <state>Virginia</state>
          <zip>23606</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>University of Washington Virology Research Clinic</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HSV-2</keyword>
    <keyword>Herpes Simplex Virus Type 2</keyword>
    <keyword>HSV-2 vaccine</keyword>
    <keyword>Genital Herpes</keyword>
    <keyword>mRNA-1608</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Herpes Simplex</mesh_term>
      <mesh_term>Herpes Genitalis</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/NCT06033261
  org study id: mRNA-1608-P101
  nct id: NCT06033261
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to generate safety and immunogenicity data and establish a
        proof-of-concept of clinical benefit of the mRNA-1608 vaccine candidate.
  Participants with a history of recurrent genital herpes will be randomly assigned in a
        1:1:1:1 ratio to receive mRNA-1608 at 1 of the 3 dose levels or control (BEXSERO)
        administered as 2 doses at 0 and 2 months (Day 1 and Day 57).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
  time frame: Up to Day 64 (7 days after each injection)
  measure: Number of Participants with Unsolicited Adverse Events (AEs)
  time frame: Up to Day 85 (28 days after each injection)
  measure: Number of Participants with Serious Adverse Events (SAEs)
  time frame: Day 1 to Day 393 (end of study [EoS])
  measure: Number of Participants with Adverse Events of Special Interest (AESIs)
  time frame: Day 1 to Day 393 (EoS)
  measure: Number of Participants with AEs Leading to Discontinuation From Study
  time frame: Day 1 to Day 393 (EoS)
  measure: Number of Participants with Medically-Attended AEs (MAAEs)
  time frame: Day 1 through 6 months after last study injection (Day 225)
  measure: Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection
  time frame: Day 71 to Day 225
  measure: Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 12 Months After Second Study Injection
  time frame: Day 71 to Day 393
  measure: Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in Genital Herpes Lesion Rate (Proportion of Days With Lesions Present)
  time frame: Baseline (Day -27 to Day 1), Day 85 to Day 113
  description: To calculate the 'Change from Baseline', the herpes lesion rate during the timeframe of Day 85 to Day 113 will be compared against the herpes lesion rate during the timeframe of Day -27 to Day 1 (Baseline).
  measure: Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in Genital Herpes Lesion Rate (Proportion of Days With Lesions Present)
  time frame: Baseline (Day -27 to Day 1), Day 197 to Day 225
  description: To calculate the 'Change from Baseline', the herpes lesion rate during the timeframe of Day 197 to Day 225 will be compared against the herpes lesion rate during the timeframe of Day -27 to Day 1 (Baseline).
  measure: Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Proportion of HSV-2 Deoxyribonucleic acid [DNA] Positive Anogenital Swabs)
  time frame: Baseline (Day -27 to Day 1), Day 85 to Day 113
  description: To calculate the 'Change from Baseline', the HSV-2 genital shedding rate during the timeframe of Day 85 to Day 113 will be compared against the HSV-2 genital shedding rate during the timeframe of Day -27 to Day 1 (Baseline).
  measure: Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Proportion of HSV-2 DNA Positive Anogenital Swabs)
  time frame: Baseline (Day -27 to Day 1), Day 197 to Day 225
  description: To calculate the 'Change from Baseline', the HSV-2 genital shedding rate during the timeframe of Day 197 to Day 225 will be compared against the HSV-2 genital shedding rate during the timeframe of Day -27 to Day 1 (Baseline).
  measure: Geometric Mean Titer (GMT) of mRNA-1608 Antigen-Specific Binding Antibodies (bAbs) at 1 and 6 Months After the Second Study Injection
  time frame: Days 85 and 225
  measure: Geometric Mean Fold Rise (GMFR) of mRNA-1608 Antigen-Specific bAbs From Baseline to 1 and 6 Months After the Second Study Injection
  time frame: Baseline (Day 1), Days 85 and 225
  measure: Number of Participants With Vaccine Seroresponse
  time frame: Baseline (Day 1), Days 85 and 225
  description: Seroresponse is defined by an increase in HSV-2 bAb levels at Day 85 and Day 225 ≥4-fold if baseline level is above the lower level of quantitation (LLOQ) or ≥4 × LLOQ if baseline bAb level is <LLOQ prior to study injection.
  arm group label: mRNA-1608 Dose A
  arm group type: Experimental
  description: Participants will receive 2 intramuscular (IM) injections of mRNA-1608 at Dose Level A, each dose administered at 0 and 2 months (Day 1 and Day 57).
  arm group label: mRNA-1608 Dose B
  arm group type: Experimental
  description: Participants will receive 2 IM injections of mRNA-1608 at Dose Level B, each dose administered at 0 and 2 months (Day 1 and Day 57).
  arm group label: mRNA-1608 Dose C
  arm group type: Experimental
  description: Participants will receive 2 IM injections of mRNA-1608 at Dose Level C, each dose administered at 0 and 2 months (Day 1 and Day 57).
  arm group label: BEXSERO
  arm group type: Other
  description: Participants will receive 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57).
  intervention type: Biological
  intervention name: mRNA-1608
  description: Sterile liquid for injection
  arm group label: mRNA-1608 Dose A
  arm group label: mRNA-1608 Dose B
  arm group label: mRNA-1608 Dose C
  intervention type: Biological
  intervention name: BEXSERO
  description: A vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B.
  arm group label: BEXSERO
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Moderna Clinical Trials Support Center
  phone: 1-877-777-7187
  email: clinicaltrials@modernatx.com
  facility: 
  status: Not yet recruiting
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  status: Recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Herpes Simplex
  mesh term: Herpes Genitalis