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/NCT05989672</url>
    </required_header>
    <id_info>
      <org_study_id>218459</org_study_id>
      <nct_id>NCT05989672</nct_id>
    </id_info>
    <brief_title>A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years</brief_title>
    <acronym>TH HSV REC-004</acronym>
    <official_title>A Phase 1, Observer-blind, Randomized, Placebo-Controlled Study to Evaluate Reactogenicity, Safety and Immune Response of an HSV-targeted Immunotherapy in HSV-2 Seronegative Japanese Participants Aged 18-40 Years</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>GlaxoSmithKline</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>GlaxoSmithKline</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2&#xD;
        formulations of Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI) in HSV-2&#xD;
        seronegative ethnic Japanese adults aged 18-40 years.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">May 9, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 27, 2023</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>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Click here to enter text.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of participants with solicited administration site events</measure>
      <time_frame>Within 7 days post-study intervention administration (i.e., the day of intervention and 6 subsequent days, study intervention administered on Day 1 and Day 29)</time_frame>
      <description>Assessed solicited administration site events include redness, pain, and swelling.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants with solicited systemic events</measure>
      <time_frame>Within 7 days post-study intervention administration (i.e., the day of intervention and 6 subsequent days, study intervention administered on Day 1 and Day 29)</time_frame>
      <description>Assessed solicited systemic events included fever, myalgia, arthralgia, headache, and fatigue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants with unsolicited adverse events (AEs)</measure>
      <time_frame>Within 28 days post-study intervention administration (i.e., the day of intervention and 27 subsequent days, study intervention administered on Day 1 and Day 29)</time_frame>
      <description>An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting Medically Attended Events (MAEs)</measure>
      <time_frame>From Day 1 (dose 1) up to Day 57 (28 days post dose 2)</time_frame>
      <description>MAEs are defined as adverse events requiring medically-attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting Serious Adverse Events (SAEs)</measure>
      <time_frame>From Day 1 (dose 1) up to Day 57 (28 days post dose 2)</time_frame>
      <description>A SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting any newly diagnosed Potential Immune-Mediated Diseases (pIMDs)</measure>
      <time_frame>From Day 1 (dose 1) up to Day 57 (28 days post dose 2)</time_frame>
      <description>Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting any exacerbation of pre-existing pIMDs</measure>
      <time_frame>From Day 1 (dose 1) up to Day 57 (28 days post dose 2)</time_frame>
      <description>Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants reporting any hematological and biochemical laboratory abnormalities</measure>
      <time_frame>At Day 1 (pre-dose 1), Day 8 and Day 29 post-dose 1, and Day 36 and Day 57 post-dose 2</time_frame>
      <description>The hematological and biochemical laboratory abnormalities will be assessed using a toxicity grading scale (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=potentially life-threatening). The hematological and biochemical laboratory parameters considered for this analysis are: hemoglobin, white blood cells increase and decrease, platelets decrease, alanine aminotransferase, aspartate aminotransferase, creatinine and blood urea nitrogen.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anti-Herpes Simplex Virus Targeted Immunotherapy (HSVTI) antibody geometric mean concentration (GMC)</measure>
      <time_frame>At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)</time_frame>
      <description>Anti-HSVTI antibody GMC will be measured in titers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Seropositivity rate of anti-HSVTI antibody</measure>
      <time_frame>At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)</time_frame>
      <description>The seropositivity rate of anti-HSVTI antibody will be Enzyme-Linked Immunosorbent Assay (ELISA) assessed and measured in ELISA Units pe milliliter (EU/mL).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geometric mean of HSVTI-specific cluster of differentiation (CD)4+/CD8+ T cells frequency</measure>
      <time_frame>At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)</time_frame>
      <description>The geometric mean of HSVTI CD4+/CD8+ T cells frequency will be assessed to cells expressing at least 2 activation markers (Interferon [IFN]-gamma, Tumour necrosis factor [TNF]-alpha, Interleukin [IL]-2, IL-13, IL-17, 4-1BB and/or CD40L) and including at least one cytokine (assessed by cell glow cytometry [CFC]).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting MAEs</measure>
      <time_frame>From Day 1 (dose 1) up to Day 209 (end of study)</time_frame>
      <description>MAEs are defined as adverse events requiring medically-attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting SAEs</measure>
      <time_frame>From Day 1 (dose 1) up to Day 209 (end of study)</time_frame>
      <description>A SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting any newly diagnosed Potential Immune-Mediated Diseases (pIMDs)</measure>
      <time_frame>From Day 1 (dose 1) up to Day 209 (end of study)</time_frame>
      <description>Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants reporting any exacerbation of pre-existing pIMDs</measure>
      <time_frame>From Day 1 (dose 1) up to Day 209 (end of study)</time_frame>
      <description>Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Herpes Simplex</condition>
    <arm_group>
      <arm_group_label>HSVTI_F1 group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>HSV-2 seronegative participants randomized in this group will receive 2 doses of HSVTI Formulation 1 of the study intervention at Day 1 and Day 29.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HSVTI_F2 group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>HSV-2 seronegative participants randomized in this group will receive 2 doses of HSVTI Formulation 2 of the study intervention at Day 1 and Day 29.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>HSV-2 seronegative participants randomized in this group will receive 2 doses of placebo as control at Day 1 and Day 29.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>HSVTI Formulation 1</intervention_name>
      <description>This investigational intervention will be administered intramuscular as 2 doses to HSVTI_F1 Group.</description>
      <arm_group_label>HSVTI_F1 group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>HSVTI Formulation 2</intervention_name>
      <description>This investigational intervention will be administered intramuscular as 2 doses to HSVTI_F2 Group.</description>
      <arm_group_label>HSVTI_F2 group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>This intervention will be administered intramuscular as 2 doses to Placebo group.</description>
      <arm_group_label>Placebo group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • Participants who, in the opinion of the investigator, can and will comply with the&#xD;
          requirements of the protocol (e.g., completion of the diary cards, return for follow-up&#xD;
          visits).&#xD;
  &#xD;
            -  Written informed consent obtained from the participant prior to performance of any&#xD;
               study-specific procedure.&#xD;
  &#xD;
            -  Healthy participants as established by medical history and physical examination, at&#xD;
               the discretion of the investigator, before entering into the study.&#xD;
  &#xD;
            -  Man or woman aged 18 to 40 years, included, at the time of screening.&#xD;
  &#xD;
            -  Japanese ethnic origin (defined as having been born in Japan with 4 ethnic Japanese&#xD;
               grandparents and able to speak Japanese).&#xD;
  &#xD;
            -  Women of non-childbearing potential may be enrolled in the study.&#xD;
  &#xD;
            -  Women of childbearing potential may be enrolled in the study, if the participant:&#xD;
  &#xD;
                 -  Has practiced highly effective contraception for 1 month prior to study&#xD;
                    intervention administration, and&#xD;
  &#xD;
                 -  Has a negative pregnancy test result at the Screening visit and on the day of&#xD;
                    each study intervention administration, and&#xD;
  &#xD;
                 -  Has agreed to continue highly effective contraception until Day 118,&#xD;
                    approximately 3 months post-Dose 2.&#xD;
  &#xD;
          Blood sample for simultaneous FSH and estradiol levels may be collected and tested locally&#xD;
          at the discretion of the investigator to confirm non-reproductive potential according to&#xD;
          local laboratory reference range.&#xD;
  &#xD;
          • Seronegative for HSV-2 as determined by Western blot performed at the Screening visit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Medical conditions:&#xD;
  &#xD;
            -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine,&#xD;
               or renal functional abnormality, as determined by physical examination or laboratory&#xD;
               screening tests.&#xD;
  &#xD;
                 -  Clinically significant abnormalities may include but are not limited to: evidence&#xD;
                    of cardiac damage, heart failure categorized as class II or greater according to&#xD;
                    the New York Heart Association functional classification, heart valve disease,&#xD;
                    pulmonary uncontrolled persistent asthma despite treatment, uncontrolled&#xD;
                    diabetes, or disease or disorder that may put the participant at risk or&#xD;
                    influence study results.&#xD;
  &#xD;
                 -  Participants with a controlled underlying chronic co-morbidity may be enrolled,&#xD;
                    provided there have been no changes to their medication within 3 months prior to&#xD;
                    the Screening visit.&#xD;
  &#xD;
            -  Any other clinical condition that, in the opinion of the investigator, might pose&#xD;
               additional risk to the participant due to participation in the study or that would&#xD;
               interfere with the immunogenicity assessments planned in this study.&#xD;
  &#xD;
            -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
               of the study intervention.&#xD;
  &#xD;
            -  Any confirmed or suspected immunosuppressive or immunodeficient condition or&#xD;
               documented or suspected HIV infection, based on medical history and physical&#xD;
               examination (no laboratory testing required).&#xD;
  &#xD;
          Hypersensitivity to latex.&#xD;
  &#xD;
            -  Recurrent history of or uncontrolled neurological disorders or seizures.&#xD;
  &#xD;
            -  At the screening visit: hematological parameters (hemoglobin level, white blood cell,&#xD;
               platelet) and/or biochemical parameters (ALT, AST, creatinine, blood urea nitrogen)&#xD;
               outside the normal laboratory ranges, unless the laboratory abnormalities are&#xD;
               considered not clinically significant by the investigator.&#xD;
  &#xD;
            -  Body mass index =18 kg/m2 or =35 kg/m2.&#xD;
  &#xD;
            -  History of any form of ocular HSV infection, HSV-related erythema multiforme, or&#xD;
               HSV-related neurological complications (including meningitis, encephalitis,&#xD;
               radiculopathy, myelitis).&#xD;
  &#xD;
          Prior/Concomitant therapy:&#xD;
  &#xD;
            -  Use of any investigational or non-registered product (drug, vaccine or invasive&#xD;
               medical device) other than the study intervention during the period beginning as of&#xD;
               the Screening visit, or their planned use during the study period.&#xD;
  &#xD;
            -  Planned administration or administration of a vaccine* in the period starting 15 days*&#xD;
               before each dose and ending 15 days* after each dose of study intervention&#xD;
               administration**.&#xD;
  &#xD;
               * In case of adjuvanted and live-attenuated vaccines, this time window is to be&#xD;
               increased to 30 days before and after each dose.&#xD;
  &#xD;
                 -  In case emergency mass vaccination for an unforeseen public health threat (e.g.,&#xD;
                    a pandemic) is recommended and/or organized by public health authorities outside&#xD;
                    the routine immunization program, the time period described above can be reduced&#xD;
                    if, necessary for that vaccine, provided it is used according to the local&#xD;
                    governmental recommendations and that the Sponsor is notified accordingly.&#xD;
  &#xD;
            -  Administration or planned administration of long-acting immune-modifying drugs at any&#xD;
               time during the study period (e.g., infliximab).&#xD;
  &#xD;
            -  Administration of immunoglobulins and/or any blood products or plasma derivatives&#xD;
               during the period starting 3 months before the first dose of study intervention or&#xD;
               planned administration during the study period.&#xD;
  &#xD;
            -  Chronic administration (defined as more than 14 days in total) of immunosuppressants&#xD;
               or other immune-modifying drugs during the period starting 3 months prior to the first&#xD;
               study intervention dose. For corticosteroids, this will mean prednisone equivalent =20&#xD;
               mg/day for adult participants. Inhaled, intra articular and topical steroids are&#xD;
               allowed.&#xD;
  &#xD;
            -  Prior receipt of a vaccine containing HSV antigens.&#xD;
  &#xD;
          Prior/Concurrent clinical study experience:&#xD;
  &#xD;
          • Concurrently participating in another clinical study, at any time during the study&#xD;
          period, in which the participant has been or will be exposed to an investigational or a&#xD;
          non-investigational intervention (drug or invasive medical device).&#xD;
  &#xD;
          Other exclusions:&#xD;
  &#xD;
          • Pregnant or lactating woman. Woman planning to become pregnant or planning to discontinue&#xD;
          contraceptive precautions before Day 118 (approximately 3 months post-Dose 2).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>EU GSK Clinical Trials Call Center</last_name>
      <phone>+44 (0) 20 89904466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Tokyo</city>
          <zip>160-0017</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Herpes Simplex Virus genital herpes</keyword>
    <keyword>Herpes Simplex Virus</keyword>
    <keyword>Reactogenicity</keyword>
    <keyword>Safety</keyword>
    <keyword>Immune response</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Herpes Simplex</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.</ipd_time_frame>
      <ipd_access_criteria>Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.</ipd_access_criteria>
      <ipd_url>https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_url>
    </patient_data>
    <!-- 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/NCT05989672
  org study id: 218459
  nct id: NCT05989672
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2
        formulations of Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI) in HSV-2
        seronegative ethnic Japanese adults aged 18-40 years.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Click here to enter text.
  measure: Percentage of participants with solicited administration site events
  time frame: Within 7 days post-study intervention administration (i.e., the day of intervention and 6 subsequent days, study intervention administered on Day 1 and Day 29)
  description: Assessed solicited administration site events include redness, pain, and swelling.
  measure: Percentage of participants with solicited systemic events
  time frame: Within 7 days post-study intervention administration (i.e., the day of intervention and 6 subsequent days, study intervention administered on Day 1 and Day 29)
  description: Assessed solicited systemic events included fever, myalgia, arthralgia, headache, and fatigue.
  measure: Percentage of participants with unsolicited adverse events (AEs)
  time frame: Within 28 days post-study intervention administration (i.e., the day of intervention and 27 subsequent days, study intervention administered on Day 1 and Day 29)
  description: An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.
  measure: Percentage of participants reporting Medically Attended Events (MAEs)
  time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
  description: MAEs are defined as adverse events requiring medically-attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
  measure: Percentage of participants reporting Serious Adverse Events (SAEs)
  time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
  description: A SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
  measure: Percentage of participants reporting any newly diagnosed Potential Immune-Mediated Diseases (pIMDs)
  time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
  description: Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.
  measure: Percentage of participants reporting any exacerbation of pre-existing pIMDs
  time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
  description: Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.
  measure: Percentage of participants reporting any hematological and biochemical laboratory abnormalities
  time frame: At Day 1 (pre-dose 1), Day 8 and Day 29 post-dose 1, and Day 36 and Day 57 post-dose 2
  description: The hematological and biochemical laboratory abnormalities will be assessed using a toxicity grading scale (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=potentially life-threatening). The hematological and biochemical laboratory parameters considered for this analysis are: hemoglobin, white blood cells increase and decrease, platelets decrease, alanine aminotransferase, aspartate aminotransferase, creatinine and blood urea nitrogen.
  measure: Anti-Herpes Simplex Virus Targeted Immunotherapy (HSVTI) antibody geometric mean concentration (GMC)
  time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
  description: Anti-HSVTI antibody GMC will be measured in titers.
  measure: Seropositivity rate of anti-HSVTI antibody
  time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
  description: The seropositivity rate of anti-HSVTI antibody will be Enzyme-Linked Immunosorbent Assay (ELISA) assessed and measured in ELISA Units pe milliliter (EU/mL).
  measure: Geometric mean of HSVTI-specific cluster of differentiation (CD)4+/CD8+ T cells frequency
  time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
  description: The geometric mean of HSVTI CD4+/CD8+ T cells frequency will be assessed to cells expressing at least 2 activation markers (Interferon [IFN]-gamma, Tumour necrosis factor [TNF]-alpha, Interleukin [IL]-2, IL-13, IL-17, 4-1BB and/or CD40L) and including at least one cytokine (assessed by cell glow cytometry [CFC]).
  measure: Percentage of participants reporting MAEs
  time frame: From Day 1 (dose 1) up to Day 209 (end of study)
  description: MAEs are defined as adverse events requiring medically-attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
  measure: Percentage of participants reporting SAEs
  time frame: From Day 1 (dose 1) up to Day 209 (end of study)
  description: A SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
  measure: Percentage of participants reporting any newly diagnosed Potential Immune-Mediated Diseases (pIMDs)
  time frame: From Day 1 (dose 1) up to Day 209 (end of study)
  description: Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.
  measure: Percentage of participants reporting any exacerbation of pre-existing pIMDs
  time frame: From Day 1 (dose 1) up to Day 209 (end of study)
  description: Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.
  arm group label: HSVTI_F1 group
  arm group type: Experimental
  description: HSV-2 seronegative participants randomized in this group will receive 2 doses of HSVTI Formulation 1 of the study intervention at Day 1 and Day 29.
  arm group label: HSVTI_F2 group
  arm group type: Experimental
  description: HSV-2 seronegative participants randomized in this group will receive 2 doses of HSVTI Formulation 2 of the study intervention at Day 1 and Day 29.
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: HSV-2 seronegative participants randomized in this group will receive 2 doses of placebo as control at Day 1 and Day 29.
  intervention type: Biological
  intervention name: HSVTI Formulation 1
  description: This investigational intervention will be administered intramuscular as 2 doses to HSVTI_F1 Group.
  arm group label: HSVTI_F1 group
  intervention type: Biological
  intervention name: HSVTI Formulation 2
  description: This investigational intervention will be administered intramuscular as 2 doses to HSVTI_F2 Group.
  arm group label: HSVTI_F2 group
  intervention type: Biological
  intervention name: Placebo
  description: This intervention will be administered intramuscular as 2 doses to Placebo group.
  arm group label: Placebo group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: US GSK Clinical Trials Call Center
  phone: 877-379-3718
  email: GSKClinicalSupportHD@gsk.com
  last name: EU GSK Clinical Trials Call Center
  phone: +44 (0) 20 89904466
  email: GSKClinicalSupportHD@gsk.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Japan
  responsible party type: Sponsor
  mesh term: Herpes Simplex
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
  ipd access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
  ipd url: https://www.gsk.com/en-gb/innovation/trials/data-transparency/