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/NCT05972733</url>
    </required_header>
    <id_info>
      <org_study_id>NOR-215</org_study_id>
      <nct_id>NCT05972733</nct_id>
    </id_info>
    <brief_title>Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults</brief_title>
    <official_title>Phase 2, Single-arm, Open-label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular HIL-214 Norovirus Vaccine in Adults Aged 18 to 49 Years</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>HilleVax</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>HilleVax</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <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 trial is to obtain serum for proficiency testing to confirm assay&#xD;
        validity is maintained following the dosing of adults with a pediatric dose of HIL-214.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This single-arm trial serves to obtain serum for proficiency testing to confirm assay&#xD;
        validity is maintained. Exploratory aspects of this trial include evaluating additional&#xD;
        assays used for the assessment of immune responses to HIL-214 in peripheral-blood samples.&#xD;
        Given the large volume of blood required, the pediatric dose will be tested in healthy&#xD;
        adults. The main scientific rationale for the trial is to identify immune assays that can&#xD;
        assess the generation of serum antibodies or cell-mediated immunity (CMI) specific to&#xD;
        norovirus strains not represented in the HIL-214 vaccine (i.e. cross-reactivity).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">November 22, 2023</completion_date>
    <primary_completion_date type="Actual">August 14, 2023</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single-arm, Open-label Trial</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Immunogenicity for Panel Formation</measure>
      <time_frame>6 months</time_frame>
      <description>For the 80 subjects enrolled in the trial, the serum samples that will be collected will be used to produce a proficient assay panel based on immunogenicity results of the initial testing. This panel that is formed will be used for further analysis in other clinical trials.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Gastroenteritis</condition>
    <arm_group>
      <arm_group_label>Open Arm Study</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One dose given to all participants</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>HIL-214</intervention_name>
      <description>HIL-214</description>
      <arm_group_label>Open Arm Study</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female subjects aged 18 to 49 years, inclusive.&#xD;
  &#xD;
            -  Individuals who are in good health at the time of entry into the trial as determined&#xD;
               by medical history, physical examination (including vital signs) and clinical judgment&#xD;
               of the investigator.&#xD;
  &#xD;
            -  The individual signs and dates a written, informed consent form and any required&#xD;
               privacy authorization prior to the initiation of any trial procedures, after the&#xD;
               nature of the trial has been explained according to regulatory requirements.&#xD;
  &#xD;
            -  Individuals willing and able to comply with trial procedures and are available for the&#xD;
               duration of follow-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Females who are pregnant or breastfeeding.&#xD;
  &#xD;
            -  Gastroenteritis within 14 days before planned dosing (can warrant delay of trial&#xD;
               vaccine administration).&#xD;
  &#xD;
            -  Known hypersensitivity or allergy to any of the HIL-214 components (including&#xD;
               excipients).&#xD;
  &#xD;
            -  Known or suspected impairment/alteration of immune function, including history of any&#xD;
               autoimmune disease or neuro-inflammatory disease.&#xD;
  &#xD;
            -  Any serious chronic or progressive disease (including hepatitis B or C).&#xD;
  &#xD;
            -  Previous exposure to an experimental norovirus vaccine.&#xD;
  &#xD;
            -  Subject or subject's first-degree relatives are involved in the trial conduct.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>49 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Pennisula Research Associates</name>
        <address>
          <city>Rolling Hills Estates</city>
          <state>California</state>
          <zip>90274</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Clinical Research Atlanta</name>
        <address>
          <city>Stockbridge</city>
          <state>Georgia</state>
          <zip>30281</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastroenteritis</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/NCT05972733
  org study id: NOR-215
  nct id: NCT05972733
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this trial is to obtain serum for proficiency testing to confirm assay
        validity is maintained following the dosing of adults with a pediatric dose of HIL-214.
  This single-arm trial serves to obtain serum for proficiency testing to confirm assay
        validity is maintained. Exploratory aspects of this trial include evaluating additional
        assays used for the assessment of immune responses to HIL-214 in peripheral-blood samples.
        Given the large volume of blood required, the pediatric dose will be tested in healthy
        adults. The main scientific rationale for the trial is to identify immune assays that can
        assess the generation of serum antibodies or cell-mediated immunity (CMI) specific to
        norovirus strains not represented in the HIL-214 vaccine (i.e. cross-reactivity).
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single-arm, Open-label Trial
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Primary Immunogenicity for Panel Formation
  time frame: 6 months
  description: For the 80 subjects enrolled in the trial, the serum samples that will be collected will be used to produce a proficient assay panel based on immunogenicity results of the initial testing. This panel that is formed will be used for further analysis in other clinical trials.
  arm group label: Open Arm Study
  arm group type: Experimental
  description: One dose given to all participants
  intervention type: Biological
  intervention name: HIL-214
  description: HIL-214
  arm group label: Open Arm Study
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 49 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Gastroenteritis