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/NCT06002503</url>
    </required_header>
    <id_info>
      <org_study_id>VEEV-PJ-01</org_study_id>
      <nct_id>NCT06002503</nct_id>
    </id_info>
    <brief_title>Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection</brief_title>
    <official_title>A Phase I, Randomized, Observer-Blind Trial to Assess the Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis (VEE) DNA Vaccine Candidate Administered Intramuscularly and Intradermally by Jet Injection to Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>PharmaJet, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>PharmaJet, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to evaluate the safety and reactogenicity of a VEE DNA&#xD;
        Vaccine candidate delivered by either intramuscular or intradermal jet injection. The main&#xD;
        question it aims to answer is:&#xD;
  &#xD;
        • Is the VEE DNA Vaccine candidate safe&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet&#xD;
             injection&#xD;
  &#xD;
          -  Provide blood and urine samples&#xD;
  &#xD;
          -  Complete ECGs&#xD;
  &#xD;
          -  Complete physical exams&#xD;
  &#xD;
          -  Complete diaries&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 29, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2025</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>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with immediate reactions</measure>
      <time_frame>30 minutes after each vaccination</time_frame>
      <description>The nature, frequency, and severity of immediate reactions following vaccination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Solicited adverse events</measure>
      <time_frame>7 days after each vaccination</time_frame>
      <description>The nature, frequency, and severity of solicited adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Unsolicited adverse events</measure>
      <time_frame>28 days after the final vaccination</time_frame>
      <description>The nature, frequency, and severity of unsolicited adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse events</measure>
      <time_frame>1 year</time_frame>
      <description>The nature, frequency, and severity of adverse events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>VEEV-specific antibody</measure>
      <time_frame>1 year</time_frame>
      <description>PsVNA50</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Seroconversion rate</measure>
      <time_frame>1 year</time_frame>
      <description>PsVNA50</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Vaccine Reaction</condition>
    <arm_group>
      <arm_group_label>1: Intramuscular</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26</description>
    </arm_group>
    <arm_group>
      <arm_group_label>2: Intramuscular</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3: Intradermal</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26</description>
    </arm_group>
    <arm_group>
      <arm_group_label>4: Intradermal</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Venezuelan Equine Encephalitis DNA Vaccine</intervention_name>
      <description>Venezuelan Equine Encephalitis DNA Vaccine Candidate</description>
      <arm_group_label>1: Intramuscular</arm_group_label>
      <arm_group_label>2: Intramuscular</arm_group_label>
      <arm_group_label>3: Intradermal</arm_group_label>
      <arm_group_label>4: Intradermal</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PharmaJet Stratis Needle-free Injection System</intervention_name>
      <description>Intramuscular Needle-free Injection System (Jet Injector)</description>
      <arm_group_label>1: Intramuscular</arm_group_label>
      <arm_group_label>2: Intramuscular</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PharmaJet Tropis Needle-free Injection System</intervention_name>
      <description>Intradermal Needle-free Injection System (Jet Injector)</description>
      <arm_group_label>3: Intradermal</arm_group_label>
      <arm_group_label>4: Intradermal</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy adults, male or female.&#xD;
  &#xD;
            -  Ages at least 18 at the start of the study and no greater than 49 years of age on Day&#xD;
               1 of vaccination.&#xD;
  &#xD;
            -  Participants must be available for all visits and for the complete duration of the&#xD;
               study.&#xD;
  &#xD;
            -  Participants must, in the opinion of the Investigator or person obtaining consent,&#xD;
               understand the information provided and be capable of providing informed consent.&#xD;
  &#xD;
            -  Women of child bearing potential (WOCBP) must have a negative pregnancy test and be&#xD;
               willing to use an effective method of contraception: oral contraception, diaphragm,&#xD;
               cervical cap, intrauterine device, condom, or be anatomically sterile (in self or&#xD;
               partner) from the date of screening until at least 6 months after the last&#xD;
               vaccination.&#xD;
  &#xD;
            -  If subject is a sexually active male, must be willing to use an effective method of&#xD;
               contraception (such as condoms or be anatomically sterile) from screening until 6&#xD;
               months after the last vaccination.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Clinically relevant abnormality on history or examination including a history of&#xD;
               immunodeficiency or use of systemic corticosteroids, immunosuppressive, anticancer, or&#xD;
               other medications considered to be significant by the designated trial physician in&#xD;
               the last 6 months.&#xD;
  &#xD;
            -  Any acute or chronic medical condition requiring care of a physician (e.g., diabetes,&#xD;
               coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in&#xD;
               the opinion of the Investigator, would preclude participation.&#xD;
  &#xD;
            -  Any of the following laboratory parameters with abnormal values that are moderate in&#xD;
               severity: hematology (hemoglobin, absolute neutrophil count, absolute lymphocyte&#xD;
               count, platelets); urinalysis; biochemistries (total bilirubin, creatinine, AST, ALT).&#xD;
  &#xD;
            -  If female, pregnant, lactating, or planning pregnancy within 6 months of the final&#xD;
               vaccination.&#xD;
  &#xD;
            -  Receipt of a blood transfusion or blood products 6 months prior to enrollment.&#xD;
  &#xD;
            -  Participation in another clinical trial of an investigational product currently or&#xD;
               within the past 12 weeks or expected participation during the study.&#xD;
  &#xD;
            -  History of severe local or systemic reactions to vaccination or a history of severe&#xD;
               allergic reactions.&#xD;
  &#xD;
            -  History of Guillain-Barre syndrome.&#xD;
  &#xD;
            -  Confirmed diagnosis of HBV infection (surface antigen positive, HBsAg); Hepatitis C&#xD;
               infection (HCV Ab positive); HIV infection, or active syphilis.&#xD;
  &#xD;
            -  History of grand mal epilepsy, or currently taking anti-epileptics.&#xD;
  &#xD;
            -  Any condition associated with prolonged bleeding time, which would contraindicate skin&#xD;
               or muscle injection.&#xD;
  &#xD;
            -  Abnormal ECG finding that, in the opinion of the Investigator, excludes the subject&#xD;
               from participating.&#xD;
  &#xD;
            -  History of syncope or history of a fainting episode within one year of study entry.&#xD;
  &#xD;
            -  Extensive tattoos or markings covering the eligible sites of administration (the skin&#xD;
               or muscle of the upper left and right deltoid muscles).&#xD;
  &#xD;
            -  Presence of any surgical/traumatic metal implants, or significant scar tissue that may&#xD;
               impair appropriate injection at the eligible sites of administration (skin or muscle&#xD;
               of the upper left and right deltoid muscles).&#xD;
  &#xD;
            -  In the opinion of the Investigator, is unlikely to comply with the protocol.&#xD;
  &#xD;
            -  As confirmed/reported by the study subject, a history of: exposure to Venezuelan&#xD;
               Equine Encephalitis Virus (VEEV) or related alphavirus; prior immunization with an&#xD;
               alphavirus replicon-based vaccine; prior immunization with a live-attenuated&#xD;
               alphavirus vaccine; prior immunization with an inactivated alphavirus vaccine.&#xD;
  &#xD;
            -  A history of encephalitis as confirmed/reported by the study subject.&#xD;
  &#xD;
            -  Prior immunization against VEEV or related alphavirus or encephalitis, as&#xD;
               confirmed/reported by the study subject.&#xD;
  &#xD;
            -  History of alcohol abuse, illicit drug use, physical dependence on any opioid, or any&#xD;
               history of drug abuse (excluding marijuana) or addiction within 12 months of&#xD;
               screening.&#xD;
  &#xD;
            -  Involved in the planning or conduct of the study.&#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>Velocity Clinical Research</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45246</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Matthew Wenker, MD</last_name>
        <phone>513-671-8080</phone>
        <email>info@velocityclinical.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Encephalomyelitis, Equine</mesh_term>
      <mesh_term>Encephalomyelitis, Venezuelan Equine</mesh_term>
      <mesh_term>Encephalitis</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/NCT06002503
  org study id: VEEV-PJ-01
  nct id: NCT06002503
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: Yes
  The goal of this clinical trial is to evaluate the safety and reactogenicity of a VEE DNA
        Vaccine candidate delivered by either intramuscular or intradermal jet injection. The main
        question it aims to answer is:
  
        • Is the VEE DNA Vaccine candidate safe
  
        Participants will:
  
          -  Receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet
             injection
  
          -  Provide blood and urine samples
  
          -  Complete ECGs
  
          -  Complete physical exams
  
          -  Complete diaries
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  measure: Number of participants with immediate reactions
  time frame: 30 minutes after each vaccination
  description: The nature, frequency, and severity of immediate reactions following vaccination
  measure: Solicited adverse events
  time frame: 7 days after each vaccination
  description: The nature, frequency, and severity of solicited adverse events
  measure: Unsolicited adverse events
  time frame: 28 days after the final vaccination
  description: The nature, frequency, and severity of unsolicited adverse events
  measure: Adverse events
  time frame: 1 year
  description: The nature, frequency, and severity of adverse events
  measure: VEEV-specific antibody
  time frame: 1 year
  description: PsVNA50
  measure: Seroconversion rate
  time frame: 1 year
  description: PsVNA50
  arm group label: 1: Intramuscular
  arm group type: Experimental
  description: Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26
  arm group label: 2: Intramuscular
  arm group type: Experimental
  description: Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4
  arm group label: 3: Intradermal
  arm group type: Experimental
  description: Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26
  arm group label: 4: Intradermal
  arm group type: Experimental
  description: Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4
  intervention type: Drug
  intervention name: Venezuelan Equine Encephalitis DNA Vaccine
  description: Venezuelan Equine Encephalitis DNA Vaccine Candidate
  arm group label: 1: Intramuscular
  arm group label: 2: Intramuscular
  arm group label: 3: Intradermal
  arm group label: 4: Intradermal
  intervention type: Device
  intervention name: PharmaJet Stratis Needle-free Injection System
  description: Intramuscular Needle-free Injection System (Jet Injector)
  arm group label: 1: Intramuscular
  arm group label: 2: Intramuscular
  intervention type: Device
  intervention name: PharmaJet Tropis Needle-free Injection System
  description: Intradermal Needle-free Injection System (Jet Injector)
  arm group label: 3: Intradermal
  arm group label: 4: Intradermal
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 49 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Encephalomyelitis, Equine
  mesh term: Encephalomyelitis, Venezuelan Equine
  mesh term: Encephalitis