<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/NCT04439695</url>
  </required_header>
  <id_info>
    <org_study_id>KBP-101</org_study_id>
    <nct_id>NCT04439695</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults</brief_title>
  <official_title>A Phase 1, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KBio Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KBio Inc</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is an observer-blinded, randomized, placebo-controlled, parallel group study to evaluate&#xD;
      safety and immunogenicity of TAP-V001 quadrivalent influenza vaccine in healthy adult&#xD;
      subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be screened up to 14 days (Day -14 to Day 0) before randomization.&#xD;
&#xD;
      On the planned day of vaccination (Day 1), subjects will be randomized in a 1:1:1:1 ratio (N&#xD;
      = 30 subjects/group) to receive study vaccine or placebo by intramuscular (IM) injection.&#xD;
&#xD;
      Approximately 5 subjects per group (N = 20) will be enrolled in parallel initially, and&#xD;
      safety data through Day 8 will be collected. An Independent Data Monitoring Committee (IDMC)&#xD;
      will convene to review Day 8 safety data before any additional subjects will be enrolled. If&#xD;
      there are no safety concerns in the IDMC meeting, study enrollment will continue.&#xD;
&#xD;
      Blood and serum samples for safety laboratory tests and HAI titers will be obtained at&#xD;
      baseline on Day 1 before administration of vaccine dose and after vaccination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">July 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 25, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Solicited administration site reactions</measure>
    <time_frame>7 days after vaccination</time_frame>
    <description>Occurrences of Adverse Events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Solicited systemic events</measure>
    <time_frame>7 days after vaccination</time_frame>
    <description>Occurrences of Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Unsolicited Adverse Events</measure>
    <time_frame>43 days after vaccination</time_frame>
    <description>Safety Endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Serious Adverse Events and Medically Attended Events</measure>
    <time_frame>181 days after vaccination</time_frame>
    <description>Safety Endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccine HAI antibody Titers</measure>
    <time_frame>Day 1, 29, 43, 181</time_frame>
    <description>Vaccine HAI antibody Titers for each treatment group</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Low Dose KBP-V001</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive the low dose of KBP-V001.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermediate KBP-V001</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive the intermediate dose of KBP-V001.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose KBP-V001</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive the high dose of KBP-V001.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in this group will receive placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low dose</intervention_name>
    <description>Low dose of KBP-V001</description>
    <arm_group_label>Low Dose KBP-V001</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Intermediate dose</intervention_name>
    <description>Intermediate dose of KBP-V001</description>
    <arm_group_label>Intermediate KBP-V001</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High dose</intervention_name>
    <description>High dose of KBP-V001</description>
    <arm_group_label>High Dose KBP-V001</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Buffered Saline Solution</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Have read, understood, and signed the informed consent form (ICF)&#xD;
&#xD;
          2. Healthy adult males and females ages 18 to 49 years, inclusive at screening&#xD;
&#xD;
          3. Body mass index (BMI) of ≥18 and ≤34 kg/m2 at screening&#xD;
&#xD;
          4. Must be in general good health before study participation with no clinically relevant&#xD;
             abnormalities that could interfere with study assessments&#xD;
&#xD;
          5. Women of childbearing potential (WOCBP) and men whose sexual partners are WOCBP must&#xD;
             be able and willing to use at least 1 highly effective method of contraception during&#xD;
             the study and for 3 months after the study completion. A female subject is considered&#xD;
             to be a WOCBP after menarche and until she is in a postmenopausal state for 12&#xD;
             consecutive months (without an alternative medical cause) or otherwise permanently&#xD;
             sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy,&#xD;
             and bilateral oophorectomy).&#xD;
&#xD;
          6. Female subjects of childbearing potential must have a negative urine pregnancy test&#xD;
             before vaccination&#xD;
&#xD;
          7. Must be able to attend all visits for the duration of the study and comply with all&#xD;
             study procedures, including completion of Diary Card according to the study schedule.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. History of an acute or chronic medical condition that, in the opinion of the&#xD;
             investigator, would render vaccination unsafe or would interfere with the evaluation&#xD;
             of responses.&#xD;
&#xD;
          2. History of ongoing clinical condition or medication or treatments that may adversely&#xD;
             affect the immune system.&#xD;
&#xD;
          3. Individuals with any elevated (Grade 2 or higher) laboratory test assessed as&#xD;
             clinically significant by investigator at screening&#xD;
&#xD;
          4. Individuals with any elevated (Grade 2 or higher) liver function enzyme at screening,&#xD;
             regardless of the appraisal of clinical significance (cannot be retested to qualify&#xD;
             for study). See below the criteria for excluding subjects with elevated liver enzymes:&#xD;
&#xD;
               -  Alanine aminotransferase (ALT)/aspartate aminotransferase (AST): &gt;3 × upper limit&#xD;
                  of normal (ULN)&#xD;
&#xD;
               -  Total bilirubin: &gt;2 × ULN&#xD;
&#xD;
               -  Alkaline phosphatase (ALP)/gamma-glutamyl transferase (GGT): &gt;2.5 × ULN&#xD;
&#xD;
          5. Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully&#xD;
             treated) or a history of any hematological malignancy. For this criterion, &quot;active&quot; is&#xD;
             defined as having received treatment within the past 5 years.&#xD;
&#xD;
          6. Long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose&#xD;
             inhaled steroids (&gt;800 μg/day of beclomethasone dipropionate or equivalent) within 6&#xD;
             months before screening (nasal and topical steroids are allowed)&#xD;
&#xD;
          7. History of autoimmune or inflammatory disease&#xD;
&#xD;
          8. Women currently pregnant, nursing, or planning a pregnancy between enrollment and 181&#xD;
             days after randomization&#xD;
&#xD;
          9. History of a previous serious adverse reaction to any influenza vaccine&#xD;
&#xD;
         10. History of Guillain-Barré Syndrome&#xD;
&#xD;
         11. History of anaphylactic-type reaction to injected vaccines&#xD;
&#xD;
         12. Known or suspected hypersensitivity to 1 or more of the components of TAP-V001&#xD;
&#xD;
         13. History of illicit drug use or alcohol abuse in the year before screening&#xD;
&#xD;
         14. Receipt of any influenza vaccine within 6 months before screening&#xD;
&#xD;
         15. Receipt of any vaccine within 1 month before screening&#xD;
&#xD;
         16. Acute illness or fever within 3 days before study enrollment (enrollment may be&#xD;
             delayed for full recovery if acceptable to the investigator)&#xD;
&#xD;
         17. Individuals currently participating or planning to participate in a study that&#xD;
             involves an experimental agent (vaccine, drug, biologic, device, or medication); or&#xD;
             who have received an experimental agent within 1 month before enrollment in this&#xD;
             study; or who expect to receive another experimental agent during participation in&#xD;
             this study; or who intend to donate blood during the study period.&#xD;
&#xD;
         18. Receipt of immunoglobulin or another blood product within the 3 months before&#xD;
             enrollment in this study or those who expect to receive immunoglobulin or another&#xD;
             blood product during this study.&#xD;
&#xD;
         19. Individuals who plan to receive another vaccine, including seasonal influenza vaccine,&#xD;
             during the entire 6-month study period.&#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>
  <overall_official>
    <last_name>Hugh Haydon</last_name>
    <role>Study Director</role>
    <affiliation>Kentucky BioProcessing</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brandon Essink, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meridian Clinical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Vaccine</keyword>
  <keyword>Influenza Vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Plan is to share study data by dosing group in publications</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04439695
org study id: KBP-101
nct id: NCT04439695
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is an observer-blinded, randomized, placebo-controlled, parallel group study to evaluate
      safety and immunogenicity of TAP-V001 quadrivalent influenza vaccine in healthy adult
      subjects.
Subjects will be screened up to 14 days (Day -14 to Day 0) before randomization.

      On the planned day of vaccination (Day 1), subjects will be randomized in a 1:1:1:1 ratio (N
      = 30 subjects/group) to receive study vaccine or placebo by intramuscular (IM) injection.

      Approximately 5 subjects per group (N = 20) will be enrolled in parallel initially, and
      safety data through Day 8 will be collected. An Independent Data Monitoring Committee (IDMC)
      will convene to review Day 8 safety data before any additional subjects will be enrolled. If
      there are no safety concerns in the IDMC meeting, study enrollment will continue.

      Blood and serum samples for safety laboratory tests and HAI titers will be obtained at
      baseline on Day 1 before administration of vaccine dose and after vaccination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Solicited administration site reactions
time frame: 7 days after vaccination
description: Occurrences of Adverse Events
measure: Solicited systemic events
time frame: 7 days after vaccination
description: Occurrences of Adverse Events
measure: Number of Unsolicited Adverse Events
time frame: 43 days after vaccination
description: Safety Endpoint
measure: Number of Serious Adverse Events and Medically Attended Events
time frame: 181 days after vaccination
description: Safety Endpoint
measure: Vaccine HAI antibody Titers
time frame: Day 1, 29, 43, 181
description: Vaccine HAI antibody Titers for each treatment group
arm group label: Low Dose KBP-V001
arm group type: Experimental
description: Subjects in this group will receive the low dose of KBP-V001.
arm group label: Intermediate KBP-V001
arm group type: Experimental
description: Subjects in this group will receive the intermediate dose of KBP-V001.
arm group label: High Dose KBP-V001
arm group type: Experimental
description: Subjects in this group will receive the high dose of KBP-V001.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects in this group will receive placebo
intervention type: Biological
intervention name: Low dose
description: Low dose of KBP-V001
arm group label: Low Dose KBP-V001
intervention type: Biological
intervention name: Intermediate dose
description: Intermediate dose of KBP-V001
arm group label: Intermediate KBP-V001
intervention type: Biological
intervention name: High dose
description: High dose of KBP-V001
arm group label: High Dose KBP-V001
intervention type: Biological
intervention name: Placebo
description: Buffered Saline Solution
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hugh Haydon
role: Study Director
affiliation: Kentucky BioProcessing
last name: Brandon Essink, MD
role: Principal Investigator
affiliation: Meridian Clinical Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No
ipd description: Plan is to share study data by dosing group in publications