<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/NCT04473690</url>
  </required_header>
  <id_info>
    <org_study_id>KBP-201</org_study_id>
    <nct_id>NCT04473690</nct_id>
  </id_info>
  <brief_title>KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers</brief_title>
  <official_title>A Phase I/II, First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of TAP-COVID-19 SARS-CoV-2 Vaccine With CpG Adjuvant in Healthy Adults Aged 18-49 and 50-85</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 First In Human (FIH), observer-blinded, randomized, placebo-controlled, parallel&#xD;
      group study to evaluate the safety and immunogenicity of KBP-COVID-19 plus CPG adjuvant&#xD;
      vaccine in healthy adult subjects in 2 age groups, Part A (18-49 years) and Part B (50-85&#xD;
      years).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization.&#xD;
&#xD;
      Approximately 90 eligible healthy adults ages 18-49 years (inclusive) will be enrolled for&#xD;
      Part A and 90 eligible healthy seronegative adults ages 50-85 years will be enrolled for Part&#xD;
      B.&#xD;
&#xD;
      Sentinel dosing (three subjects in each group) will be utilized in this FIH study. Sentinel&#xD;
      cohorts will be used for the following groups:&#xD;
&#xD;
      Part A (18-49 years) low dose Part B (50-85 years) low dose Part A (18-49 years) high dose&#xD;
      Part B (50-85 years) high dose&#xD;
&#xD;
      Overall, subjects will be randomized in a 1:1:1 ratio to receive study vaccine or placebo by&#xD;
      IM injection on Days 1 and 22.&#xD;
&#xD;
      All study visits will be conducted at the clinical sites on an outpatient basis. Subjects&#xD;
      will participate in the study for approximately 1 year from the first dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2020</start_date>
  <completion_date type="Actual">October 14, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</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>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>Occurrence of Adverse Events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Solicited systemic events</measure>
    <time_frame>7 days after vaccination</time_frame>
    <description>Occurrence of Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unsolicited Adverse Events and medically attended adverse events</measure>
    <time_frame>43 days after vaccination</time_frame>
    <description>Safety Endpoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events, Medically Attended Adverse Events and New Onset Chronic Diseae</measure>
    <time_frame>365 days after vaccination</time_frame>
    <description>Safety Endpoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccine ELISA and neutralizing antibody titers for each treatment group</measure>
    <time_frame>Baseline, Day 8, 15, 22, 29, 43, 90, 181, 273, 365</time_frame>
    <description>Immunogenicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rates</measure>
    <time_frame>Days 8, 15, 22, 29, 43, 90, 181, 273, 365</time_frame>
    <description>Immunogenicity</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Low Dose KBP-COVID-19 and adjuvant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two age groups.&#xD;
Part A (18-49 years).&#xD;
Part B (50-85 years).&#xD;
All subjects in these groups will receive the low dose of KBP-COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose KBP-COVID-19 and adjuvant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two age groups.&#xD;
Part A (18-49 years).&#xD;
Part B (50-85 years).&#xD;
All subjects in these groups will receive the high dose of KBP-COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two age groups.&#xD;
Part A (18-49 years).&#xD;
Part B (50-85 years).&#xD;
All subjects in these groups will receive placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low Dose of KBP-COVID-19</intervention_name>
    <description>Low Dose of KBP-COVID-19 and adjuvant</description>
    <arm_group_label>Low Dose KBP-COVID-19 and adjuvant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High Dose of KBP-COVID-19</intervention_name>
    <description>High Dose of KBP-COVID-19 and adjuvant</description>
    <arm_group_label>High Dose KBP-COVID-19 and adjuvant</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. Subject read, understood, and signed the informed consent form (ICF).&#xD;
&#xD;
          2. Healthy adult males and females 18-49 years of age (Part A) or 50-85 years of age&#xD;
             (Part B), inclusive, at screening.&#xD;
&#xD;
          3. RT-PCR negative at time of screening.&#xD;
&#xD;
          4. Body mass index (BMI) of ≥ 18 and ≤ 30 kg/m2 at screening. BMI = weight (kg)/(height&#xD;
             [m])2.&#xD;
&#xD;
          5. Must be in general good health before study participation with no clinically relevant&#xD;
             abnormalities that could interfere with study assessments.&#xD;
&#xD;
          6. 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 (ie,&#xD;
             include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, hormonal&#xD;
             oral [in combination with male condoms with spermicide], transdermal, implant, or&#xD;
             injection, barrier [ie, condom, diaphragm with spermicide]; intrauterine device;&#xD;
             vasectomized partner [6 months minimum], clinically sterile partner; or abstinence)&#xD;
             during the study. A female subject is considered to be a WOCBP after menarche and&#xD;
             until she is in a postmenopausal state for 12 consecutive months (without an&#xD;
             alternative medical cause) or otherwise permanently sterile. Note: Subjects not of&#xD;
             childbearing potential are not required to use any other forms of contraception during&#xD;
             the study. Non-childbearing potential is defined as subject confirmed:&#xD;
&#xD;
               -  Surgical sterilization (eg, bilateral oophorectomy, bilateral salpingectomy,&#xD;
                  bilateral occlusion by cautery [Essure System is not acceptable], hysterectomy,&#xD;
                  or tubal ligation).&#xD;
&#xD;
               -  Postmenopausal (defined as permanent cessation of menstruation for at least 12&#xD;
                  consecutive months prior to screening) with FSH ≥ 30 mIU/mL at screening.&#xD;
&#xD;
          7. WOCBP must have a negative urine pregnancy test before each vaccination.&#xD;
&#xD;
          8. Must be able to attend all visits, including unscheduled visits if respiratory&#xD;
             symptoms develop during the study, for the duration of the study and comply with all&#xD;
             study procedures, including daily completion of the Diary Card for 7 days after each&#xD;
             injection.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. History of an acute or chronic medical condition including dementia that, in the&#xD;
             opinion of the Investigator, would render vaccination unsafe or would interfere with&#xD;
             the evaluation of responses. Chronic conditions that are NOT included on the Center&#xD;
             for Disease Control's list of subjects at higher risk for severe illness from&#xD;
             SARS-CoV-2 are acceptable if the condition has been stable for the 3 months prior to&#xD;
             vaccine administration (Day 1), with no medication changes, and no hospitalization in&#xD;
             the past 6 months.&#xD;
&#xD;
          2. History of any medical conditions that place subjects at higher risk for severe&#xD;
             illness due to SARS-CoV-2 including but not limited to cancer, chronic kidney disease&#xD;
             at any stage, chronic lung disease, dementia or other neurological conditions,&#xD;
             diabetes (Type 1 or Type 2), Down syndrome, heart conditions, human immunodeficiency&#xD;
             virus (HIV) infection, immunocompromised state (weakened immune system), liver&#xD;
             disease, overweight/obesity, pregnancy, sickle cell disease or thalassemia, smoker&#xD;
             (current or former), transplants (solid organ or blood stem cell), stroke or&#xD;
             cerebrovascular disease, and substance use disorders.&#xD;
&#xD;
          3. History of ongoing clinical condition or medication or treatments that may adversely&#xD;
             affect the immune system.&#xD;
&#xD;
          4. Individuals who are PCR positive for SARS-CoV-2 at screening or prior to second dose&#xD;
             of TAP-COVID-19 vaccine.&#xD;
&#xD;
          5. Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare&#xD;
             workers, emergency responders).&#xD;
&#xD;
          6. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to&#xD;
             vaccine administration.&#xD;
&#xD;
          7. Living in a group care facility (eg, assisted living or nursing home).&#xD;
&#xD;
          8. Individuals with any elevated (Grade 1 or higher) laboratory test assessed as&#xD;
             clinically significant for age by the Investigator at screening.&#xD;
&#xD;
          9. Individuals with any elevated (Grade 1 or higher) liver function enzyme at screening,&#xD;
&#xD;
         10. Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully&#xD;
             treated) or a history of any hematological malignancy. &quot;Active&quot; is defined as having&#xD;
             received treatment within the past 5 years.&#xD;
&#xD;
         11. Long-term (greater than 2 weeks) use of oral or parenteral steroids, high-dose inhaled&#xD;
             steroids (&gt;800 μg/day of beclomethasone dipropionate or equivalent), or&#xD;
             immunomodulatory drugs within 6 months before screening (nasal and topical steroids&#xD;
             are allowed).&#xD;
&#xD;
         12. History of autoimmune, inflammatory disease, or potential immune-mediated medical&#xD;
             conditions (Appendix B).&#xD;
&#xD;
         13. Women currently pregnant, lactating, or planning a pregnancy between enrollment and&#xD;
             181 days after randomization.&#xD;
&#xD;
         14. History of Guillain-Barré Syndrome.&#xD;
&#xD;
         15. History of anaphylactic-type reaction to injected vaccines.&#xD;
&#xD;
         16. Known or suspected hypersensitivity to 1 or more of the components of the vaccine,&#xD;
             including thimerosal, tobacco, and CpG adjuvant.&#xD;
&#xD;
         17. History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any&#xD;
             history of drug abuse or addiction within 12 months of screening.&#xD;
&#xD;
         18. 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;
         19. 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 (3 months for immunoglobulins)&#xD;
             before enrollment in this study; or who expect to receive another experimental agent&#xD;
             during participation in this study.&#xD;
&#xD;
         20. 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;
         21. Individuals who intend to donate blood within 6 months after the first vaccination.&#xD;
&#xD;
         22. Individuals using prescription medications for prophylaxis of SARS-CoV-2.&#xD;
&#xD;
         23. Individuals who plan to receive another vaccine within the first 3 months of the study&#xD;
             except influenza vaccine which should not be given within 2 weeks of study vaccine.&#xD;
&#xD;
         24. Receipt of any other approved SARS CoV 2 vaccine prior to the first study vaccine or&#xD;
             within 90 days after administration of the first study vaccine.&#xD;
&#xD;
         25. Receipt of any other experimental coronavirus vaccine at any time prior to or during&#xD;
             the study.&#xD;
&#xD;
         26. Receipt of any investigational vaccine or drug within 1 month of enrollment and&#xD;
             through the end of the study (1 year after first vaccination).&#xD;
&#xD;
         27. Plan to travel outside the subjects' country of residence from enrollment through Day&#xD;
             43.&#xD;
&#xD;
         28. History of surgery or major trauma within 12 weeks of screening, or surgery planned&#xD;
             during the study.&#xD;
&#xD;
         29. Significant blood loss (&gt;450 mL) or has donated 1 or more units of blood or plasma&#xD;
             within 6 weeks prior to study participation.&#xD;
&#xD;
         30. Strenuous activity (as assessed by the Investigator) within 48 hours prior to dosing&#xD;
             (Days 1 and 22).&#xD;
&#xD;
         31. A positive urine drug screen without evidence of corresponding prescribed concomitant&#xD;
             medication(s) at Screening.&#xD;
&#xD;
         32. Positive alcohol screen.&#xD;
&#xD;
         33. Positive screen for HIV-1 and HIV-2 antibodies, hepatitis B surface antigen (HBsAg),&#xD;
             or hepatitis C virus (HCV) antibody.&#xD;
&#xD;
         34. Involved in the planning or conduct of this study.&#xD;
&#xD;
         35. Unwilling or unlikely to comply with the requirements of the study.&#xD;
&#xD;
         36. Subject is an employee, contractor, friend of or relative of any employee of Sponsor,&#xD;
             contract research organization (CRO), study site or site affiliate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 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>
  <location>
    <facility>
      <name>Palm Beach Research Center</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velocity Clinical Research</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Winston-Salem</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PanAmerican Clinical Research</name>
      <address>
        <city>Brownsville</city>
        <state>Texas</state>
        <zip>78520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICON</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DM Clinical Research</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMC Manna Research</name>
      <address>
        <city>Burlington</city>
        <state>Burlington/Ontario</state>
        <zip>L7M 441</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMC Manna Research</name>
      <address>
        <city>Montréal</city>
        <state>Point Claire, Quebec</state>
        <zip>H9R 45B</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>November 11, 2022</last_update_submitted>
  <last_update_submitted_qc>November 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vaccine</keyword>
  <keyword>Covid19 Vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04473690
org study id: KBP-201
nct id: NCT04473690
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is an First In Human (FIH), observer-blinded, randomized, placebo-controlled, parallel
      group study to evaluate the safety and immunogenicity of KBP-COVID-19 plus CPG adjuvant
      vaccine in healthy adult subjects in 2 age groups, Part A (18-49 years) and Part B (50-85
      years).
Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization.

      Approximately 90 eligible healthy adults ages 18-49 years (inclusive) will be enrolled for
      Part A and 90 eligible healthy seronegative adults ages 50-85 years will be enrolled for Part
      B.

      Sentinel dosing (three subjects in each group) will be utilized in this FIH study. Sentinel
      cohorts will be used for the following groups:

      Part A (18-49 years) low dose Part B (50-85 years) low dose Part A (18-49 years) high dose
      Part B (50-85 years) high dose

      Overall, subjects will be randomized in a 1:1:1 ratio to receive study vaccine or placebo by
      IM injection on Days 1 and 22.

      All study visits will be conducted at the clinical sites on an outpatient basis. Subjects
      will participate in the study for approximately 1 year from the first dose.
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: Occurrence of Adverse Events
measure: Solicited systemic events
time frame: 7 days after vaccination
description: Occurrence of Adverse Events
measure: Unsolicited Adverse Events and medically attended adverse events
time frame: 43 days after vaccination
description: Safety Endpoints
measure: Serious Adverse Events, Medically Attended Adverse Events and New Onset Chronic Diseae
time frame: 365 days after vaccination
description: Safety Endpoints
measure: Vaccine ELISA and neutralizing antibody titers for each treatment group
time frame: Baseline, Day 8, 15, 22, 29, 43, 90, 181, 273, 365
description: Immunogenicity
measure: Seroconversion rates
time frame: Days 8, 15, 22, 29, 43, 90, 181, 273, 365
description: Immunogenicity
arm group label: Low Dose KBP-COVID-19 and adjuvant
arm group type: Experimental
description: Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the low dose of KBP-COVID-19
arm group label: High Dose KBP-COVID-19 and adjuvant
arm group type: Experimental
description: Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the high dose of KBP-COVID-19
arm group label: Placebo
arm group type: Placebo Comparator
description: Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive placebo
intervention type: Biological
intervention name: Low Dose of KBP-COVID-19
description: Low Dose of KBP-COVID-19 and adjuvant
arm group label: Low Dose KBP-COVID-19 and adjuvant
intervention type: Biological
intervention name: High Dose of KBP-COVID-19
description: High Dose of KBP-COVID-19 and adjuvant
arm group label: High Dose KBP-COVID-19 and adjuvant
intervention type: Biological
intervention name: Placebo
description: Buffered saline solution
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hugh Haydon
role: Study Director
affiliation: Kentucky BioProcessing
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
ipd description: Plan is to share study data by dosing group in publications