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Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04439695
Recruitment Status : Completed
First Posted : June 19, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
KBio Inc

Tracking Information
First Submitted Date  ICMJE June 17, 2020
First Posted Date  ICMJE June 19, 2020
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE June 25, 2020
Actual Primary Completion Date February 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
  • Solicited administration site reactions [ Time Frame: 7 days after vaccination ]
    Occurrences of Adverse Events
  • Solicited systemic events [ Time Frame: 7 days after vaccination ]
    Occurrences of Adverse Events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
  • Number of Unsolicited Adverse Events [ Time Frame: 43 days after vaccination ]
    Safety Endpoint
  • Number of Serious Adverse Events and Medically Attended Events [ Time Frame: 181 days after vaccination ]
    Safety Endpoint
  • Vaccine HAI antibody Titers [ Time Frame: Day 1, 29, 43, 181 ]
    Vaccine HAI antibody Titers for each treatment group
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
  • Unsolicited Adverse Events [ Time Frame: 43 days after vaccination ]
    Safety Endpoint
  • Serious Adverse Events and Medically Attended Events [ Time Frame: 181 days after vaccination ]
    Safety Endpoint
  • Vaccine HAI antibody Titers [ Time Frame: Day 1, 29, 43, 181 ]
    Vaccine HAI antibody Titers for each treatment group
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Low dose
    Low dose of KBP-V001
  • Biological: Intermediate dose
    Intermediate dose of KBP-V001
  • Biological: High dose
    High dose of KBP-V001
  • Biological: Placebo
    Buffered Saline Solution
Study Arms  ICMJE
  • Experimental: Low Dose KBP-V001
    Subjects in this group will receive the low dose of KBP-V001.
    Intervention: Biological: Low dose
  • Experimental: Intermediate KBP-V001
    Subjects in this group will receive the intermediate dose of KBP-V001.
    Intervention: Biological: Intermediate dose
  • Experimental: High Dose KBP-V001
    Subjects in this group will receive the high dose of KBP-V001.
    Intervention: Biological: High dose
  • Placebo Comparator: Placebo
    Subjects in this group will receive placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 28, 2021
Actual Primary Completion Date February 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Have read, understood, and signed the informed consent form (ICF)
  2. Healthy adult males and females ages 18 to 49 years, inclusive at screening
  3. Body mass index (BMI) of ≥18 and ≤34 kg/m2 at screening
  4. Must be in general good health before study participation with no clinically relevant abnormalities that could interfere with study assessments
  5. Women of childbearing potential (WOCBP) and men whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception during the study and for 3 months after the study completion. A female subject is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
  6. Female subjects of childbearing potential must have a negative urine pregnancy test before vaccination
  7. Must be able to attend all visits for the duration of the study and comply with all study procedures, including completion of Diary Card according to the study schedule.

Exclusion Criteria

  1. History of an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
  2. History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
  3. Individuals with any elevated (Grade 2 or higher) laboratory test assessed as clinically significant by investigator at screening
  4. Individuals with any elevated (Grade 2 or higher) liver function enzyme at screening, regardless of the appraisal of clinical significance (cannot be retested to qualify for study). See below the criteria for excluding subjects with elevated liver enzymes:

    • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST): >3 × upper limit of normal (ULN)
    • Total bilirubin: >2 × ULN
    • Alkaline phosphatase (ALP)/gamma-glutamyl transferase (GGT): >2.5 × ULN
  5. Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
  6. Long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (>800 μg/day of beclomethasone dipropionate or equivalent) within 6 months before screening (nasal and topical steroids are allowed)
  7. History of autoimmune or inflammatory disease
  8. Women currently pregnant, nursing, or planning a pregnancy between enrollment and 181 days after randomization
  9. History of a previous serious adverse reaction to any influenza vaccine
  10. History of Guillain-Barré Syndrome
  11. History of anaphylactic-type reaction to injected vaccines
  12. Known or suspected hypersensitivity to 1 or more of the components of TAP-V001
  13. History of illicit drug use or alcohol abuse in the year before screening
  14. Receipt of any influenza vaccine within 6 months before screening
  15. Receipt of any vaccine within 1 month before screening
  16. Acute illness or fever within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator)
  17. Individuals currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication); or who have received an experimental agent within 1 month before enrollment in this study; or who expect to receive another experimental agent during participation in this study; or who intend to donate blood during the study period.
  18. Receipt of immunoglobulin or another blood product within the 3 months before enrollment in this study or those who expect to receive immunoglobulin or another blood product during this study.
  19. Individuals who plan to receive another vaccine, including seasonal influenza vaccine, during the entire 6-month study period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04439695
Other Study ID Numbers  ICMJE KBP-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Plan is to share study data by dosing group in publications
Current Responsible Party KBio Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE KBio Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hugh Haydon Kentucky BioProcessing
Principal Investigator: Brandon Essink, MD Meridian Clinical Research
PRS Account KBio Inc
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP