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History of Changes for Study: NCT04439695
Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
Latest version (submitted September 14, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 17, 2020 None (earliest Version on record)
2 June 18, 2020 Arms and Interventions, Outcome Measures and Study Status
3 June 29, 2020 Recruitment Status, Study Status and Contacts/Locations
4 August 31, 2020 Study Status
5 December 10, 2020 Study Status
6 January 8, 2021 Study Status
7 February 10, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 April 12, 2021 Study Status
9 July 29, 2021 Study Status
10 August 30, 2021 Study Status
11 September 14, 2021 Recruitment Status and Study Status
Comparison Format:

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Study NCT04439695
Submitted Date:  June 17, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: KBP-101
Brief Title: Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2020
Overall Status: Not yet recruiting
Study Start: June 23, 2020
Primary Completion: October 24, 2020 [Anticipated]
Study Completion: January 30, 2021 [Anticipated]
First Submitted: June 17, 2020
First Submitted that
Met QC Criteria:
June 17, 2020
First Posted: June 19, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
June 17, 2020
Last Update Posted: June 19, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: KBio Inc
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Influenza
Keywords: Influenza
Vaccine
Influenza Vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group A
Subjects in this group will receive the low dose of KBP-V001.
Biological: Low dose
Low dose of KBP-V001
Experimental: Group B
Subjects in this group will receive the intermediate dose of KBP-V001.
Biological: Intermediate dose
Intermediate dose of KBP-V001
Experimental: Group C
Subjects in this group will receive the high dose of KBP-V001.
Biological: High dose
High dose of KBP-V001
Placebo Comparator: Group D
Subjects in this group will receive placebo
Biological: Placebo
Buffered Saline Solution
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Solicited administration site reactions
[ Time Frame: 7 days after vaccination ]

Occurrences of Adverse Events
2. Solicited systemic events
[ Time Frame: 7 days after vaccination ]

Occurrences of Adverse Events
Secondary Outcome Measures:
1. Unsolicited Adverse Events
[ Time Frame: 43 days after vaccination ]

Safety Endpoint
2. Serious Adverse Events and Medically Attended Events
[ Time Frame: 181 days after vaccination ]

Safety Endpoint
3. Vaccine HAI antibody Titers
[ Time Frame: Day 1, 29, 43, 181 ]

Vaccine HAI antibody Titers for each treatment group
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 49 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Oscar Guzman
Telephone: 336-741-5043
Email: guzmano@rjrt.com
Study Officials: Hugh Haydon
Study Director
Kentucky BioProcessing
Brandon Essink, MD
Principal Investigator
Meridian Clinical Research
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Plan is to share study data by dosing group in publications
Open or close this module References
Citations:
Links:
Available IPD/Information:

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