Status:
COMPLETED
Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
Lead Sponsor:
KBio Inc
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
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 r...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Have read, understood, and signed the informed consent form (ICF)
- Healthy adult males and females ages 18 to 49 years, inclusive at screening
- Body mass index (BMI) of ≥18 and ≤34 kg/m2 at screening
- Must be in general good health before study participation with no clinically relevant abnormalities that could interfere with study assessments
- 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).
- Female subjects of childbearing potential must have a negative urine pregnancy test before vaccination
- 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
- 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.
- History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
- Individuals with any elevated (Grade 2 or higher) laboratory test assessed as clinically significant by investigator at screening
- 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
- 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.
- 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)
- History of autoimmune or inflammatory disease
- Women currently pregnant, nursing, or planning a pregnancy between enrollment and 181 days after randomization
- History of a previous serious adverse reaction to any influenza vaccine
- History of Guillain-Barré Syndrome
- History of anaphylactic-type reaction to injected vaccines
- Known or suspected hypersensitivity to 1 or more of the components of TAP-V001
- History of illicit drug use or alcohol abuse in the year before screening
- Receipt of any influenza vaccine within 6 months before screening
- Receipt of any vaccine within 1 month before screening
- Acute illness or fever within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator)
- 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.
- 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.
- Individuals who plan to receive another vaccine, including seasonal influenza vaccine, during the entire 6-month study period.
Exclusion
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04439695
Start Date
June 25 2020
End Date
July 28 2021
Last Update
September 16 2021
Active Locations (1)
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1
Meridian Clinical Research
Omaha, Nebraska, United States, 68134