Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT04439695|
Recruitment Status : Completed
First Posted : June 19, 2020
Last Update Posted : September 16, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Low dose Biological: Intermediate dose Biological: High dose Biological: Placebo||Phase 1|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||June 25, 2020|
|Actual Primary Completion Date :||February 25, 2021|
|Actual Study Completion Date :||July 28, 2021|
Experimental: Low Dose KBP-V001
Subjects in this group will receive the low dose of KBP-V001.
Biological: Low dose
Low dose of KBP-V001
Experimental: Intermediate KBP-V001
Subjects in this group will receive the intermediate dose of KBP-V001.
Biological: Intermediate dose
Intermediate dose of KBP-V001
Experimental: High Dose KBP-V001
Subjects in this group will receive the high dose of KBP-V001.
Biological: High dose
High dose of KBP-V001
Placebo Comparator: Placebo
Subjects in this group will receive placebo
Buffered Saline Solution
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 49 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04439695
|United States, Nebraska|
|Meridian Clinical Research|
|Omaha, Nebraska, United States, 68134|
|Study Director:||Hugh Haydon||Kentucky BioProcessing|
|Principal Investigator:||Brandon Essink, MD||Meridian Clinical Research|
|Responsible Party:||KBio Inc|
|Other Study ID Numbers:||
|First Posted:||June 19, 2020 Key Record Dates|
|Last Update Posted:||September 16, 2021|
|Last Verified:||September 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Plan is to share study data by dosing group in publications|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases