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

NCT04439695 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: KBP-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza; Vaccine; Influenza Vaccine

Outcome Measures

Primary Outcomes (2)

• Solicited administration site reactions

  Occurrences of Adverse Events

  7 days after vaccination

• Solicited systemic events

  Occurrences of Adverse Events

  7 days after vaccination

Secondary Outcomes (3)

• Number of Unsolicited Adverse Events

  43 days after vaccination

• Number of Serious Adverse Events and Medically Attended Events

  181 days after vaccination

• Vaccine HAI antibody Titers

  Day 1, 29, 43, 181

Study Arms (4)

Low Dose KBP-V001

EXPERIMENTAL

Subjects in this group will receive the low dose of KBP-V001.

Biological: Low dose

Intermediate KBP-V001

EXPERIMENTAL

Subjects in this group will receive the intermediate dose of KBP-V001.

Biological: Intermediate dose

High Dose KBP-V001

EXPERIMENTAL

Subjects in this group will receive the high dose of KBP-V001.

Biological: High dose

Placebo

PLACEBO COMPARATOR

Subjects in this group will receive placebo

Biological: Placebo

Interventions

Low dose BIOLOGICAL

Low dose of KBP-V001

Low Dose KBP-V001

Intermediate dose BIOLOGICAL

Intermediate dose of KBP-V001

Intermediate KBP-V001

High dose BIOLOGICAL

High dose of KBP-V001

High Dose KBP-V001

Placebo BIOLOGICAL

Buffered Saline Solution

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KBio Inc: lead

Study Sites (1)

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Hugh Haydon

  Kentucky BioProcessing

  STUDY DIRECTOR

• Brandon Essink, MD

  Meridian Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: June 25, 2020
• Primary Completion: February 25, 2021
• Study Completion: July 28, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)