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

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: High dose; Biological: Placebo; Biological: Intermediate dose; Biological: Low dose

• Registration Number: NCT04439695
• Lead Sponsor: KBio Inc

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 Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Study Start: 2020-06-25
• Primary Completion: 2021-02-25
• Study Completion: 2021-07-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose KBP-V001	High dose	Subjects in this group will receive the high dose of KBP-V001.
Placebo	Placebo	Subjects in this group will receive placebo
Intermediate KBP-V001	Intermediate dose	Subjects in this group will receive the intermediate dose of KBP-V001.
Low Dose KBP-V001	Low dose	Subjects in this group will receive the low dose of KBP-V001.

Primary Outcome Measures

Name	Time	Method
Solicited administration site reactions	7 days after vaccination	Occurrences of Adverse Events
Solicited systemic events	7 days after vaccination	Occurrences of Adverse Events

Secondary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events and Medically Attended Events	181 days after vaccination	Safety Endpoint
Number of Unsolicited Adverse Events	43 days after vaccination	Safety Endpoint
Vaccine HAI antibody Titers	Day 1, 29, 43, 181	Vaccine HAI antibody Titers for each treatment group

Trial Locations

Locations (1)

Meridian Clinical Research; 🇺🇸 Omaha, Nebraska, United States