NCT04473690

KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers

A Phase I/II, First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of TAP-COVID-19 SARS-CoV-2 Vaccine With CpG Adjuvant in Healthy Adults Aged 18-49 and 50-85

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: KBio Inc · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is an First In Human (FIH), observer-blinded, randomized, placebo-controlled, parallel group study to evaluate the safety and immunogenicity of KBP-COVID-19 plus CPG adjuvant vaccine in healthy adult subjects in 2 age groups, Part A (18-49 years) and Part B (50-85 years).

Detailed description

Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization. Approximately 90 eligible healthy adults ages 18-49 years (inclusive) will be enrolled for Part A and 90 eligible healthy seronegative adults ages 50-85 years will be enrolled for Part B. Sentinel dosing (three subjects in each group) will be utilized in this FIH study. Sentinel cohorts will be used for the following groups: Part A (18-49 years) low dose Part B (50-85 years) low dose Part A (18-49 years) high dose Part B (50-85 years) high dose Overall, subjects will be randomized in a 1:1:1 ratio to receive study vaccine or placebo by IM injection on Days 1 and 22. All study visits will be conducted at the clinical sites on an outpatient basis. Subjects will participate in the study for approximately 1 year from the first dose.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	Low Dose of KBP-COVID-19	Low Dose of KBP-COVID-19 and adjuvant
BIOLOGICAL	High Dose of KBP-COVID-19	High Dose of KBP-COVID-19 and adjuvant
BIOLOGICAL	Placebo	Buffered saline solution

Timeline

• Start date: 2020-12-30
• Primary completion: 2022-05-31
• Completion: 2022-10-14
• First posted: 2020-07-16
• Last updated: 2025-05-18
• Results posted: 2025-05-18

Locations

8 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study