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KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers

NCT04473690 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-05-18

Study results available
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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).

Conditions

  • Covid19

Interventions

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

Sponsors & Collaborators

  • KBio Inc

    lead INDUSTRY

Principal Investigators

  • Barry Bratcher · KBio Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-30
Primary Completion
2022-05-31
Completion
2022-10-14
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04473690 on ClinicalTrials.gov