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Safety and Immunogenicity of TAP-COVID-19 (KBP-201) Vaccine in Healthy Adults
NCT04473690Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2020
- Primary completion
- May 2022
- Countries
- 2
- Sponsor
- KBio
- Modality
- Recombinant Proteins and Enzymes, Recombinant Protein Vaccines
- Drugs
- KBP-201
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, randomised, double-blind trial of KBP-201 in coronavirus disease 2019 (COVID-19) (3 arms), sponsored by KBio. Primary endpoints: Solicited Administration Site Reactions and Solicited Systemic Events. Started Dec 2020; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Low Dose KBP-COVID-19
Low dose of KBP-201 vaccine + CpG adjuvant
High Dose KBP-COVID-19
High dose of KBP-201 vaccine + CpG adjuvant
Placebo
Buffered saline solution
03
Who it enrols
Healthy adults aged 18-85 with BMI 18-30, negative for SARS-CoV-2, HIV, HBV, and HCV, and no history of severe adverse reactions to vaccines or immunodeficiency.
04
Endpoints
Primary
Solicited Administration Site Reactions
Solicited Systemic Events
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