A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Biological: UB-612

• Registration Number: NCT04967742
• Lead Sponsor: United Biomedical Inc., Asia

Brief Summary

This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study.

Detailed Description

This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study. 60 subjects will receive one booster dose of UB-612 vaccines 100 μg with the same dose which was offered in Phase II study, at least 6 months after first vaccination. In this study, there will be 3 clinical visits. Subjects will come to the clinics at Day 1, Day 15, and Day 85.

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-20
• Study Start: 2021-08-05
• Primary Completion: 2021-08-22
• Study Completion: 2021-10-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C group: 1 booster dose of UB-612 vaccine 100 μg	UB-612	1 booster dose for subjects at UB-612 vaccine 100 μg in V-122 study.
A group: 1 booster dose of UB-612 vaccine 100 μg	UB-612	1 booster dose for subjects at UB-612 vaccine 10 μg in V-122 study.
B group: 1 booster dose of UB-612 vaccine 100 μg	UB-612	1 booster dose for subjects at UB-612 vaccine 30 μg in V-122 study.

Primary Outcome Measures

Name	Time	Method
GMT of neutralizing antibody against SARS-CoV-2	Day 85	Evaluation of Immunogenicity
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2	Day 85	Evaluation of Immunogenicity
Occurrence of adverse reactions and the percentage of subjects with ≥ Grade 3 adverse events	Within 7 days after vaccination	Evaluation of Safety

Secondary Outcome Measures

Name	Time	Method
Correlation between the immune response detected by ELISA and live virus neutralization test	During the study period	Evaluation of Immunogenicity
Occurrence of SAEs, AESIs, MAAEs and SAEs	During the study period	Evaluation of Safety
GMT of antigen-specific antibody (Anti-S1-RBD)	Day 85	Evaluation of Immunogenicity
Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)	Day 85	Evaluation of Immunogenicity

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan