Back to resultsA Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
UB-612
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant female who previously participated in and completed two vaccinations in the V-122 Study.
- Women of childbearing potential and men must agree to practice medically effective contraception during study period.
- Able to understand the content and possible risks of informed consent and willing to sign the Informed Consent Form (ICF).
- Able to understand and agrees to comply with all study procedures and be available for all study visits.
- Ear temperature ≤ 38.0°C.
- At screening visit, at least 6 months after first vaccination in the V-122 study.
Exclusion Criteria
- Female who is pregnant or positive in pregnancy test at screening visit.
- Female who is breast-feeding or plans to breastfeed within 90 days after booster vaccination.
- Any acute illness, as determined by the study investigator 3 days before booster vaccination.
- Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before booster vaccination or expectation of such vaccines in the month after booster vaccination.
- Prior administration of subunit vaccine or inactivated vaccine in last 14 days before booster vaccination or expectation of receipt of such vaccines in the 14 days after booster vaccination.
- Any medical disease or condition that, in the opinion of the study investigator, may confound the results of the study or pose an additional risk to the subjects by their participation in the study.
- Previous exposure to SARS-CoV-2 or receipt of an investigational or EUA vaccine product for the prevention of COVID-19, MERS or SARS except UB-612.
- Subjects who take part in another clinical study, other than V-122 study, within 12 weeks prior to the day of informed consent.
- Prior administration of immunoglobulins and/or any blood products in last 4 months before booster vaccination.
- Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.
Sites / Locations
- China Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A group: 1 booster dose of UB-612 vaccine 100 μg
B group: 1 booster dose of UB-612 vaccine 100 μg
C group: 1 booster dose of UB-612 vaccine 100 μg
Arm Description
1 booster dose for subjects at UB-612 vaccine 10 μg in V-122 study.
1 booster dose for subjects at UB-612 vaccine 30 μg in V-122 study.
1 booster dose for subjects at UB-612 vaccine 100 μg in V-122 study.
Outcomes
Primary Outcome Measures
GMT of neutralizing antibody against SARS-CoV-2
Evaluation of Immunogenicity
GMT of neutralizing antibody against SARS-CoV-2
Evaluation of Immunogenicity
GMT of neutralizing antibody against SARS-CoV-2
Evaluation of Immunogenicity
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2
Evaluation of Immunogenicity
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2
Evaluation of Immunogenicity
Occurrence of adverse reactions and the percentage of subjects with ≥ Grade 3 adverse events
Evaluation of Safety
Secondary Outcome Measures
GMT of antigen-specific antibody (Anti-S1-RBD)
Evaluation of Immunogenicity
GMT of antigen-specific antibody (Anti-S1-RBD)
Evaluation of Immunogenicity
GMT of antigen-specific antibody (Anti-S1-RBD)
Evaluation of Immunogenicity
Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)
Evaluation of Immunogenicity
Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)
Evaluation of Immunogenicity
Correlation between the immune response detected by ELISA and live virus neutralization test
Evaluation of Immunogenicity
Occurrence of SAEs, AESIs, MAAEs and SAEs
Evaluation of Safety
Full Information
NCT ID
NCT04967742
First Posted
July 12, 2021
Last Updated
August 25, 2022
Sponsor
United Biomedical Inc., Asia
Collaborators
Vaxxinity, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04967742
Brief Title
A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine
Official Title
A Phase I, Open-Label Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 Vaccine in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
August 22, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Biomedical Inc., Asia
Collaborators
Vaxxinity, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A group: 1 booster dose of UB-612 vaccine 100 μg
Arm Type
Experimental
Arm Description
1 booster dose for subjects at UB-612 vaccine 10 μg in V-122 study.
Arm Title
B group: 1 booster dose of UB-612 vaccine 100 μg
Arm Type
Experimental
Arm Description
1 booster dose for subjects at UB-612 vaccine 30 μg in V-122 study.
Arm Title
C group: 1 booster dose of UB-612 vaccine 100 μg
Arm Type
Experimental
Arm Description
1 booster dose for subjects at UB-612 vaccine 100 μg in V-122 study.
Intervention Type
Biological
Intervention Name(s)
UB-612
Intervention Description
UB-612 includes a designer S1-RBD-sFc fusion protein formulated with designer Th and CTL epitope peptides selected from immunodominant M, S2 and N regions known to bind to human MHC I and II.
Primary Outcome Measure Information:
Title
GMT of neutralizing antibody against SARS-CoV-2
Description
Evaluation of Immunogenicity
Time Frame
Day 1
Title
GMT of neutralizing antibody against SARS-CoV-2
Description
Evaluation of Immunogenicity
Time Frame
Day 15
Title
GMT of neutralizing antibody against SARS-CoV-2
Description
Evaluation of Immunogenicity
Time Frame
Day 85
Title
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2
Description
Evaluation of Immunogenicity
Time Frame
Day 15
Title
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2
Description
Evaluation of Immunogenicity
Time Frame
Day 85
Title
Occurrence of adverse reactions and the percentage of subjects with ≥ Grade 3 adverse events
Description
Evaluation of Safety
Time Frame
Within 7 days after vaccination
Secondary Outcome Measure Information:
Title
GMT of antigen-specific antibody (Anti-S1-RBD)
Description
Evaluation of Immunogenicity
Time Frame
Day 1
Title
GMT of antigen-specific antibody (Anti-S1-RBD)
Description
Evaluation of Immunogenicity
Time Frame
Day 15
Title
GMT of antigen-specific antibody (Anti-S1-RBD)
Description
Evaluation of Immunogenicity
Time Frame
Day 85
Title
Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)
Description
Evaluation of Immunogenicity
Time Frame
Day 15
Title
Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)
Description
Evaluation of Immunogenicity
Time Frame
Day 85
Title
Correlation between the immune response detected by ELISA and live virus neutralization test
Description
Evaluation of Immunogenicity
Time Frame
During the study period
Title
Occurrence of SAEs, AESIs, MAAEs and SAEs
Description
Evaluation of Safety
Time Frame
During the study period
Other Pre-specified Outcome Measures:
Title
T cell responses to UB-612 COVID-19 Vaccine
Description
Evaluation of Immunogenicity
Time Frame
Day 1
Title
T cell responses to UB-612 COVID-19 Vaccine
Description
Evaluation of Immunogenicity
Time Frame
Day 15
Title
T cell responses to UB-612 COVID-19 Vaccine
Description
Evaluation of Immunogenicity
Time Frame
Day 85
Title
GMT of neutralizing antibody against SARS-CoV-2 variants
Description
Evaluation of Immunogenicity
Time Frame
Day 1
Title
GMT of neutralizing antibody against SARS-CoV-2 variants
Description
Evaluation of Immunogenicity
Time Frame
Day 15
Title
GMT of neutralizing antibody against SARS-CoV-2 variants
Description
Evaluation of Immunogenicity
Time Frame
Day 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Male or non-pregnant female who previously participated in and completed two vaccinations in the V-122 Study.
Women of childbearing potential and men must agree to practice medically effective contraception during study period.
Able to understand the content and possible risks of informed consent and willing to sign the Informed Consent Form (ICF).
Able to understand and agrees to comply with all study procedures and be available for all study visits.
Ear temperature ≤ 38.0°C.
At screening visit, at least 6 months after first vaccination in the V-122 study.
Exclusion Criteria
Female who is pregnant or positive in pregnancy test at screening visit.
Female who is breast-feeding or plans to breastfeed within 90 days after booster vaccination.
Any acute illness, as determined by the study investigator 3 days before booster vaccination.
Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before booster vaccination or expectation of such vaccines in the month after booster vaccination.
Prior administration of subunit vaccine or inactivated vaccine in last 14 days before booster vaccination or expectation of receipt of such vaccines in the 14 days after booster vaccination.
Any medical disease or condition that, in the opinion of the study investigator, may confound the results of the study or pose an additional risk to the subjects by their participation in the study.
Previous exposure to SARS-CoV-2 or receipt of an investigational or EUA vaccine product for the prevention of COVID-19, MERS or SARS except UB-612.
Subjects who take part in another clinical study, other than V-122 study, within 12 weeks prior to the day of informed consent.
Prior administration of immunoglobulins and/or any blood products in last 4 months before booster vaccination.
Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Yi Wang, Ph.D
Organizational Affiliation
United Biomedical Inc., Asia
Official's Role
Study Chair
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
35316221
Citation
Wang CY, Hwang KP, Kuo HK, Peng WJ, Shen YH, Kuo BS, Huang JH, Liu H, Ho YH, Lin F, Ding S, Liu Z, Wu HT, Huang CT, Lee YJ, Liu MC, Yang YC, Lu PL, Tsai HC, Lee CH, Shi ZY, Liu CE, Liao CH, Chang FY, Chen HC, Wang FD, Hou KL, Cheng J, Wang MS, Yang YT, Chiu HC, Jiang MH, Shih HY, Shen HY, Chang PY, Lan YR, Chen CT, Lin YL, Liang JJ, Liao CC, Chou YC, Morris MK, Hanson CV, Guirakhoo F, Hellerstein M, Yu HJ, King CC, Kemp T, Heppner DG, Monath TP. A multitope SARS-CoV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants. J Clin Invest. 2022 May 16;132(10):e157707. doi: 10.1172/JCI157707.
Results Reference
derived
Learn more about this trial
A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine
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