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

A Phase I, Open-Label Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 Vaccine in Healthy Adult Volunteers

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: UB-612

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• Inclusion Criteria

  1. Male or non-pregnant female who previously participated in and completed two vaccinations in the V-122 Study.
  2. Women of childbearing potential and men must agree to practice medically effective contraception during study period.
  3. Able to understand the content and possible risks of informed consent and willing to sign the Informed Consent Form (ICF).
  4. Able to understand and agrees to comply with all study procedures and be available for all study visits.
  5. Ear temperature ≤ 38.0°C.
  6. At screening visit, at least 6 months after first vaccination in the V-122 study.

• Exclusion Criteria

  1. Female who is pregnant or positive in pregnancy test at screening visit.
  2. Female who is breast-feeding or plans to breastfeed within 90 days after booster vaccination.
  3. Any acute illness, as determined by the study investigator 3 days before booster vaccination.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Subjects who take part in another clinical study, other than V-122 study, within 12 weeks prior to the day of informed consent.
  9. Prior administration of immunoglobulins and/or any blood products in last 4 months before booster vaccination.
  10. Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A group: 1 booster dose of UB-612 vaccine 100 μg; 1 booster dose for subjects at UB-612 vaccine 10 μg in V-122 study.	Biological: UB-612; 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.
Experimental: B group: 1 booster dose of UB-612 vaccine 100 μg; 1 booster dose for subjects at UB-612 vaccine 30 μg in V-122 study.	Biological: UB-612; 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.
Experimental: C group: 1 booster dose of UB-612 vaccine 100 μg; 1 booster dose for subjects at UB-612 vaccine 100 μg in V-122 study.	Biological: UB-612; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMT of neutralizing antibody against SARS-CoV-2	Evaluation of Immunogenicity	Day 1
GMT of neutralizing antibody against SARS-CoV-2	Evaluation of Immunogenicity	Day 15
GMT of neutralizing antibody against SARS-CoV-2	Evaluation of Immunogenicity	Day 85
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2	Evaluation of Immunogenicity	Day 15
Geometric mean fold increase of neutralizing antibody against SARS-CoV-2	Evaluation of Immunogenicity	Day 85
Occurrence of adverse reactions and the percentage of subjects with ≥ Grade 3 adverse events	Evaluation of Safety	Within 7 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMT of antigen-specific antibody (Anti-S1-RBD)	Evaluation of Immunogenicity	Day 1
GMT of antigen-specific antibody (Anti-S1-RBD)	Evaluation of Immunogenicity	Day 15
GMT of antigen-specific antibody (Anti-S1-RBD)	Evaluation of Immunogenicity	Day 85
Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)	Evaluation of Immunogenicity	Day 15
Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)	Evaluation of Immunogenicity	Day 85
Correlation between the immune response detected by ELISA and live virus neutralization test	Evaluation of Immunogenicity	During the study period
Occurrence of SAEs, AESIs, MAAEs and SAEs	Evaluation of Safety	During the study period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
T cell responses to UB-612 COVID-19 Vaccine	Evaluation of Immunogenicity	Day 1
T cell responses to UB-612 COVID-19 Vaccine	Evaluation of Immunogenicity	Day 15
T cell responses to UB-612 COVID-19 Vaccine	Evaluation of Immunogenicity	Day 85
GMT of neutralizing antibody against SARS-CoV-2 variants	Evaluation of Immunogenicity	Day 1
GMT of neutralizing antibody against SARS-CoV-2 variants	Evaluation of Immunogenicity	Day 15
GMT of neutralizing antibody against SARS-CoV-2 variants	Evaluation of Immunogenicity	Day 85

Collaborators and Investigators

• Sponsor: United Biomedical Inc., Asia
• Collaborators: Vaxxinity, Inc.
• Investigators: Study Chair: Chang-Yi Wang, Ph.D, United Biomedical Inc., Asia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): August 22, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: V-123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No