NCT04967742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 covid19

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

August 5, 2021

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

August 26, 2022

Status Verified

February 1, 2022

Enrollment Period

17 days

First QC Date

July 12, 2021

Last Update Submit

August 25, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (7)

  • GMT of antigen-specific antibody (Anti-S1-RBD)

    Day 1

  • GMT of antigen-specific antibody (Anti-S1-RBD)

    Day 15

  • GMT of antigen-specific antibody (Anti-S1-RBD)

    Day 85

  • Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)

    Day 15

  • Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)

    Day 85

  • +2 more secondary outcomes

Other Outcomes (6)

  • T cell responses to UB-612 COVID-19 Vaccine

    Day 1

  • T cell responses to UB-612 COVID-19 Vaccine

    Day 15

  • T cell responses to UB-612 COVID-19 Vaccine

    Day 85

  • +3 more other outcomes

Study Arms (3)

A group: 1 booster dose of UB-612 vaccine 100 μg

EXPERIMENTAL

1 booster dose for subjects at UB-612 vaccine 10 μg in V-122 study.

Biological: UB-612

B group: 1 booster dose of UB-612 vaccine 100 μg

EXPERIMENTAL

1 booster dose for subjects at UB-612 vaccine 30 μg in V-122 study.

Biological: UB-612

C group: 1 booster dose of UB-612 vaccine 100 μg

EXPERIMENTAL

1 booster dose for subjects at UB-612 vaccine 100 μg in V-122 study.

Biological: UB-612

Interventions

UB-612BIOLOGICAL

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.

A group: 1 booster dose of UB-612 vaccine 100 μgB group: 1 booster dose of UB-612 vaccine 100 μgC group: 1 booster dose of UB-612 vaccine 100 μg

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 35316221DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

UB-612 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chang-Yi Wang, Ph.D

    United Biomedical Inc., Asia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 20, 2021

Study Start

August 5, 2021

Primary Completion

August 22, 2021

Study Completion

October 31, 2021

Last Updated

August 26, 2022

Record last verified: 2022-02

Locations

TW(1)