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

NCT04545749 | Completed Phase 1 DMC

• 1 other identifier: V-122
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, open-label, dose-escalation clinical study to evaluate the safety, tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults, aged from 20 to 55 years old.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Safety of UB-612 vaccine

  1. Occurrence of adverse reactions within 7 days after vaccination 2. Percentage of subjects with ≥ Grade 3 adverse events within 7 days after vaccination

  7 days following vaccination

Secondary Outcomes (6)

• Safety

  Day 0 to Day 56

• Safety

  Day 29 to Day 196

• Safety

  Day 0 to Day 196

• Immunogenicity

  Day 14, 28, 42, 56, 112, and 196

• Immunogenicity

  Day 14, 28, 42, 56, 112, and 196

Study Arms (3)

Group A (Low dose)

EXPERIMENTAL

20 subjects will be enrolled to receive low dose of UB-612 vaccine.

Biological: UB-612

Group B (Medium dose)

EXPERIMENTAL

20 subjects will be enrolled to receive medium dose of UB-612 vaccine.

Biological: UB-612

Group C (High dose)

EXPERIMENTAL

20 subjects will be enrolled to receive high dose of UB-612 vaccine.

Biological: UB-612

Interventions

UB-612 BIOLOGICAL

UB-612 is a proprietary high-precision designer S1-RBD-protein based vaccine incorporating a Th/CTL epitope peptide pool which could bind to human MHC-I and MHC-II to activate T cells.

Group A (Low dose); Group B (Medium dose); Group C (High dose)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or non-pregnant female between the age of 20 and 55 years at time of enrollment.
• Women of childbearing potential and men must agree to practice medically effective contraception from first vaccination until 3 months after the last vaccination.
• 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.
• Negative serological test for Hepatitis B surface antigen (HBsAg), HCV RNA and HIV antibody screening.
• Negative in serum antibodies (IgG) against SARS-CoV-2 ELISA.
• Negative result of RT-PCR screening of nasopharyngeal or throat swabs for SARS-CoV-2.
• Ear temperature ≤ 38.0°C.
• The body mass index (BMI) of 18-30 kg/m2, inclusive, at screening.
• Indexes of blood routine, biochemistry and other laboratory tests are within the normal ranges, or not clinically significant as judged by investigators.
• Judged to be healthy by the investigator on the basis of medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory tests performed at screening.

You may not qualify if:

• History of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
• Female who is pregnant or positive in pregnancy test at screening or just prior to each vaccination administration.
• Female who is breast-feeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
• Any acute illness, as determined by the study investigator 3 days before first vaccination.
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
• Known history of SARS or MERS.
• Previous exposure to SARS-CoV-2 or receipt of an investigational vaccine product for the prevention of COVID-19, MERS or SARS.
• Subjects who take part in another clinical study within 12 weeks prior to the day of informed consent.
• With certain underlying medical conditions which are at increased risk for severe illness from COVID-19.
• Congenital or acquired angioedema.
• Immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease or immunosuppressive therapy.
• Platelet disorder or other bleeding disorder may cause injection contraindication.
• Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.
• Prior administration of immunoglobulins and/or any blood products in last 4 months before first vaccination.
• Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before first vaccination or expectation of such vaccines in the month after the second vaccination.

Sponsors & Collaborators

• United Biomedical Inc., Asia: lead
• Vaxxinity, Inc.: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, 404, 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: 35316221 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

UB-612 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory 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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 11, 2020
• Study Start: September 25, 2020
• Primary Completion: January 18, 2021
• Study Completion: May 24, 2021
• Last Updated: August 26, 2022

Record last verified: 2022-02

Locations

TW (1)