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

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

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.

Study Overview

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

Detailed Description

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. Up to 60 subjects (20 subjects per group) will be enrolled into this study. Subjects in each group will be enrolled to receive two doses of UB-612 vaccine at 28-day interval (Day 0 and Day 28).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male or non-pregnant female between the age of 20 and 55 years at time of enrollment.
2. Women of childbearing potential and men must agree to practice medically effective contraception from first vaccination until 3 months after the last vaccination.
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. Negative serological test for Hepatitis B surface antigen (HBsAg), HCV RNA and HIV antibody screening.
6. Negative in serum antibodies (IgG) against SARS-CoV-2 ELISA.
7. Negative result of RT-PCR screening of nasopharyngeal or throat swabs for SARS-CoV-2.
8. Ear temperature ≤ 38.0°C.
9. The body mass index (BMI) of 18-30 kg/m2, inclusive, at screening.
10. Indexes of blood routine, biochemistry and other laboratory tests are within the normal ranges, or not clinically significant as judged by investigators.
11. 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.

Exclusion Criteria:

1. History of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
2. Female who is pregnant or positive in pregnancy test at screening or just prior to each vaccination administration.
3. Female who is breast-feeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
4. Any acute illness, as determined by the study investigator 3 days before first vaccination.
5. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
6. Known history of SARS or MERS.
7. Previous exposure to SARS-CoV-2 or receipt of an investigational vaccine product for the prevention of COVID-19, MERS or SARS.
8. Subjects who take part in another clinical study within 12 weeks prior to the day of informed consent.
9. With certain underlying medical conditions which are at increased risk for severe illness from COVID-19.
10. Congenital or acquired angioedema.
11. Immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease or immunosuppressive therapy.
12. Platelet disorder or other bleeding disorder may cause injection contraindication.
13. Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.
14. Prior administration of immunoglobulins and/or any blood products in last 4 months before first vaccination.
15. 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.
16. Prior administration of subunit vaccine or inactivated vaccine in last 14 days before first vaccination or expectation of receipt of such vaccines in the 14 days after the second vaccination.
17. Current anti-tuberculosis (TB) therapy or history of TB.
18. Alcoholism or substance abuser.
19. History of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ.
20. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Low dose); 20 subjects will be enrolled to receive low dose of UB-612 vaccine.	Biological: UB-612; 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.
Experimental: Group B (Medium dose); 20 subjects will be enrolled to receive medium dose of UB-612 vaccine.	Biological: UB-612; 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.
Experimental: Group C (High dose); 20 subjects will be enrolled to receive high dose of UB-612 vaccine.	Biological: UB-612; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of UB-612 vaccine	Occurrence of adverse reactions within 7 days after vaccination; Percentage of subjects with ≥ Grade 3 adverse events within 7 days after vaccination	7 days following vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Occurrence of adverse events (AEs) till Day 56; Occurrence of serious adverse events (SAEs) till Day 56	Day 0 to Day 56
Safety	Occurrence of serious adverse events during the whole follow-up period	Day 29 to Day 196
Safety	Occurrence of adverse events of special interest during the study period	Day 0 to Day 196
Immunogenicity	Geometric mean titer (GMT) of antigen-specific antibody (Anti-S1-RBD)	Day 14, 28, 42, 56, 112, and 196
Immunogenicity	Seroconversion rate (SCR) of antigen-specific antibody (Anti-S1-RBD)	Day 14, 28, 42, 56, 112, and 196
Immunogenicity	Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)	Day 14, 28, 42, 56, 112, and 196

Collaborators and Investigators

• Sponsor: United Biomedical Inc., Asia
• Collaborators: Vaxxinity, Inc.

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): September 25, 2020
• Primary Completion (Actual): January 18, 2021
• Study Completion (Actual): May 24, 2021

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 11, 2020

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-122

Drug and device information, study documents

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