A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers

NCT04773067 | Terminated Phase 2 DMC

• 1 other identifier: V-205
• Study Type: interventional
• Target: 3,877
• Locations: 1 country
• Sites: 12

Brief Summary

This is a phase II, observer-blind, multiple-centre, randomized, placebo-controlled study to evaluate the immunogenicity, safety, tolerability and lot consistency of 2 doses of UB-612 vaccine in adolescent, younger and elderly adults. Around 3850 adult subjects will be randomized to be composed of the core group, while around 385 adolescents will be randomized to be the supplementary group. Subjects will be unblinded at Visit 5, and subjects in the vaccine group will be encouraged to have 3rd dose of vaccination.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (5)

• Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody

  Immunogenicity evaluation

  Day 57

• Seroconversion rate (SCR) of SARS-CoV-2 neutralizing antibody

  Immunogenicity evaluation

  Day 57

• Local reactions and systemic events

  Safety evaluation

  Up to 7 days following each dose

• Unsolicited adverse events

  Safety evaluation

  Day 1 to Day 57

• Medically attend adverse events (MAAEs), serious adverse events (SAEs), adverse event of special interests (AESIs) and antibody dependent enhancements (ADEs)

  Safety evaluation

  Day 1 to Day 365

Secondary Outcomes (5)

• SCR of anti-S1-RBD antibody

  Day 57

• GMT of SARS-CoV-2 neutralizing antibody

  Day 197 and 365

• GMT of anti-S1-RBD antibody

  Day 57, 197 and 365

• Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and antigen-specific antibody (Anti-S1-RBD)

  Day 57, 197 and 365

• Lot consistency by comparisons of GMT of SARS-CoV-2 neutralizing antibody

  Day 57

Other Outcomes (11)

• Antigen-specific interferon-gamma (IFN-γ) and IL-4 production measured by ELISpot

  Day 57 and 14 days post 3rd dose

• CD4+ and CD8+ T cell responses measured by flow cytometric assays

  Day 57 and 14 days post 3rd dose

• GMT of SARS-CoV-2 neutralizing antibody

  14 days post 3rd dose

Study Arms (2)

UB-612

EXPERIMENTAL

A proprietary high-precision designer S1-RBD protein based vaccine incorporating Th/CTL peptides to activate T cells.

Biological: UB-612

Placebo

PLACEBO COMPARATOR

Normal saline 0.9%.

Biological: Placebo

Interventions

UB-612 BIOLOGICAL

Around 3300 adult subjects and 330 adolescent subjects will receive 2 doses of 100 µg UB-612 vaccine. The subjects will be invited to have the 3rd dose after unblinded.

UB-612

Placebo BIOLOGICAL

Around 550 adult subjects and 55 adolescent subjects will receive 2 doses of normal saline 0.9%.

Placebo

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or non-pregnant female between the age of 12 to 85 years at time of enrolment.
• 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.
• Ear temperature ≤ 38.0°C.

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 (these subjects can be re-scheduled).
• Any major surgery one month before first vaccination (these subjects can be -rescheduled).
• Known HIV antibody positive.
• Known active hepatitis B and hepatitis C disease.
• Previous exposure to SARS-CoV-2 or receipt of an investigational or licensed product for the prevention of COVID-19, MERS or SARS.
• Have history of Guillain-Barre syndrome.
• Subjects who take part in another clinical study within 12 weeks prior to the day of informed consent.
• Immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease or immunosuppressive therapy.
• Subjects who plan to or are undergoing anti-cancer 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.

Sponsors & Collaborators

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

Study Sites (12)

Changhua Christian Hospital

Changhua, Taiwan

Location

Chang-Geng Medical Foundation Kaoshiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital

Taoyuan District, Taiwan

Location

Related Publications (2)

• Wang CY, Peng WJ, Kuo BS, Ho YH, Wang MS, Yang YT, Chang PY, Shen YH, Hwang KP. Toward a pan-SARS-CoV-2 vaccine targeting conserved epitopes on spike and non-spike proteins for potent, broad and durable immune responses. PLoS Pathog. 2023 Apr 20;19(4):e1010870. doi: 10.1371/journal.ppat.1010870. eCollection 2023 Apr.

  PMID: 37079651 DERIVED

• 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: January 30, 2021
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-06

Locations

TW (12)