A Study to Evaluate the Ability of UB-612 COVID-19 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines.

NCT05167253 | Withdrawn Phase 1

• 1 other identifier: V-125
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study to evaluate the ability of UB-612 vaccine to boost immunity of subjects who previously received two doses of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses.

Conditions

COVID-19

Keywords

SARS-CoV-2; COVID-19 Vaccine

Outcome Measures

Primary Outcomes (5)

• Safety and tolerability

  * Local solicited adverse events * Systemic solicited adverse events * Skin allergic reactions

  within 7 days after vaccination

• Safety and tolerability

  • Unsolicited adverse events

  28 days after vaccination

• Immunogenicity

  • Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild type

  14 days after vaccination

• Immunogenicity

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

  14 days after vaccination

• Immunogenicity

  • Geometric mean fold increase (GMFI) of neutralizing antibody against SARS-CoV-2 wild type

  14 days after vaccination

Secondary Outcomes (24)

• Safety

  Day 1

• Safety

  14 days after vaccination

• Safety

  28 days after vaccination

• Safety

  6 months after vaccination

• Evaluation of safety of hematology and biochemistry

  Pre-vaccination

Study Arms (1)

UB-612 100 μg, 0.5 mL

EXPERIMENTAL

All subjects will be enrolled to receive one dose of 100 μg UB-612 vaccine

Biological: UB-612

Interventions

UB-612 BIOLOGICAL

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.

UB-612 100 μg, 0.5 mL

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 enrolment.
• Fully vaccinated with two injections of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses. The second dose of AstraZeneca COVID-19 vaccine (ChAdOx1-S) must have been administered more than six (6) months from study Day 1. The CDC COVID-19 Vaccination Record Card or appropriate documentation (e.g., medical records) will be required for documentation.
• Women of childbearing potential and men must agree to practice medically effective contraception from vaccination until 30 days after the vaccination.
• Participant or the participant's legal representative must understand the procedures of the study and is 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.
• Must be able to read, understand, and complete the protocol-required questionnaires and/or diary.
• Negative serological test for Hepatitis B surface antigen (HBsAg), HCV RNA and HIV antibody
• Negative results of SARS-CoV-2 N protein IgG ELISA
• Negative result of RT-PCR screening of nasopharyngeal or throat swabs for SARS-CoV-2.
• Ear temperature ≤ 38.0°C.
• Indexes of hematology, biochemistry and immunology laboratory tests are within the normal ranges, or not clinically significant as judged by investigators

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 vaccination administration or plans to become pregnant from the time of study vaccination through 30 days after the administration of the study vaccine.
• Female who is breast-feeding or plans to breastfeed from the time of the study vaccination through 30 days after the administration of the study vaccine.
• Investigational non-coronavirus vaccines: previous receipt of an investigational vaccine (non-coronavirus) within 1 year before the planned administration of study vaccine.
• Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before the study vaccine or expectation of such vaccines in the month after the study vaccine.
• Prior administration of subunit vaccine or inactivated vaccine in last 14 days before the study vaccine or expectation of receipt of such vaccines in the 14 days after the study vaccine.
• Judged by the investigator on the basis of evidence or medical history, immunosuppressive or immunodeficient state, autoimmune diseases, chronic kidney disease (with dialysis), asplenia, or recurrent severe infections.
• Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before the study vaccination.
• Receipt of short-term systemic corticosteroids. Study intervention administration should be delayed until systemic corticosteroid use has been discontinued for at least 28 days. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
• Has received systemic immunoglobulins or blood products within 4 months prior to enrollment.
• Loss or donation of blood over 500 mL within 3 months prior to screening visit or intention to donate blood or blood products for transfusion during the study.
• Participants who received specific anti-SARS-CoV-2 monoclonal antibody products at any time.
• Subjects who take part in another clinical study and are currently receiving or received any investigational intervention within 12 weeks prior to the day of informed consent.
• Platelet disorder or other bleeding disorder may cause injection contraindication.
• Any acute illness, as determined by the study investigator 3 days before vaccination.

Sponsors & Collaborators

• United Biomedical Inc., Asia: lead

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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: December 22, 2021
• Study Start: February 15, 2022
• Primary Completion: April 15, 2022
• Study Completion: October 31, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-02