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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a phase I, open-label clinical 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. This study will enroll approximately 30 subjects aged 20 to 55 years. The previous COVID-19 vaccine series will have been completed at least six months before study enrollment. Both sexes should be evenly distributed in subjects. Subjects will be enrolled to receive one dose of 100 μg UB-612 vaccine at Day 1. The subjects will come to the clinics at Visit 1 (screening, Day -28 to -1), Visit 2 (Day 1, vaccination), Visit 3 (Day 15, 14 days after vaccination), Visit 4 (Day 29, 28 days after vaccination), Visit 5 (Day 169, 6 months after vaccination) and will receive phone calls at 7 days after vaccination for safety check.

Official Title
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A Phase I, Open-label Study to Evaluate the Ability of UB-612 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines

Conditions
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COVID-19

Intervention / Treatment
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* Biological: UB-612


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. Judged by the investigator on the basis of evidence or medical history, participants with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies) will be excluded. History of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ. Known history of SARS, MERS or SARS-CoV-2 infection. Alcoholism or substance abuser. Behavioral, cognitive, or psychiatric disease that, in the opinion of investigators, affects the participant's ability to understand and cooperate with all study protocol requirements. Employees at the investigator's site, of the Sponsor or the contract research organization (CRO) directly involved in the conduct of the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UB-612 100 μg, 0.5 mL<br>All subjects will be enrolled to receive one dose of 100 μg UB-612 vaccine | Biological: UB-612<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse events) AE of special interest Vaccine-associated enhanced disease Serious adverse events Medically attended adverse events | Day 1 | 
| Safety | Adverse events) AE of special interest Vaccine-associated enhanced disease Serious adverse events Medically attended adverse events | 14 days after vaccination | 
| Safety | Adverse events) AE of special interest Vaccine-associated enhanced disease Serious adverse events Medically attended adverse events | 28 days after vaccination | 
| Safety | Adverse events) AE of special interest Vaccine-associated enhanced disease Serious adverse events Medically attended adverse events | 6 months after vaccination | 
| Evaluation of safety of hematology and biochemistry | Change of safety laboratory measurement from pre-vaccination | Pre-vaccination | 
| Immunogenicity | • GMT of neutralizing antibody against SARS-CoV-2 wild type, antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody | 14 days after vaccination | 
| Immunogenicity | • SCR of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody | 14 days after vaccination | 
| Immunogenicity | • GMFI of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody | 14 days after vaccination | 
| Immunogenicity | • GMT of neutralizing antibody against SARS-CoV-2 wild type, antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody | 28 days after vaccination | 
| Immunogenicity | • SCR of neutralizing antibody against SARS-CoV-2 wild type, antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody | 28 days after vaccination | 
| Immunogenicity | • GMFI of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody | 28 days after vaccination | 
| Immunogenicity | • GMT of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody | 6 months after vaccination | 
| Immunogenicity | • SCR of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody | 6 months after vaccination | 
| Immunogenicity | • GMFI of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody | 6 months after vaccination | 
| Immunogenicity | • GMT of neutralizing antibody titers against SARS-CoV-2 variant | 14 days after vaccination | 
| Immunogenicity | • SCR of neutralizing antibody titers against SARS-CoV-2 variant | 14 days after vaccination | 
| Immunogenicity | • GMFI of neutralizing antibody titers against SARS-CoV-2 variant | 14 days after vaccination | 
| Immunogenicity | • Reduction fold of GMT compared with neutralizing antibody titers against SARS-CoV-2 wild type | 14 days after vaccination | 
| Immunogenicity | • GMT of neutralizing antibody titers against SARS-CoV-2 variant | 28 days after vaccination | 
| Immunogenicity | • SCR of neutralizing antibody titers against SARS-CoV-2 variant | 28 days after vaccination | 
| Immunogenicity | • GMFI of neutralizing antibody titers against SARS-CoV-2 variant | 28 days after vaccination | 
| Immunogenicity | • Reduction fold of GMT compared with neutralizing antibody titers against SARS-CoV-2 wild type | 28 days after vaccination | 
| Immunogenicity | • T cell responses | Day 1 | 
| Immunogenicity | • T cell responses | 14 days after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2; COVID-19 Vaccine