Immunogenicity and Safety of AdCLD-CoV19-1 OMI as a Booster: A COVID-19 Preventive Vaccine in Healthy Volunteers

Study Overview
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Brief Summary
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The immunogenicity and safety of AdCLD-CoV19-1 OMI (5.0x10^10 VP (0.5 mL)/dose/Vial) administered as a booster in healthy adults aged 19 years old and above will be evaluated. Outcome assessment will be performed in comparison with Comirnaty Bivalent.

Official Title
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A Phase III Multinational, Multicenter, Observer-Blinded, Randomized, Active-Controlled Trial to Evaluate the Immunogenicity and Safety of the Preventive COVID-19 Vaccine AdCLD-CoV19-1 OMI Administered as a Booster to Adults Aged 19 Years Old and Above

Conditions
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COVID-19, Vaccines

Intervention / Treatment
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* Biological: AdCLD-CoV19-1 OMI
* Biological: Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individual aged 19 and above and willing to provide written informed consent to participate study voluntarily. Individual fall under one or more of the following at the date of IP administration At least past 16 weeks (112 days) without additional COVID-19 vaccination since the last COVID-19 vaccination. At least past 16 weeks (112 days) since the release of quarantine due to COVID-19 confirmation. Individual who agrees to use medically acceptable contraceptive methods† for at least 4 weeks prior to screening and 12 weeks post IP administration. Individual who agrees not to donate or transfuse blood (including whole blood, plasma components, platelet components, platelet plasma components) throughout the study participation. Exclusion Criteria: Individual fall under one or more of the following at the date of IP administration History of COVID-19 within 16 weeks (-111 0 days) or considered to be infected prior to IP administration. History of receiving COVID-19 vaccine within 16 weeks (-111 0 days) prior to IP administration. Clinically significant abnormalities on clinical laboratory tests, electrocardiograms, and chest X-rays performed during screening visit. Positive HIV test result on the screening test. Acute febrile illness with (≥38°C), or any suspected infectious diseases, or COVID-19-like symptoms (cough, shortness of breath, chills, myalgia, headache, sore throat, loss of taste/smell, etc.) within 3 days prior to administration of IP. Any serious medical or psychiatric disease which in opinion of investigator judges unable to participate. Respiratory diseases: Asthma, Chronic Obstructive Pulmonary Disease (COPD), active or latent tuberculosis which require medication, or individual who has received treatment due to worsening of the listed respiratory disease within 5 years prior to administration of IP. Serious cardiovascular diseases: Congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, thrombocytopenia or venous thrombosis, capillary leakage syndrome, myocarditis, pericarditis, etc. Neurologic diseases: Epilepsy, seizure within past 3 years, migraine, stroke, encephalopathy, Guillain-Barre Syndrome, encephalomyelitis, transverse myelitis, etc. Malignant cancer diagnosed within past 5 years (skin basal cell and squamous cell carcinoma are excluded). Immune function disorders including autoimmune hypothyroidism, psoriasis. Immunodeficiency diseases. History of dependently administering psychotropic drugs or narcotic analgesics within 24 weeks prior to administration of IP, or psychiatric disease or behavioral impairment that, in the opinion of the investigator, could interfere with the participant's ability to participate in the study. Other hepatobiliary, renal, endocrine, urinary tract, muscular skeletal diseases which the investigator considers clinically significant. History of splenectomy. Known history of allergic or hypersensitivity to the components of IP. Known history of serious adverse reaction, allergies or hypersensitivity related to vaccination. Individual with history of bleeding diathesis or thrombocytopenia, or history of severe bleeding or bruising after intramuscular injection or venipuncture or is receiving an anticoagulant (Individual receiving low dose aspirin (less than 100mg/day) can be enrolled in judgement of investigator). History of hereditary or idiopathic angioneurotic edema. History of systemic urticaria within 5 years prior to administration of IP. Individual with history of solid organ or bone marrow transplantation. Individual who is suspected or with history of drug or alcohol abuse within 24 weeks prior to administration of IP. History of licensed drug for COVID-19 prevention aside from COVID-19 vaccine within 52 weeks prior to administration of IP. Use of immunosuppressive or chronic use of systemic steroids within 6 weeks prior to administration of IP (Topical steroids, nasal spray and inhalers are allowed). Immunosuppressive: Azathioprine, Cyclosporine, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, Cyclophosphamide, 6-Mercaptopurine, Methotrexate, Rapamycin, Leflunomide, etc. Chronic steroid: >10 mg/day prednisone equivalent for periods exceeding 14 days. Individual who has administered other investigational product or device within 24 weeks prior to screening visit. Individual who has received or planned to receive any other vaccines within 28 days prior and after the administration of IP (Flu vaccines can be administered up to 14 days prior to the date of IP administration). Receipt of immunoglobulin or blood-derived products within 12 weeks prior to administration of IP. Individual with scheduled surgery throughout the study period. Pregnant or lactating women. Individual directly related to the investigator and meets the following: Personnel relationship or subordinate-superior relationship (employees of the investigator's department, staffs of this trial). Students or researchers in the immediate department of the school to which the investigator belongs (e.g., medical university). Individual who is unfit for this study for any other reason in judgement of investigator.

Ages Eligible for Study
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Minimum Age: 19 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 dose of AdCLD-CoV19-1 OMI<br>Test group will receive 1 dose of AdCLD-CoV19-1 OMI | Biological: AdCLD-CoV19-1 OMI<br>* 3000 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular administration in the deltoid muscle<br>|
| Active Comparator: 1 dose of Comirnaty Bivalent<br>Control group will receive 1 dose of Comirnaty Bivalent | Biological: Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)<br>* 1000 participants will receive investigational product (Comirnaty Bivalent) via intramuscular administration in the deltoid muscle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of GMT of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration | Ratio of GMT of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration (GMT of AdCLD-CoV19-1 OMI / GMT of Comirnaty Bivalent). Geometric mean titer (GMT): The value of multiplying the antibody titer of all available subjects (N) and take the Nth order root value. | At 28 days post IP administration | 
| Difference in seroresponse rate (SRR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration | Difference in seroresponse rate (SRR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration (SRR of AdCLD-CoV19-1 OMI - SRR of Comirnaty Bivalent). Seroresponse rate (SRR): Proportion of subjects whose antibody titer rise at least 4-fold at the measurement point compared to baseline. The titer is defined as half of detection limit if the titer before administration is below detection limit. | At 28 days post IP administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SRR (proportion of subject who achieved seroresponse), GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration. | SRR (proportion of subject who achieved seroresponse), GMT (Geometric mean titer), GMFR (Ratio of GMT or GMC rise at the measurement point compared to baseline) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration. | At 26, 52 weeks post IP administration | 
| Differences in SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by serostatus of SARS-CoV-2 N protein antibody. | Differences in seroresponse rate (SRR), geometric mean titer (GMT), geometric mean fold rise (GMFR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by serostatus of SARS-CoV-2 N protein antibody. | At 28 days post IP administration | 
| Differences in SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by country. | Differences in seroresponse rate (SRR), geometric mean titer (GMT), geometric mean fold rise (GMFR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by country. | At 28 days post IP administration | 
| Proportion of immediate adverse events (AE) | Immediate adverse events occurred within 30 minutes (2 hours for ≥75 years old) post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration. | Within 30 minutes post IP administraiton | 
| Proportion of solicited local and systemic AE | Solicited AEs occurred within 7 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration. | Within 7 days (Days 0 - 6) post IP administration | 
| Proportion of unsolicited AE | Unsolicited AEs occurred within 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration. | Within 28 days (Days 0 - 27) post IP administration | 
| Proportion of SAE |  | Throughout the study duration, 12 months post IP administration | 
| Proportion of Adverse Event Of Special Interest (AESI) |  | Throughout the study duration, 12 months post IP administration | 
| Proportion of Medically-Attended Adverse Events (MAAE) |  | Throughout the study duration, 12 months post IP administration | 
| Proportion of clinically significant changes in clinical laboratory tests |  | At 28 days post IP administration | 
| Proportion of clinically significant changes in vital signs |  | At 28 days post IP administration | 
| Proportion of clinically significant changes in physical examination |  | At 28 days post IP administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, Omicron, B.1.1.529