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The safety and immunogenicity 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 dose of AdCLD-CoV19-1 OMI (Part A) | Experimental | Group in Part A will receive 1 dose of AdCLD-CoV19-1 OMI |
|
| 1 dose of AdCLD-CoV19-1 OMI (Part B) | Experimental | Group 1 in Part B will receive 1 dose of AdCLD-CoV19-1 OMI |
|
| Placebo (Part B) | Placebo Comparator | Group 2 in Part B will receive 1 dose of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdCLD-CoV19-1 OMI (Part A) | Biological | 20 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of immediate adverse events (AE) | Proportion of immediate AE within 30 minutes post dose injection. | Within 30 minutes post dose injection |
| Proportion of solicited local and systemic AE | Proportion of solicited local and systemic AEs within 7 days post dose injection. Local AEs at the site of injection: Pain, tenderness, erythema/redness, swelling/induration, pruritis. Systemic AEs: Fever, fatigue/general weakness, chill, headache, myalgia, arthralgia, diarrhea, nausea/vomiting, abdominal pain, mucocutaneous reaction/rash, urticaria, dizziness, cough, dyspnea. | Within 7 days (Days 0 - 6) post dose injection |
| Proportion of unsolicited AE | Proportion of unsolicited AEs within 28 days post dose injection. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited AEs). | Within 28 days post dose injection |
| Proportion of SAE | Proportion of any SAE from the administration throughout the entire study. An AE or suspected adverse reaction is considered "serious": Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. | Throughout the study duration, 12 months post dose injection |
| Proportion of Adverse Event Of Special Interest (AESI) | Proportion of any AESI from the administration throughout the entire study. AESI are categorized into 1) AESIs included because they are seen with COVID-19 Disease, 2) AESI included because they have a proven or theoretical association with immunization in general, 3) AESI included because they have a proven or theoretical association with specific vaccine platform(s). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody) | Proportion of participants achieving seroresponse (SR defined as at least 2-fold increase from baseline) of wild-type virus neutralizing antibody titer from baseline to 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. |
| Measure | Description | Time Frame |
|---|---|---|
| SRR, GMT, GMFR of 1 dose of AdCLD-CoV19-1 OMI from baseline to 4 weeks post dose injection (Neutralizing antibody) | SRR, GMT, GMFR of neutralizing antibody to the SARS-CoV-2 Wuhan strain and Variants of concern (VOC) measured by wild-type virus neutralization assay from baseline to 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. | At 4 weeks post dose injection |
Inclusion Criteria:
(Part A) Individual aged between 19-64 years old and willing to provide written informed consent to participate study voluntarily.
(Part B) Individual aged 19 years and above and willing to provide written informed consent to participate study voluntarily.
Individual fall under one or more of the following;
Individual with body mass index (BMI) of 30.0 kg/m2 or less at screening visit.
Individual who agrees with using an effective birth control method for at least 4 weeks before the screening and during the study period.
Individual who agrees not to donate or transfuse blood (including whole blood, plasma components, platelet components, and platelet plasma components) during the study period.
Exclusion Criteria:
Individual who has history of COVID-19 or is considered infected within 16 weeks (112 days) prior to administration of investigational product.
Individual who has received other COVID-19 vaccine within 16 weeks (112 days) prior to administration of investigational product.
Individual who has been in close contact with a COVID-19 infected person, or has been classified as a confirmed or suspected COVID-19 patient within 14 days prior to administration of investigational product.
Individual determined to be clinically significantly abnormal by the screening outcome based on laboratory evaluations, electrocardiogram (ECG) and Chest X-ray.
Individual who has ant results of positive to HIV test, hepatitis B test, and hepatitis C test on screening.
Acute febrile illness with 38°C and above, or any suspected infectious diseases, or symptoms similar to COVID-19 (cough, shortness of breathe, chills, myalgia, headache, sore throat, loss of taste/smell, etc.) within 3 days prior to administration of investigational product.
Any serious medical or psychiatric disease which in opinion of investigator judges unable to participate
History of splenectomy.
History of SARS-CoV or MERS-CoV infection.
Known history of allergic or hypersensitivity to the components of investigational product.
Known history of serious adverse reactions, allergies or hypersensitivity related to vaccination.
History of urticaria within 5 years prior to administration of investigational product.
Individual with history of bleeding diathesis or thrombocytopenia, or history of severe bleeding or bruising after intramuscular or intravenous injection, or is receiving an anticoagulant (Those who receive low dose aspirin (less than 100mg/day) are not excluded).
Individual with hereditary or idiopathic angioneurotic edema.
Individual with solid organ or bone marrow transplantation.
Individual who is suspected or with history of substance abuse and alcohol abuse within 24 weeks prior to administration of investigational product.
History of SARS-CoV or MERS-CoV vaccination.
History of licensed drug for COVID-19 treatment or prevention aside from COVID-19 vaccine within 52 weeks prior to administration of investigational product.
Use of immunosuppressive or chronic use of systemic steroids within 6 weeks prior to administration of investigational product (External steroids, nasal spray and inhalants are allowed).
Individuals who has administered other investigational product or device within 24 weeks prior to screening visit.
Individual concomitantly enrolled or scheduled to be enrolled in another trial (including follow-up period).
Individual vaccinated or planned vaccination within 28 days prior and after the administration of investigational product.
Receipt of immunoglobulin or blood-derived products within 12 weeks prior to administration of investigational product.
Individual with scheduled surgery during the study period.
Pregnant or lactating women.
Individual directly related to the investigator and meets the following conditions:
Individual who is unfit for this study for any other reason in judgement of investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Dongtan Sacred Heart Hospital | Gyeonggi-do | South Korea | ||||
| Korea University Ansan Hospital |
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| AdCLD-CoV19-1 OMI (Part B) | Biological | 250 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle |
|
| Placebo (Part B) | Other | 50 participants will receive placebo via intramuscular injection in the deltoid muscle |
|
| Throughout the study duration, 12 months post dose injection |
| Proportion of Medically-Attended Adverse Events (MAAE) | Proportion of any MAAE from the administration throughout the entire study. Medically-attended AEs are AEs with medically-attended visits including hospital, emergency room, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically attended visits. | Throughout the study duration, 12 months post dose injection |
| Proportion of clinically significant changes in clinical safety laboratory parameters | Proportion of clinically significant changes in clinical safety laboratory parameters at 7, 14, 28 days post dose injection. | At 7, 14, 28 days post dose injection |
| Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody) | Proportion of participants achieving seroresponse (SR defined as at least 2-fold increase from baseline) of wild-type virus neutralizing antibody titer from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. | At 2, 4 weeks post dose injection |
| Geometric Mean Titer of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody) | Geometric Mean Titer (GMT) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. | At 2, 4 weeks post dose injection |
| Geometric Mean Fold Rise of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody) | Geometric Mean Fold Rise (GMFR) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. | At 2, 4 weeks post dose injection |
| At 12, 26, 52 weeks post dose injection |
| Geometric Mean Titer of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody) | Geometric Mean Titer (GMT) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. | At 12, 26, 52 weeks post dose injection |
| Geometric Mean Fold Rise of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody) | Geometric Mean Fold Rise (GMFR) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. | At 12, 26, 52 weeks post dose injection |
| Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4, 12, 26, 52 weeks post dose injection (ELISA) | Proportion of participants achieving seroresponse (SR defined as at least 2-fold increase from baseline) of SARS-CoV-2 B.1.1.529 Spike-binding ELISA IgG antibody from baseline to 2, 4, 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. | At 2, 4, 12, 26, 52 weeks post dose injection |
| GMT of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4, 12, 26, 52 weeks post dose injection (ELISA) | GMT of SARS-CoV-2 B.1.1.529 Spike-binding ELISA IgG antibody from baseline to 2, 4, 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. | At 2, 4, 12, 26, 52 weeks post dose injection |
| GMFR of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4, 12, 26, 52 weeks post dose injection (ELISA) | GMFR of SARS-CoV-2 B.1.1.529 Spike-binding ELISA IgG antibody from baseline to 2, 4, 12, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. | At 2, 4, 12, 26, 52 weeks post dose injection |
| Cell Mediated Immunity (CMI) of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 26, 52 weeks post dose injection (Proportion of responders by Interferon-γ (IFN-γ) ELISpot) | Proportion of responders as measured by Interferon-γ (IFN-γ) ELISpot from baseline to 2, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. | At 2, 26, 52 weeks post dose injection |
| Cell Mediated Immunity (CMI) of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 26, 52 weeks post dose injection (Median spot forming units by Interferon-γ (IFN-γ) ELISpot) | Median spot forming units as measured by Interferon-γ (IFN-γ) ELISpot from baseline to 2, 26, 52 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI. | At 2, 26, 52 weeks post dose injection |
| SRR, GMT, GMFR of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody) according to the recipients features. | SRR, GMT, GMFR of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI according to the recipients features as follows;
| At 2, 4 weeks post dose injection |
| Number of virologically-confirmed COVID-19 cases from 2 weeks post dose injection to the end of study period | Number of virologically-confirmed COVID-19 cases using Rapid Antigen Test Kit or RT-PCR from 2 weeks post dose injection to the end of study period with one or more symptoms of COVID-19 including fever, chill, cough, shortness of breath, fatigue, myalgia, headache, loss of taste or smell, pharyngitis, rhinorrhea, nausea, vomiting, diarrhea. | Throughout the study duration, 12 months post dose injection |
| Number of severe COVID-19 cases from 2 weeks post dose injection to the end of study period | Number of severe COVID-19 cases using Rapid Antigen Test Kit or RT-PCR from 2 weeks post dose injection to the end of study period with one or more symptoms of COVID-19 including:
| Throughout the study duration, 12 months post dose injection |
| Number of hospitalization due to COVID-19 from 2 weeks post dose injection to the end of study period | Number of hospitalization due to COVID-19 confirmed by using Rapid Antigen Test Kit or RT-PCR from 2 weeks post dose injection to the end of study period. | Throughout the study duration, 12 months post dose injection |
| Number of death due to COVID-19 from 2 weeks post dose injection to the end of study period | Number of death due to COVID-19 confirmed by using Rapid Antigen Test Kit or RT-PCR from 2 weeks post dose injection to the end of study period. | Throughout the study duration, 12 months post dose injection |
| Gyeonggi-do |
| South Korea |
| The Catholic University of Korea ST. Vincent's Hospital | Gyeonggi-do | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Inha University Hospital | Incheon | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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