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This is a Phase 1/2a clinical trial to assess the safety and immunogenicity of AdCLD-CoV19 in healthy adults.
Part A is conducted as dose-escalation, single-center, open-label, a Phase 1 clinical trial. Part B is conducted as multi-center, open-label, a Phase 2a clinical trial. In Part A, we assess safety in all dose groups and set suitable two doses for Part B. In Part B, we assess immune responses against SARS-CoV-2 and set suitable dose for next phase of clinical trial. DSMB will evaluate safety during the whole study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: low dose | Experimental | Subject will receive single dose of AdCLD-CoV19(2.5x10^10VP) as intramuscular injection. |
|
| Group 2: middle dose | Experimental | Subject will receive single dose of AdCLD-CoV19(5.0x10^10VP) as intramuscular injection. |
|
| Group 3: high dose | Experimental | Subject will receive single dose of AdCLD-CoV19(1.0x10^11VP) as intramuscular injection. |
|
| Group 4: selected dose | Experimental | Subject will receive single dose of AdCLD-CoV19 as intramuscular injection. |
|
| Group 5: selected dose | Experimental | Subject will receive single dose of AdCLD-CoV19 as intramuscular injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdCLD-CoV19 | Biological | Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of solicited adverse events(AEs) | Through 7 days post-vaccination | |
| Incidence of unsolicited AEs | Through 28, 56 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events(SAEs) | Through 12 months post-vaccination | |
| Incidence of adverse events of special interest(AESIs) | Through 12 months post-vaccination | |
| Measure | Description | Time Frame |
|---|---|---|
| SCR of neutralization antibody using pseudovirus | 2, 4, 8, 26, 52 weeks post-vaccination | |
| GMT of neutralization antibody using pseudovirus | 2, 4, 8, 26, 52 weeks post-vaccination | |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | Province | South Korea | |||
| The Catholic University of Korea, ST. Vincent's Hospital |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Seroconversion rate(SCR) of neutralization antibody using wild type SARS-CoV-2 |
| 4, 8 weeks post-vaccination |
| Geometric mean titer(GMT) of neutralization antibody using wild type SARS-CoV-2 | 4, 8 weeks post-vaccination |
| GMT of S protein specific antibody | 2, 4, 8, 26, 52 weeks post-vaccination |
| Index of T cell response | 2, 4, 26, 52 weeks post-vaccination |
| GMT of S protein receptor binding domain(RBD) specific antibody |
| 2, 4, 8, 26, 52 weeks post-vaccination |
| Suwon |
| Province |
| South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | State | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | State | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |