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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 dose of AdCLD-CoV19-1 OMI | Experimental | Test group will receive 1 dose of AdCLD-CoV19-1 OMI |
|
| 1 dose of Comirnaty Bivalent | Active Comparator | Control group will receive 1 dose of Comirnaty Bivalent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdCLD-CoV19-1 OMI | Biological | 3000 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular administration in the deltoid muscle |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| SRR, GMT, GMFR of SARS-CoV-2 Wuhan strain and Variants of concern (VOC) neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration. | At 28 days post IP administration | |
| SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 S protein-specific antibody measured by ELISA at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration. |
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
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
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.
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).
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:
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 |
|---|---|---|---|---|---|---|
| The Medical City-Iloilo | Iloilo City | Philippines | ||||
| West Visayas State University Medical Center |
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| Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran) | Biological | 1000 participants will receive investigational product (Comirnaty Bivalent) via intramuscular administration in the deltoid muscle |
|
| 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 |
| At 28 days post IP administration |
| Cellular immune response (CMI) measured by ELISpot at 28 days, 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration. | Cellular immune response (CMI: responder rate, spot-forming unit) measured by ELISpot at 28 days, 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration. | At 28 days, 26, 52 weeks post IP administration. |
| Differences of 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 previous COVID-19 vaccination series. | At 28 days post IP administration |
| Differences of 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 age. | At 28 days post IP administration |
| Proportion of COVID-19 cases confirmed by antigen test from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study. | Throughout the study duration, 12 months post IP administration |
| Proportion of severe COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study. | Throughout the study duration, 12 months post IP administration |
| Proportion of hospitalization due to COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study. | Throughout the study duration, 12 months post IP administration |
| Proportion of mortality due to COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study. | Throughout the study duration, 12 months post IP administration |
| Iloilo City |
| Philippines |
| Tropical Disease Foundation, Inc. | Makati | Philippines |
| Far Eastern University - Nicanor Reyes Medical Foundation | Quezon City | Philippines |
| Dong-a University Hospital | Busan | South Korea |
| Kyungpook National University Hospital | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Hallym University Dongtan Sacred Heart Hospital | Gyeonggi-do | South Korea |
| Korea University Ansan Hospital | 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 |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Seoul | South Korea |
| Veterans Health Service Medical Center | 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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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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