Official Title
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
Brief Summary

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 beevaluated. Outcome assessment will be performed in comparison with Comirnaty Bivalent.

Detailed Description

Not Provided

Active, not recruiting
COVID-19
Vaccines

Biological: AdCLD-CoV19-1 OMI

3000 participants will receive investigational product (AdCLD-CoV19-1 OMI) via
intramuscular administration in the deltoid muscle

Biological: Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)

1000 participants will receive investigational product (Comirnaty Bivalent) via
intramuscular administration in the deltoid muscle

Eligibility Criteria

Inclusion Criteria:

1. Individual aged 19 and above and willing to provide written informed consent to
participate study voluntarily.

2. 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.

3. Individual who agrees to use medically acceptable contraceptive methods† for at
least 4 weeks prior to screening and 12 weeks post IP administration.

4. 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:

1. 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.

2. Clinically significant abnormalities on clinical laboratory tests,
electrocardiograms, and chest X-rays performed during screening visit.

3. Positive HIV test result on the screening test.

4. 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.

5. 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.

6. History of splenectomy.

7. Known history of allergic or hypersensitivity to the components of IP.

8. Known history of serious adverse reaction, allergies or hypersensitivity related to
vaccination.

9. 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).

10. History of hereditary or idiopathic angioneurotic edema.

11. History of systemic urticaria within 5 years prior to administration of IP.

12. Individual with history of solid organ or bone marrow transplantation.

13. Individual who is suspected or with history of drug or alcohol abuse within 24 weeks
prior to administration of IP.

14. History of licensed drug for COVID-19 prevention aside from COVID-19 vaccine within
52 weeks prior to administration of IP.

15. 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.

16. Individual who has administered other investigational product or device within 24
weeks prior to screening visit.

17. 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).

18. Receipt of immunoglobulin or blood-derived products within 12 weeks prior to
administration of IP.

19. Individual with scheduled surgery throughout the study period.

20. Pregnant or lactating women.

21. 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).

22. Individual who is unfit for this study for any other reason in judgement of
investigator.

Eligibility Gender
All
Eligibility Age
Minimum: 19 Years ~ Maximum: N/A
Countries
Philippines
South Korea
Locations

The Medical City-Iloilo
Iloilo City 1711005, Philippines

West Visayas State University Medical Center
Iloilo City 1711005, Philippines

Tropical Disease Foundation, Inc.
Makati 1703414, Philippines

Far Eastern University - Nicanor Reyes Medical Foundation
Quezon City 1692192, Philippines

Dong-a University Hospital
Busan 1838524, South Korea

Kyungpook National University Hospital
Daegu 1835329, South Korea

Chungnam National University Hospital
Daejeon 1835235, South Korea

Chonnam National University Hospital
Gwangju 1841811, South Korea

Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do 6363696, South Korea

Korea University Ansan Hospital
Gyeonggi-do 6363696, South Korea

The Catholic University of Korea, ST. Vincent's Hospital
Gyeonggi-do 6363696, South Korea

Gachon University Gil Medical Center
Incheon 1843564, South Korea

Inha University Hospital
Incheon 1843564, South Korea

Hallym University Kangnam Sacred Heart Hospital
Seoul 1835848, South Korea

Korea University Guro Hospital
Seoul 1835848, South Korea

The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul 1835848, South Korea

Veterans Health Service Medical Center
Seoul 1835848, South Korea

Not Provided

Cellid Co., Ltd.
NCT Number
Keywords
Covid-19
SARS-CoV-2
Omicron
B.1.1.529
MeSH Terms
COVID-19
BNT162 Vaccine