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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
320
20 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle
250 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle
50 participants will receive placebo via intramuscular injection in the deltoid muscle
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
Proportion of immediate adverse events (AE)
Proportion of immediate AE within 30 minutes post dose injection.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Inha University Hospital
Incheon, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 2, 4 weeks post dose injection
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 2, 26, 52 weeks post dose injection