The immunogenicity and safety profiles of AdCLD-CoV19-1 (5.0×10\^10 VP/dose) will be assessed for 1-dose or 2-dose regimen in SARS-CoV-2 seronegative healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4
All 200 participants will receive 2 doses of investigational product by 2 months interval via intramuscular injection in the deltoid region
Korea University Ansan Hospital
Ansan, South Korea
Catholic University Seoul St.Mary's Hospital
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Proportion of immediate adverse events (AE)
• Proportion of immediate AE within 30 minutes post each dose injection
Time frame: Within 30 minutes post each dose injection
Proportion of solicited local and systemic AE
• Proportion of solicited local and systemic AEs within 7 days post each 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 each dose injection
Proportion of unsolicited AE
• Proportion of unsolicited AEs within 28 days post each 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 each dose injection
Proportion of SAE
• Proportion of any SAE from the vaccination throughout the entire study. An AE or suspected adverse reaction is considered "serious" if at any dose (including overdose): 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 end, an average of 14 months (12 months post second dose injection)
Proportion of Adverse Event Of Special Interest (AESI)
• Proportion of any AESI from the vaccination 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.
Time frame: Throughout the study duration, an average of 14 months (12 months post second dose injection)
Proportion of Medically-Attended Adverse Events (MAAE)
• Proportion of any MAAE from the vaccination 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, an average of 14 months (12 months post second dose injection)
Proportion of clinically significant changes in clinical safety laboratory parameters
Proportion of clinically significant changes in clinical safety laboratory parameters at 1, 2 and 4 weeks post each dose injection
Time frame: At 1, 2 and 4 weeks post each dose injection
Geometric Mean Titer of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (Neutralizing antibody)
Geometric Mean Titer (GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assay from baseline to 2 weeks post second dose injection, induced by 2 doses of AdCLD-CoV19-1 at 2-month interval and by 1 dose of AdCLD-CoV19-1 followed by 1 dose of placebo at 2-month interval
Time frame: At 2 weeks post second dose injection
Geometric Mean Fold Rise of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (Neutralizing antibody)
Geometric Mean Fold Rise (GMFR) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assay from baseline to 2 weeks post second dose injection, induced by 2 doses of AdCLD-CoV19-1 at 2-month interval and by 1 dose of AdCLD-CoV19-1 followed by 1 dose of placebo at 2-month interval
Time frame: At 2 weeks post second dose injection
Proportion of participants achieving seroresponse of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (Neutralizing antibody)
Proportion of participants achieving seroresponse (SR defined as at least 4-fold increase from baseline) of wild-type virus neutralizing antibody titer from baseline to 2 weeks post second dose injection, induced by 2 doses of AdCLD-CoV19-1 at 2-month interval and by 1 dose of AdCLD-CoV19-1 followed by 1 dose of placebo at 2-month interval
Time frame: At 2 weeks post second dose injection
GMT of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (ELISA)
GMT of SARS-CoV-2 Spike-binding ELISA IgG antibody from baseline to 2 weeks post second dose injection, induced by 2 doses of AdCLD-CoV19-1 at 2-month interval and by 1 dose of AdCLD-CoV19-1 followed by 1 dose of placebo at 2-month interval
Time frame: At 2 weeks post second dose injection
GMFR of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (ELISA)
GMFR of SARS-CoV-2 Spike-binding ELISA IgG antibody from baseline to 2 weeks post second dose injection, induced by 2 doses of AdCLD-CoV19-1 at 2-month interval and by 1 dose of AdCLD-CoV19-1 followed by 1 dose of placebo at 2-month interval
Time frame: At 2 weeks post second dose injection
Proportion of participants achieving seroresponse of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (ELISA)
Proportion of participants achieving seroresponse (SR defined as at least 4-fold increase from baseline) of SARS-CoV-2 Spike-binding ELISA IgG antibody from baseline to 2 weeks post second dose injection, induced by 2 doses of AdCLD-CoV19-1 at 2-month interval and by 1 dose of AdCLD-CoV19-1 followed by 1 dose of placebo at 2-month interval
Time frame: At 2 weeks post second dose injection
GMT of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection (Neutralizing antibody)
GMT of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assay from baseline to and 1, 3, and 6 months post first dose injection, and at 1, 3, 6 and 12 months post second dose injection, induced by 1 and 2 doses of AdCLD-CoV19-1 respectively
Time frame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
GMFR of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection (Neutralizing antibody)
GMFR of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assay from baseline to and 1, 3, and 6 months post first dose injection, and at 1, 3, 6 and 12 months post second dose injection, induced by 1 and 2 doses of AdCLD-CoV19-1 respectively
Time frame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
Proportion of participants achieving seroresponse of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection (Neutralizing antibody)
Proportion of participants achieving seroresponse (SR defined as at least 4-fold increase from baseline) of wild-type virus neutralizing antibody titer from baseline to and 1, 3, and 6 months post first dose injection, and at 1, 3, 6 and 12 months post second dose injection, induced by 1 and 2 doses of AdCLD-CoV19-1 respectively
Time frame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
GMT of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection (ELISA)
GMT of SARS-CoV-2 Spike-binding ELISA IgG antibody from baseline to 2 weeks, and 1, 3, and 6 months post first dose injection, and at 1, 3, 6 and 12 months post second dose injection induced by 1 and 2 doses of AdCLD-CoV19-1, respectively
Time frame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
GMFR of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection (ELISA)
GMFR of SARS-CoV-2 Spike-binding ELISA IgG antibody from baseline to 2 weeks, and 1, 3, and 6 months post first dose injection, and at 1, 3, 6 and 12 months post second dose injection induced by 1 and 2 doses of AdCLD-CoV19-1, respectively
Time frame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
Proportion of participants achieving seroresponse of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection (ELISA)
Proportion of participants achieving seroresponse (SR defined as at least 4-fold increase from baseline) of SARS-CoV-2 Spike-binding ELISA IgG antibody from baseline to 2 weeks, and 1, 3, and 6 months post first dose injection, and at 1, 3, 6 and 12 months post second dose injection induced by 1 and 2 doses of AdCLD-CoV19-1, respectively
Time frame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
Cell Mediated Immunity (CMI) of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks, 6 months post first dose injection and 2 weeks, 6 and 12 months post second 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 weeks, 6 months post first dose injection and 2 weeks, 6 and 12 months post second dose injection induced by 1 and 2 doses of AdCLD-CoV19-1, respectively
Time frame: At 2 weeks, 6 months post first dose injection and 2 weeks, 6 and 12 months post second dose injection
Cell Mediated Immunity (CMI) of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks, 6 months post first dose injection and 2 weeks, 6 and 12 months post second 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 weeks, 6 months post first dose injection and 2 weeks, 6 and 12 months post second dose injection induced by 1 and 2 doses of AdCLD-CoV19-1, respectively
Time frame: At 2 weeks, 6 months post first dose injection and 2 weeks, 6 and 12 months post second dose injection