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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
4,000
3000 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular administration in the deltoid muscle
1000 participants will receive investigational product (Comirnaty Bivalent) via intramuscular administration in the deltoid muscle
The Medical City-Iloilo
Iloilo City, Philippines
West Visayas State University Medical Center
Iloilo City, Philippines
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.
Time frame: 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.
Time frame: At 28 days post IP administration
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.
Time frame: 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.
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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
...and 7 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 28 days (Days 0 - 27) post IP administration
Proportion of SAE
Time frame: Throughout the study duration, 12 months post IP administration
Proportion of Adverse Event Of Special Interest (AESI)
Time frame: Throughout the study duration, 12 months post IP administration
Proportion of Medically-Attended Adverse Events (MAAE)
Time frame: Throughout the study duration, 12 months post IP administration
Proportion of clinically significant changes in clinical laboratory tests
Time frame: At 28 days post IP administration
Proportion of clinically significant changes in vital signs
Time frame: At 28 days post IP administration
Proportion of clinically significant changes in physical examination
Time frame: At 28 days post IP administration