Immunogenicity and Safety of AdCLD-CoV19-1 OMI As a Booster: a COVID-19 Preventive Vaccine in Healthy Volunteers

NCT05993325 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: COVENT-202
• Study Type: interventional
• Target: 4,000
• Locations: 2 countries
• Sites: 17

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

Conditions

COVID-19; Vaccines

Keywords

COVID-19; SARS-CoV-2; Omicron; B.1.1.529

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (12)

• 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.

  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.

  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.

  At 28 days post IP administration

• Proportion of immediate adverse events (AE)

  Within 30 minutes post IP administraiton

• Proportion of solicited local and systemic AE

  Within 7 days (Days 0 - 6) post IP administration

Other Outcomes (9)

• 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.

  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.

  At 28 days, 26, 52 weeks post IP administration.

Study Arms (2)

1 dose of AdCLD-CoV19-1 OMI

EXPERIMENTAL

Test group will receive 1 dose of AdCLD-CoV19-1 OMI

Biological: AdCLD-CoV19-1 OMI

1 dose of Comirnaty Bivalent

ACTIVE COMPARATOR

Control group will receive 1 dose of Comirnaty Bivalent

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

Interventions

AdCLD-CoV19-1 OMI BIOLOGICAL

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

1 dose of AdCLD-CoV19-1 OMI

Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran) BIOLOGICAL

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

1 dose of Comirnaty Bivalent

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Cellid Co., Ltd.: lead

Study Sites (17)

The Medical City-Iloilo

Iloilo City, Philippines

Location

West Visayas State University Medical Center

Iloilo City, Philippines

Location

Tropical Disease Foundation, Inc.

Makati, Philippines

Location

Far Eastern University - Nicanor Reyes Medical Foundation

Quezon City, Philippines

Location

Dong-a University Hospital

Busan, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, South Korea

Location

The Catholic University of Korea, ST. Vincent's Hospital

Gyeonggi-do, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

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

Seoul, South Korea

Location

Veterans Health Service Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 15, 2023
• Study Start: November 27, 2023
• Primary Completion: March 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (13); PH (4)