COVID-19Phase 3COVID-19NCT05993325
Immunogenicity and Safety of AdCLD-CoV19-1 OMI As a Booster: a COVID-19 Preventive Vaccine in Healthy Volunteers
A Phase 3 study testing AdCLD-CoV19-1 OMI and Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran) in people with COVID-19 and Vaccines, run by Cellid Co., Ltd. at 17 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- What is being tested?
- AdCLD-CoV19-1 OMI and Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 27 Nov 2023to Nov 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- History of splenectomy.
- Known history of allergic or hypersensitivity to the components of IP.
- Known history of serious adverse reaction, allergies or hypersensitivity related to vaccination.
- 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).
- History of hereditary or idiopathic angioneurotic edema.
- History of systemic urticaria within 5 years prior to administration of IP.
- Individual with history of solid organ or bone marrow transplantation.
- Individual who is suspected or with history of drug or alcohol abuse within 24 weeks prior to administration of IP.
- History of licensed drug for COVID-19 prevention aside from COVID-19 vaccine within 52 weeks prior to administration of IP.
- 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.
- Individual who has administered other investigational product or device within 24 weeks prior to screening visit.
- 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).
- Receipt of immunoglobulin or blood-derived products within 12 weeks prior to administration of IP.
- Individual with scheduled surgery throughout the study period.
- Pregnant or lactating women.
- 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).
- Individual who is unfit for this study for any other reason in judgement of investigator.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
South Korea13 sites
Dong-a University Hospital
Busan
Kyungpook National University Hospital
Daegu
Chungnam National University Hospital
Daejeon
Chonnam National University Hospital
Gwangju
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do
Korea University Ansan Hospital
Gyeonggi-do
The Catholic University of Korea, ST. Vincent's Hospital
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Inha University Hospital
Incheon
Hallym University Kangnam Sacred Heart Hospital
Seoul
Korea University Guro Hospital
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul
Veterans Health Service Medical Center
Seoul
Philippines4 sites
The Medical City-Iloilo
Iloilo City
West Visayas State University Medical Center
Iloilo City
Tropical Disease Foundation, Inc.
Makati
Far Eastern University - Nicanor Reyes Medical Foundation
Quezon City
About this study
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
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.
- Being tested
- AdCLD-CoV19-1 OMI, Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)
- Keywords
- COVID-19, SARS-CoV-2, Omicron, B.1.1.529
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdCLD-CoV19-1 OMIBiological
3000 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular administration in the deltoid muscle
Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)Biological
1000 participants will receive investigational product (Comirnaty Bivalent) via intramuscular administration in the deltoid muscle
| Study group | Role | What they receive |
|---|---|---|
| 1 dose of AdCLD-CoV19-1 OMI | Experimental | Test group will receive 1 dose of AdCLD-CoV19-1 OMI Receives: Biological: AdCLD-CoV19-1 OMI |
| 1 dose of Comirnaty Bivalent | Active comparator | Control group will receive 1 dose of Comirnaty Bivalent Receives: Biological: Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 28 days (Days 0 - 27) post IP administration
Proportion of SAE
Measured: Throughout the study duration, 12 months post IP administration
Proportion of Adverse Event Of Special Interest (AESI)
Measured: Throughout the study duration, 12 months post IP administration
Proportion of Medically-Attended Adverse Events (MAAE)
Measured: Throughout the study duration, 12 months post IP administration
Proportion of clinically significant changes in clinical laboratory tests
Measured: At 28 days post IP administration
Proportion of clinically significant changes in vital signs
Measured: At 28 days post IP administration
Proportion of clinically significant changes in physical examination
Measured: At 28 days post IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start27 Nov 2023
- Primary completionMar 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cellid Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993325
- Sponsor's protocol ID
- COVENT-202
- Acronym
- COVID-19
- Status last verified
- Nov 2024
- First submitted
- 14 Aug 2023
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05993325
- Acronym / sponsor ID
- COVID-19 / COVENT-202
- Keywords
- COVID-19, SARS-CoV-2, Omicron, B.1.1.529
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Cellid Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 dose of AdCLD-CoV19-1 OMI | Experimental | Biological: AdCLD-CoV19-1 OMITest group will receive 1 dose of AdCLD-CoV19-1 OMI |
| 1 dose of Comirnaty Bivalent | Active comparator | Biological: Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)Control group will receive 1 dose of Comirnaty Bivalent |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 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.
Key exclusion criteria (36 listed)
- Individual fall under one or more of the following at the date of 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdCLD-CoV19-1 OMI3000 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular administration in the deltoid muscle | Biological | 1 dose of AdCLD-CoV19-1 OMI |
| Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)1000 participants will receive investigational product (Comirnaty Bivalent) via intramuscular administration in the deltoid muscle | Biological | 1 dose of Comirnaty Bivalent |
Primary outcome
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
Time frame: At 28 days post IP 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.
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
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 (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.
12 secondary outcomes
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.
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.
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.
Time frame: At 28 days post IP administration
Proportion of immediate adverse events (AE)
Time frame: Within 30 minutes post IP administraiton
Proportion of solicited local and systemic AE
Time frame: Within 7 days (Days 0 - 6) post IP administration
Proportion of unsolicited AE
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AdCLD-CoV19-1 OMI and Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran) in people with COVID-19 and Vaccines, run by Cellid Co., Ltd. at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in South Korea, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At 28 days post IP administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.