COVID-19Phase 2NCT05520970
Safety and Immunogenicity of COVID-19 Vaccine, AdCLD-CoV19-1
A Phase 2 study testing AdCLD-CoV19-1 in people with COVID-19 and Vaccines, run by Cellid Co., Ltd. at 4 sites in South Korea.
Trial summary
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. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 19 Aug 2022to 8 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy individual aged 19 years and above at consent.
- Individual willing to provide written informed consent to participate study voluntarily.
- Individuals who can be followed up during the study period and can comply with the study requirements.
- Individual who agrees not to donate blood during the study participation
- Females of childbearing potential with negative serum or urinary pregnancy test on the day of screening.
- Females of childbearing potential who are using an effective birth control method for at least 4 weeks before the screening and during the study participation.
Who cannot join
- Prior SARS-CoV-2 infection confirmed by a rapid antibody kit at screening.
- History of receiving any vaccine (licensed or investigational) for SARS-CoV-2.
- History of SARS-CoV-1 or MERS vaccination and treatment.
- Individual determined to be clinically significantly abnormal by the screening outcome based on medical history, physical examination, laboratory evaluations (positive serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, and Human Immunodeficiency Virus (HIV) antibody), electrocardiogram (ECG) and Chest X-ray, and the clinical judgment of the investigator.
- Individual who has received other vaccines from 4 weeks prior to the first dose of test vaccination or planned to receive any vaccine within 4 weeks of the last dose of the study vaccine.
- Febrile illness (tympanic temperature ≥ 38°C) or acute illness with any clinically significant, respiratory symptoms (e.g., sore throat, cough, sputum) within 3 days prior to the study vaccination.
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- Known history or allergy to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial (e.g., Guillain-Barre Syndrome).
- Individual with major congenital abnormalities, which in the opinion of investigator may affect the participant's participation in the study.
- Chronic use of systemic steroids (>10 mg/day prednisone equivalent for periods exceeding 14 days), cytotoxic or other immunosuppressive drugs within the past 6 weeks.
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental to the safety of the participant and interfere with the assessment of the study objectives.
- ① Respiratory diseases: Asthma, Chronic Obstructive Lung Disease (COPD), active or latent tuberculosis which require medication, etc.
- ② Serious cardiovascular diseases: Congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, myocarditis, pericarditis, etc.
- ③ Neurologic diseases: Epilepsy, seizure within 3 years, migraine, stroke, encephalopathy, Guillain-Barre Syndrome, encephalomyelitis, acute transverse myelitis, etc.
- ④ Malignant cancer diagnosed within the past 5 years (skin basal cell and squamous cell carcinoma are excluded).
- ⑤ Immune function disorders, including auto-immune diseases and immunodeficiency diseases (known HIV infection or other immune function disorders)
- ⑥ Other hepatobiliary, renal, endocrine, urinary tract, muscular skeletal diseases which the investigator considers clinically significant
- Individual with hereditary or idiopathic angioneurotic edema
- Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial.
- Individual with splenectomy and transplantation (including solid organ and bone marrow).
- Individual with past history of thrombocytopenia and/or thrombosis, myocarditis or pericarditis or any other significant cardiac condition.
- Individual with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections/blood extractions (Those who receive low dose aspirin (less than 100mg/day) are not excluded).
- Receipt of immunoglobulin or blood-derived products in the past 12 weeks or plan to receive during the study period.
- Body mass index (BMI) ≥ 30 kg/m2.
- As per Investigator's medical judgement, an individual could be excluded from the study in spite of meeting all inclusion/exclusion criteria mentioned above.
- Any female participant who is lactating*, pregnant or planning for pregnancy** during the course of study period.
- Individual concomitantly enrolled or scheduled to be enrolled in another trial.
- Individual who is research staff involved with the clinical study or family/household members of research staff.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Korea University Ansan Hospital
Ansan, 15355
Catholic University Seoul St.Mary's Hospital
Seoul, 06591
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Korea University Guro Hospital
Seoul, 08308
About this study
Official title: A Phase IIb, Multicenter, Observer-Blinded, Randomized, Placebo-Controlled Trial to Evaluate the Immunogenicity and Safety of the AdCLD-CoV19-1 in Healthy Adults Aged 19 Years Old and Above
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.
- Being tested
- AdCLD-CoV19-1
- 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-CoV19-1Biological
All 200 participants will receive 2 doses of investigational product by 2 months interval via intramuscular injection in the deltoid region
| Study group | Role | What they receive |
|---|---|---|
| 2 doses of AdCLD-CoV19-1 | Experimental | Group 1 will receive 2 doses of AdCLD-CoV19-1 Receives: Biological: AdCLD-CoV19-1 |
| 1 dose of AdCLD-CoV19-1 | Experimental | Group 2 will receive 1 doses of AdCLD-CoV19-1 followed by 1 dose of placebo Receives: Biological: AdCLD-CoV19-1 |
| Placebo | Placebo comparator | Group 2 will receive 1 doses of placebo followed by 1 dose of AdCLD-CoV19-1 after an interim analysis Receives: Biological: AdCLD-CoV19-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of immediate adverse events (AE)
- Proportion of immediate AE within 30 minutes post each dose injection
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 2 weeks post second dose injection
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 2 weeks, 6 months post first dose injection and 2 weeks, 6 and 12 months post second dose injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start19 Aug 2022
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Why it stopped: Study early terminated based on the sponsor(manufacture)'s decision
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellid Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Vaccine Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520970
- Sponsor's protocol ID
- IVI-AdCLD-CoV19-1
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2022
- Last updated
- 22 Jun 2023
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Multicenter, Observer-Blinded, Randomized, Placebo-Controlled Trial to Evaluate the Immunogenicity and Safety of the AdCLD-CoV19-1 in Healthy Adults Aged 19 Years Old and Above
- ClinicalTrials.gov ID
- NCT05520970
- Acronym / sponsor ID
- IVI-AdCLD-CoV19-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study early terminated based on the sponsor(manufacture)'s decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cellid Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- International Vaccine Institute
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 30 Aug 2022 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 doses of AdCLD-CoV19-1 | Experimental | Biological: AdCLD-CoV19-1Group 1 will receive 2 doses of AdCLD-CoV19-1 |
| 1 dose of AdCLD-CoV19-1 | Experimental | Biological: AdCLD-CoV19-1Group 2 will receive 1 doses of AdCLD-CoV19-1 followed by 1 dose of placebo |
| Placebo | Placebo comparator | Biological: AdCLD-CoV19-1Group 2 will receive 1 doses of placebo followed by 1 dose of AdCLD-CoV19-1 after an interim analysis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy individual aged 19 years and above at consent.
- Individual willing to provide written informed consent to participate study voluntarily.
- Individuals who can be followed up during the study period and can comply with the study requirements.
- Individual who agrees not to donate blood during the study participation
- Females of childbearing potential with negative serum or urinary pregnancy test on the day of screening.
Key exclusion criteria (27 listed)
- Prior SARS-CoV-2 infection confirmed by a rapid antibody kit at screening.
- History of receiving any vaccine (licensed or investigational) for SARS-CoV-2.
- History of SARS-CoV-1 or MERS vaccination and treatment.
- Individual determined to be clinically significantly abnormal by the screening outcome based on medical history, physical examination, laboratory evaluations (positive serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, and Human Immunodeficiency Virus (HIV) antibody), electrocardiogram (ECG) and Chest X-ray, and the clinical judgment of the investigator.
- Individual who has received other vaccines from 4 weeks prior to the first dose of test vaccination or planned to receive any vaccine within 4 weeks of the last dose of the study vaccine.
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-CoV19-1All 200 participants will receive 2 doses of investigational product by 2 months interval via intramuscular injection in the deltoid region | Biological | 1 dose of AdCLD-CoV19-1, 2 doses of AdCLD-CoV19-1, Placebo |
Primary outcome
Proportion of immediate adverse events (AE)
Time frame: Within 30 minutes post each dose injection
• Proportion of immediate AE within 30 minutes post each dose injection
Proportion of solicited local and systemic AE
Time frame: Within 7 days (Days 0 - 6) post each dose injection
• 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.
Proportion of unsolicited AE
Time frame: Within 28 days post each dose injection
• 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).
Proportion of SAE
Time frame: Throughout the study end, an average of 14 months (12 months post second dose injection)
• 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.
Proportion of Adverse Event Of Special Interest (AESI)
Time frame: Throughout the study duration, an average of 14 months (12 months post second dose injection)
• 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).
Proportion of Medically-Attended Adverse Events (MAAE)
Time frame: Throughout the study duration, an average of 14 months (12 months post second dose injection)
• 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.
Proportion of clinically significant changes in clinical safety laboratory parameters
Time frame: At 1, 2 and 4 weeks post each dose injection
Proportion of clinically significant changes in clinical safety laboratory parameters 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)
Time frame: At 2 weeks post second dose injection
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
Geometric Mean Fold Rise of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (Neutralizing antibody)
Time frame: At 2 weeks post second dose injection
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
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)
Time frame: At 2 weeks post second dose injection
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
GMT of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (ELISA)
Time frame: At 2 weeks post second dose injection
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
GMFR of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (ELISA)
Time frame: At 2 weeks post second dose injection
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
Proportion of participants achieving seroresponse of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (ELISA)
Time frame: At 2 weeks post second dose injection
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
8 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
Time frame: At 2 weeks, 6 months post first dose injection and 2 weeks, 6 and 12 months post second dose injection
Results and safety
The study was stopped early (reason given: Study early terminated based on the sponsor(manufacture)'s decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AdCLD-CoV19-1 in people with COVID-19 and Vaccines, run by Cellid Co., Ltd. at 4 sites in South Korea.
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 27 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: stopped early, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study early terminated based on the sponsor(manufacture)'s decision). Results are not available in the source record.
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?
Proportion of immediate adverse events (AE) (time frame: Within 30 minutes post each dose injection). The study lists 13 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 22 Jun 2023.