June 20, 2022
|
August 30, 2022
|
June 22, 2023
|
August 19, 2022
|
November 8, 2022 (Final data collection date for primary outcome measure)
|
- 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
|
Same as current
|
|
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
|
Same as current
|
- Number of virologically-confirmed COVID-19 cases and clinical features in AdCLD-CoV19-1 recipients during the study period [ Time Frame: Throughout the study duration, an average of 14 months ]
- Occurrences of confirmed COVID-19
- Occurrence of symptomatic COVID-19
- Occurrences of hospitalized COVID-19
- Occurrence of severe COVID-19
- Death associated with COVID-19
- Severity of symptoms associated with symptomatic COVID-19 episode
- GMT against the circulating strains, including the variants of concern from baseline to 2 weeks post second dose injection induced by AdCLD-CoV19-1 (Neutralizing antibody) [ Time Frame: At 2 weeks post second dose injection ]
GMT of neutralizing antibody to the circulating strains measured by wild-type virus neutralization assay from baseline to 2 weeks post second dose injection induced by AdCLD-CoV19-1
- GMFR against the circulating strains, including the variants of concern from baseline to 2 weeks post second dose injection induced by AdCLD-CoV19-1 (Neutralizing antibody) [ Time Frame: At 2 weeks post second dose injection ]
GMFR of neutralizing antibody to the circulating strains measured by wild-type virus neutralization assay from baseline to 2 weeks post second dose injection induced by AdCLD-CoV19-1
- Proportion of participants achieving seroresponse against the circulating strains, including the variants of concern from baseline to 2 weeks post second dose injection induced by AdCLD-CoV19-1 (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 AdCLD-CoV19-1
|
Same as current
|
|
Safety and Immunogenicity of COVID-19 Vaccine, AdCLD-CoV19-1
|
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.
|
Not Provided
|
Interventional
|
Phase 2
|
Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: The study is designed as observer-blinded. Primary Purpose: Prevention
|
|
Biological: AdCLD-CoV19-1
All 200 participants will receive 2 doses of investigational product by 2 months interval via intramuscular injection in the deltoid region
|
- Experimental: 2 doses of AdCLD-CoV19-1
Group 1 will receive 2 doses of AdCLD-CoV19-1
Intervention: Biological: AdCLD-CoV19-1
- Experimental: 1 dose of AdCLD-CoV19-1
Group 2 will receive 1 doses of AdCLD-CoV19-1 followed by 1 dose of placebo
Intervention: Biological: AdCLD-CoV19-1
- Placebo Comparator: Placebo
Group 2 will receive 1 doses of placebo followed by 1 dose of AdCLD-CoV19-1 after an interim analysis
Intervention: Biological: AdCLD-CoV19-1
|
Not Provided
|
|
Terminated
|
4
|
200
|
November 8, 2022
|
November 8, 2022 (Final data collection date for primary outcome measure)
|
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
|
Sexes Eligible for Study: |
All |
|
19 Years and older (Adult, Older Adult)
|
Yes
|
Contact information is only displayed when the study is recruiting subjects
|
Korea, Republic of
|
|
|
NCT05520970
|
IVI-AdCLD-CoV19-1
|
Yes
|
Studies a U.S. FDA-regulated Drug Product: |
No |
Studies a U.S. FDA-regulated Device Product: |
No |
|
|
Cellid Co., Ltd.
|
International Vaccine Institute
|
Cellid Co., Ltd.
|
International Vaccine Institute
|
International Vaccine Institute
|
Not Provided
|
Cellid Co., Ltd.
|
June 2023
|