Clinical trial NCT05520970: Safety and Immunogenicity of COVID-19 Vaccine, AdCLD-CoV19-1
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Vaccines
Lead sponsor: Cellid Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: International Vaccine Institute
First posted: 2022-08-30
Enrollment: 4
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Healthy individual aged 19 years and above at consent.
2. Individual willing to provide written informed consent to participate study voluntarily.
3. Individuals who can be followed up during the study period and can comply with the study requirements.
4. Individual who agrees not to donate blood during the study participation
5. Females of childbearing potential with negative serum or urinary pregnancy test on the day of screening.
6. 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:

1. Prior SARS-CoV-2 infection confirmed by a rapid antibody kit at screening.
2. History of receiving any vaccine (licensed or investigational) for SARS-CoV-2.
3. History of SARS-CoV-1 or MERS vaccination and treatment.
4. 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.
5. 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.
6. 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.
7. 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).
8. Individual with major congenital abnormalities, which in the opinion of investigator may affect the participant's participation in the study.
9. 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.
10. 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
11. Individual with hereditary or idiopathic angioneurotic edema
12. 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.
13. Individual with splenectomy and transplantation (including solid organ and bone marrow).
14. Individual with past history of thrombocytopenia and/or thrombosis, myocarditis or pericarditis or any other significant cardiac condition.
15. 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).
16. Receipt of immunoglobulin or blood-derived products in the past 12 weeks or plan to receive during the study period.
17. Body mass index (BMI) ≥ 30 kg/m2.
18. As per Investigator's medical judgement, an individual could be excluded from the study in spite of meeting all inclusion/exclusion criteria mentioned above.
19. Any female participant who is lactating\*, pregnant or planning for pregnancy\*\* during the course of study period.
20. Individual concomitantly enrolled or scheduled to be enrolled in another trial.
21. Individual who is research staff involved with the clinical study or family/household members of research staff.

Primary outcomes:
measure: Proportion of immediate adverse events (AE)
timeFrame: Within 30 minutes post each dose injection
measure: Proportion of solicited local and systemic AE
timeFrame: Within 7 days (Days 0 - 6) post each dose injection
measure: Proportion of unsolicited AE
timeFrame: Within 28 days post each dose injection
measure: Proportion of SAE
timeFrame: Throughout the study end, an average of 14 months (12 months post second dose injection)
measure: Proportion of Adverse Event Of Special Interest (AESI)
timeFrame: Throughout the study duration, an average of 14 months (12 months post second dose injection)
measure: Proportion of Medically-Attended Adverse Events (MAAE)
timeFrame: Throughout the study duration, an average of 14 months (12 months post second dose injection)
measure: Proportion of clinically significant changes in clinical safety laboratory parameters
timeFrame: At 1, 2 and 4 weeks post each dose injection
measure: Geometric Mean Titer of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (Neutralizing antibody)
timeFrame: At 2 weeks post second dose injection
measure: Geometric Mean Fold Rise of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (Neutralizing antibody)
timeFrame: At 2 weeks post second dose injection
measure: 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)
timeFrame: At 2 weeks post second dose injection
measure: GMT of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (ELISA)
timeFrame: At 2 weeks post second dose injection
measure: GMFR of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (ELISA)
timeFrame: At 2 weeks post second dose injection
measure: Proportion of participants achieving seroresponse of 1 and 2 doses of AdCLD-CoV19-1 from baseline to 2 weeks post second dose injection (ELISA)
timeFrame: At 2 weeks post second dose injection
Secondary outcomes:
measure: 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)
timeFrame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
measure: 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)
timeFrame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
measure: 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)
timeFrame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
measure: 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)
timeFrame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
measure: 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)
timeFrame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
measure: 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)
timeFrame: At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection
measure: 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)
timeFrame: At 2 weeks, 6 months post first dose injection and 2 weeks, 6 and 12 months post second dose injection
measure: 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)
timeFrame: At 2 weeks, 6 months post first dose injection and 2 weeks, 6 and 12 months post second dose injection
Other outcomes:
measure: Number of virologically-confirmed COVID-19 cases and clinical features in AdCLD-CoV19-1 recipients during the study period
timeFrame: Throughout the study duration, an average of 14 months
measure: 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)
timeFrame: At 2 weeks post second dose injection
measure: 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)
timeFrame: At 2 weeks post second dose injection
measure: 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)
timeFrame: At 2 weeks post second dose injection
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Catholic University Seoul St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References: