Safety and Immunogenicity of COVID-19 Vaccine, AdCLD-CoV19-1

NCT05520970 | Terminated Phase 2 DMC

• 1 other identifier: IVI-AdCLD-CoV19-1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19; Vaccines

Outcome Measures

Primary Outcomes (13)

• Proportion of immediate adverse events (AE)

  • Proportion of immediate AE within 30 minutes post each dose injection

  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.

  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).

  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.

  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).

  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.

  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

  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

  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

  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

  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

  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

  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

  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)

  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)

  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)

  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)

  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)

  At 1, 3, 6 months post first dose injection and at 1, 3, 6 and 12 months post second dose injection

Other Outcomes (4)

• Number of virologically-confirmed COVID-19 cases and clinical features in AdCLD-CoV19-1 recipients during the study period

  Throughout the study duration, an average of 14 months

• 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)

  At 2 weeks post second dose injection

• 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)

  At 2 weeks post second dose injection

Study Arms (3)

2 doses of AdCLD-CoV19-1

EXPERIMENTAL

Group 1 will receive 2 doses of AdCLD-CoV19-1

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

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

Biological: AdCLD-CoV19-1

Interventions

AdCLD-CoV19-1 BIOLOGICAL

All 200 participants will receive 2 doses of investigational product by 2 months interval via intramuscular injection in the deltoid region

1 dose of AdCLD-CoV19-1; 2 doses of AdCLD-CoV19-1; Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cellid Co., Ltd.: lead
• International Vaccine Institute: collaborator

Study Sites (4)

Korea University Ansan Hospital

Ansan, 15355, South Korea

Location

Catholic University Seoul St.Mary's Hospital

Seoul, 06591, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

AdCLD-CoV19-1 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is designed as observer-blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: August 30, 2022
• Study Start: August 19, 2022
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)