Safety and Immunogenicity of AdCLD-CoV19-1 OMI as a Booster: A SARS-CoV-2 (COVID-19) Preventive Vaccine

NCT05576623 | Completed Phase 1 DMC

• 1 other identifier: COVENT-201
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 7

Brief Summary

The safety and immunogenicity 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.

Conditions

COVID-19; Vaccines

Keywords

COVID-19; SARS-CoV-2; Omicron; B.1.1.529

Outcome Measures

Primary Outcomes (10)

• Proportion of immediate adverse events (AE)

  Proportion of immediate AE within 30 minutes post dose injection.

  Within 30 minutes post dose injection

• Proportion of solicited local and systemic AE

  Proportion of solicited local and systemic AEs within 7 days post 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 dose injection

• Proportion of unsolicited AE

  Proportion of unsolicited AEs within 28 days post dose injection. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited AEs).

  Within 28 days post dose injection

• Proportion of SAE

  Proportion of any SAE from the administration throughout the entire study. An AE or suspected adverse reaction is considered "serious": 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 duration, 12 months post dose injection

• Proportion of Adverse Event Of Special Interest (AESI)

  Proportion of any AESI from the administration 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, 12 months post dose injection

• Proportion of Medically-Attended Adverse Events (MAAE)

  Proportion of any MAAE from the administration 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, 12 months post dose injection

• Proportion of clinically significant changes in clinical safety laboratory parameters

  Proportion of clinically significant changes in clinical safety laboratory parameters at 7, 14, 28 days post dose injection.

  At 7, 14, 28 days post dose injection

• Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody)

  Proportion of participants achieving seroresponse (SR defined as at least 2-fold increase from baseline) of wild-type virus neutralizing antibody titer from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.

  At 2, 4 weeks post dose injection

• Geometric Mean Titer of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody)

  Geometric Mean Titer (GMT) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.

  At 2, 4 weeks post dose injection

• Geometric Mean Fold Rise of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody)

  Geometric Mean Fold Rise (GMFR) of neutralizing antibody to the SARS-CoV-2 B.1.1.529 measured by wild-type virus neutralization assay from baseline to 2, 4 weeks post dose injection induced by 1 dose of AdCLD-CoV19-1 OMI.

  At 2, 4 weeks post dose injection

Secondary Outcomes (8)

• Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody)

  At 12, 26, 52 weeks post dose injection

• Geometric Mean Titer of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody)

  At 12, 26, 52 weeks post dose injection

• Geometric Mean Fold Rise of 1 dose of AdCLD-CoV19-1 OMI from baseline to 12, 26, 52 weeks post dose injection (Neutralizing antibody)

  At 12, 26, 52 weeks post dose injection

• Proportion of participants achieving seroresponse of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4, 12, 26, 52 weeks post dose injection (ELISA)

  At 2, 4, 12, 26, 52 weeks post dose injection

• GMT of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4, 12, 26, 52 weeks post dose injection (ELISA)

  At 2, 4, 12, 26, 52 weeks post dose injection

Other Outcomes (6)

• SRR, GMT, GMFR of 1 dose of AdCLD-CoV19-1 OMI from baseline to 4 weeks post dose injection (Neutralizing antibody)

  At 4 weeks post dose injection

• SRR, GMT, GMFR of 1 dose of AdCLD-CoV19-1 OMI from baseline to 2, 4 weeks post dose injection (Neutralizing antibody) according to the recipients features.

  At 2, 4 weeks post dose injection

• Number of virologically-confirmed COVID-19 cases from 2 weeks post dose injection to the end of study period

  Throughout the study duration, 12 months post dose injection

Study Arms (3)

1 dose of AdCLD-CoV19-1 OMI (Part A)

EXPERIMENTAL

Group in Part A will receive 1 dose of AdCLD-CoV19-1 OMI

Biological: AdCLD-CoV19-1 OMI (Part A)

1 dose of AdCLD-CoV19-1 OMI (Part B)

EXPERIMENTAL

Group 1 in Part B will receive 1 dose of AdCLD-CoV19-1 OMI

Biological: AdCLD-CoV19-1 OMI (Part B)

Placebo (Part B)

PLACEBO COMPARATOR

Group 2 in Part B will receive 1 dose of placebo

Other: Placebo (Part B)

Interventions

AdCLD-CoV19-1 OMI (Part A) BIOLOGICAL

20 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle

1 dose of AdCLD-CoV19-1 OMI (Part A)

AdCLD-CoV19-1 OMI (Part B) BIOLOGICAL

250 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle

1 dose of AdCLD-CoV19-1 OMI (Part B)

Placebo (Part B) OTHER

50 participants will receive placebo via intramuscular injection in the deltoid muscle

Placebo (Part B)

Eligibility Criteria

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

You may qualify if:

• (Part A) Individual aged between 19-64 years old and willing to provide written informed consent to participate study voluntarily.
• (Part B) Individual aged 19 years and above and willing to provide written informed consent to participate study voluntarily.
• Individual fall under one or more of the following;
• Those who have been at least 16 weeks (112 days) and less than 48 weeks (336 days) without additional COVID-19 vaccination since the last COVID-19 vaccination.
• Those who have been at least 16 weeks (112 days) or more and less than 48 weeks (336 days) since the release of quarantine due to COVID-19 confirmation.
• Individual with body mass index (BMI) of 30.0 kg/m2 or less at screening visit.
• Individual who agrees with using an effective birth control method for at least 4 weeks before the screening and during the study period.
• Individual who agrees not to donate or transfuse blood (including whole blood, plasma components, platelet components, and platelet plasma components) during the study period.

You may not qualify if:

• Individual who has history of COVID-19 or is considered infected within 16 weeks (112 days) prior to administration of investigational product.
• Individual who has received other COVID-19 vaccine within 16 weeks (112 days) prior to administration of investigational product.
• Individual who has been in close contact with a COVID-19 infected person, or has been classified as a confirmed or suspected COVID-19 patient within 14 days prior to administration of investigational product.
• Individual determined to be clinically significantly abnormal by the screening outcome based on laboratory evaluations, electrocardiogram (ECG) and Chest X-ray.
• Individual who has ant results of positive to HIV test, hepatitis B test, and hepatitis C test on screening.
• Acute febrile illness with 38°C and above, or any suspected infectious diseases, or symptoms similar to COVID-19 (cough, shortness of breathe, chills, myalgia, headache, sore throat, loss of taste/smell, etc.) within 3 days prior to administration of investigational product.
• Any serious medical or psychiatric disease which in opinion of investigator judges unable to participate
• Respiratory diseases: Asthma, Chronic Obstructive Lung Disease (COPD), active or latent tuberculosis which require medication, or individual who has received treatment due to worsening of the respiratory disease within 5 years prior to administration of investigational product.
• Serious cardiovascular diseases: Congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, myocarditis, pericarditis, etc.
• Neurologic diseases: Epilepsy, seizure within 3 years, migraine, stroke, encephalopathy, Guillain-Barre Syndrome, encephalomyelitis, acute transverse myelitis, etc.
• Malignant cancer diagnosed within the past 5 years (skin basal cell and squamous cell carcinoma are excluded).
• Immune function disorders including autoimmune hypothyroidism, psoriasis.
• Auto-immune diseases.
• History of dependently administering psychotropic drugs or narcotic painkillers within 24 weeks prior to administration of investigational product, or psychiatric disease or behavioral impairment that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial.
• Other hepatobiliary, renal, endocrine, urinary tract, muscular skeletal diseases which the investigator considers clinically significant.

Sponsors & Collaborators

• Cellid Co., Ltd.: lead

Study Sites (7)

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, South Korea

Location

The Catholic University of Korea ST. Vincent's Hospital

Gyeonggi-do, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

COVID-19

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 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 12, 2022
• Study Start: September 14, 2022
• Primary Completion: March 10, 2023
• Study Completion: February 28, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7)