Safety and Immunogenicity Study of AdCLD-CoV19: A COVID-19 Preventive Vaccine in Healthy Volunteers

NCT04666012 | Completed Phase 1 DMC

• 1 other identifier: AdCLD-CoV19-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

This is a Phase 1/2a clinical trial to assess the safety and immunogenicity of AdCLD-CoV19 in healthy adults.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Incidence of solicited adverse events(AEs)

  Through 7 days post-vaccination

• Incidence of unsolicited AEs

  Through 28, 56 days post-vaccination

Secondary Outcomes (6)

• Incidence of serious adverse events(SAEs)

  Through 12 months post-vaccination

• Incidence of adverse events of special interest(AESIs)

  Through 12 months post-vaccination

• Seroconversion rate(SCR) of neutralization antibody using wild type SARS-CoV-2

  4, 8 weeks post-vaccination

• Geometric mean titer(GMT) of neutralization antibody using wild type SARS-CoV-2

  4, 8 weeks post-vaccination

• GMT of S protein specific antibody

  2, 4, 8, 26, 52 weeks post-vaccination

Other Outcomes (3)

• SCR of neutralization antibody using pseudovirus

  2, 4, 8, 26, 52 weeks post-vaccination

• GMT of neutralization antibody using pseudovirus

  2, 4, 8, 26, 52 weeks post-vaccination

• GMT of S protein receptor binding domain(RBD) specific antibody

  2, 4, 8, 26, 52 weeks post-vaccination

Study Arms (5)

Group 1: low dose

EXPERIMENTAL

Subject will receive single dose of AdCLD-CoV19(2.5x10\^10VP) as intramuscular injection.

Biological: AdCLD-CoV19

Group 2: middle dose

EXPERIMENTAL

Subject will receive single dose of AdCLD-CoV19(5.0x10\^10VP) as intramuscular injection.

Biological: AdCLD-CoV19

Group 3: high dose

EXPERIMENTAL

Subject will receive single dose of AdCLD-CoV19(1.0x10\^11VP) as intramuscular injection.

Biological: AdCLD-CoV19

Group 4: selected dose

EXPERIMENTAL

Subject will receive single dose of AdCLD-CoV19 as intramuscular injection.

Biological: AdCLD-CoV19

Group 5: selected dose

EXPERIMENTAL

Subject will receive single dose of AdCLD-CoV19 as intramuscular injection.

Biological: AdCLD-CoV19

Interventions

AdCLD-CoV19 BIOLOGICAL

Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2.

Group 1: low dose; Group 2: middle dose; Group 3: high dose; Group 4: selected dose; Group 5: selected dose

Eligibility Criteria

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

You may qualify if:

• Able and willing to agree informed consent and aged 19 to 64 years.
• The BMI index is 18.5 kg/m2 to 30.0 kg/m2.
• Weigh 40kg to 100kg (Part A only)
• Able and willing to medically effective contraception during the whole study period.
• Agreement to refrain from blood donation during the whole study period.

You may not qualify if:

• Anyone deemed infected by COVID-19.
• Determined to be a close-contact of SARS-CoV-2 confirmed case or classified to symptomatic patient of COVID-19 prior to vaccination.
• Clinically significant abnormal ranges of laboratory measurement, ECG, Chest X-ray at screening visit.
• Positive in HIV, HBV, HCV test at screening visit.
• Acute fever(≥ 38℃) or suspected infectious disease, symptoms of infectious disease(cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste, etc.) within 3 days prior to vaccination.
• Chronic respiratory disease: Asthma, chronic obstructive pulmonary disease, active tuberculosis, latent tuberculosis under treatment.
• Clinically significant active or any history of disease: Hepatobiliary system, kidney, central or peripheral nervous system (epilepsy, seizure, etc.), endocrine system (uncontrolled diabetes, hyperlipidemia, etc.), cardiovascular system (congestive heart failure, coronary artery disease, myocardial infarction, control Hypertension, etc.), blood tumor, urinary system, mental, musculoskeletal system, immune system (rheumatoid arthritis, systemic lupus erythematosus).
• Immunosuppressive disease including immunodeficiency disease.
• Scheduled to undergo any surgery during the whole study period.
• Healthcare worker who provide medical care to SARS-CoV-2 cases or occupationally in high risk for SARS-CoV-2 exposure during the whole study period.
• Prisoners or subjects who are compulsorily detained. (involuntary incarceration)
• History of SARS or MERS.
• Allergic reaction or hypersensitivity to any ingredient of AdCLD-CoV19.
• Having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants.
• Any history of malignant disease within the past 5 years.

Sponsors & Collaborators

• Cellid Co., Ltd.: lead

Study Sites (5)

Korea University Ansan Hospital

Ansan, Province, South Korea

Location

The Catholic University of Korea, ST. Vincent's Hospital

Suwon, Province, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, State, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, State, 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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 14, 2020
• Study Start: December 29, 2020
• Primary Completion: July 9, 2021
• Study Completion: March 27, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

KR (5)