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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04666012
Recruitment Status : Active, not recruiting
First Posted : December 14, 2020
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Cellid Co., Ltd.

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

Condition or disease Intervention/treatment Phase
COVID-19 Biological: AdCLD-CoV19 Phase 1 Phase 2

Detailed Description:
Part A is conducted as dose-escalation, single-center, open-label, a Phase 1 clinical trial. Part B is conducted as multi-center, open-label, a Phase 2a clinical trial. In Part A, we assess safety in all dose groups and set suitable two doses for Part B. In Part B, we assess immune responses against SARS-CoV-2 and set suitable dose for next phase of clinical trial. DSMB will evaluate safety during the whole study period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 1/2a Study (Dose Escalation, Single Center, Open, Phase 1 and Multicenter, Open, Phase 2a) to Assess the Safety and Immunogenicity of AdCLD-CoV19: A COVID-19 Preventive Vaccine in Healthy Volunteers
Actual Study Start Date : December 29, 2020
Actual Primary Completion Date : July 9, 2021
Estimated Study Completion Date : April 2022

Arm Intervention/treatment
Experimental: Group 1: low dose
Subject will receive single dose of AdCLD-CoV19(2.5x10^10VP) as intramuscular injection.
Biological: AdCLD-CoV19
Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2.

Experimental: Group 2: middle dose
Subject will receive single dose of AdCLD-CoV19(5.0x10^10VP) as intramuscular injection.
Biological: AdCLD-CoV19
Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2.

Experimental: Group 3: high dose
Subject will receive single dose of AdCLD-CoV19(1.0x10^11VP) as intramuscular injection.
Biological: AdCLD-CoV19
Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2.

Experimental: Group 4: selected dose
Subject will receive single dose of AdCLD-CoV19 as intramuscular injection.
Biological: AdCLD-CoV19
Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2.

Experimental: Group 5: selected dose
Subject will receive single dose of AdCLD-CoV19 as intramuscular injection.
Biological: AdCLD-CoV19
Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2.




Primary Outcome Measures :
  1. Incidence of solicited adverse events(AEs) [ Time Frame: Through 7 days post-vaccination ]
  2. Incidence of unsolicited AEs [ Time Frame: Through 28, 56 days post-vaccination ]

Secondary Outcome Measures :
  1. Incidence of serious adverse events(SAEs) [ Time Frame: Through 12 months post-vaccination ]
  2. Incidence of adverse events of special interest(AESIs) [ Time Frame: Through 12 months post-vaccination ]
  3. Seroconversion rate(SCR) of neutralization antibody using wild type SARS-CoV-2 [ Time Frame: 4, 8 weeks post-vaccination ]
  4. Geometric mean titer(GMT) of neutralization antibody using wild type SARS-CoV-2 [ Time Frame: 4, 8 weeks post-vaccination ]
  5. GMT of S protein specific antibody [ Time Frame: 2, 4, 8, 26, 52 weeks post-vaccination ]
  6. Index of T cell response [ Time Frame: 2, 4, 26, 52 weeks post-vaccination ]

Other Outcome Measures:
  1. SCR of neutralization antibody using pseudovirus [ Time Frame: 2, 4, 8, 26, 52 weeks post-vaccination ]
  2. GMT of neutralization antibody using pseudovirus [ Time Frame: 2, 4, 8, 26, 52 weeks post-vaccination ]
  3. GMT of S protein receptor binding domain(RBD) specific antibody [ Time Frame: 2, 4, 8, 26, 52 weeks post-vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Anyone deemed infected by COVID-19.
  2. Determined to be a close-contact of SARS-CoV-2 confirmed case or classified to symptomatic patient of COVID-19 prior to vaccination.
  3. Clinically significant abnormal ranges of laboratory measurement, ECG, Chest X-ray at screening visit.
  4. Positive in HIV, HBV, HCV test at screening visit.
  5. 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.
  6. Chronic respiratory disease: Asthma, chronic obstructive pulmonary disease, active tuberculosis, latent tuberculosis under treatment.
  7. 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).
  8. Immunosuppressive disease including immunodeficiency disease.
  9. Scheduled to undergo any surgery during the whole study period.
  10. 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.
  11. Prisoners or subjects who are compulsorily detained. (involuntary incarceration)
  12. History of SARS or MERS.
  13. Allergic reaction or hypersensitivity to any ingredient of AdCLD-CoV19.
  14. Having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants.
  15. Any history of malignant disease within the past 5 years.
  16. History of hypersensitivity to inoculate vaccine such as Guillain-Barre syndrome.
  17. History of serious adverse reaction or allergic reaction to inoculate vaccine.
  18. Urticaria past 5 years prior to vaccination.
  19. History of hereditary angioneurotic edema or acquired angioneurotic edema.
  20. History of solid organ or bone marrow transplantation.
  21. Suspected or a history of drug or alcohol abuse past 12 month before vaccination.
  22. Receipt of vaccine of SARS-CoV, MERS-CoV, SARS-CoV-2.
  23. Receipt of adenovirus vector based vaccine.
  24. Chronic use of immunosuppressant or immune modifying drug within 6 months prior to vaccination. (use of inhaled, topical, nasal, and ophthalmic corticosteroids are allowed)
  25. Having relied on antipsychotic drugs and narcotic analgesics within 6 months before vaccination or difficult to comply with the clinical trial procedure at the judgment of the investigator.
  26. Administered to other investigational product or medical device within 6 months before vaccination.
  27. Other vaccination history within 30 days prior to vaccination or being scheduled within 30 days after vaccination.
  28. Receipt of immunoglobulin or any blood product within 3 month prior to vaccination.
  29. Pregnant(including positive hCG test at screening visit) or breastfeeding female.
  30. Current smoker or vaper. (use of cigarette or e-cigarette at least once in last 30 days, Part A only)
  31. Those who are directly related to the investigator.
  32. Other condition deemed ineligible for the study at the discretion of investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666012


Locations
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Korea, Republic of
Korea University Ansan Hospital
Ansan, Province, Korea, Republic of
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, Province, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
Seoul, State, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, State, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Cellid Co., Ltd.
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Responsible Party: Cellid Co., Ltd.
ClinicalTrials.gov Identifier: NCT04666012    
Other Study ID Numbers: AdCLD-CoV19-001
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases