Status and phase
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About
This study is to evaluate the safety, reactogenicity, and immunogenicity of the QTP104 vaccine against SARS-CoV-2 infection in healthy adults.
Full description
This study is designed to evaluate the safety, immunogenicity of 3 doses of QTP104. The reason for including 3 doses were to further explore the immunogenicity of these dose levels. This clinical trial is an open label and does not apply to randomized assignment procedures. This study is an open label and does not apply to the maintenance and release procedure of double-blinding. The selection of healthy adults is to confirm the safety of dose-escalation through phase 1 clinical trials.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
[Current disease and medical history]
Subject who has identified any acute, chronic, or clinically significant disease as a result of a physical or laboratory examination during a screening visit (Visit 1)
Subject who has a history of malignant tumors within the past 5 years
Subject who has an immune dysfunction, including immunodeficiency disease, or a family history thereof through a medical history and/or physical examination
Subject who has positive SARS-CoV-2 IgG Ab results during screening visit (Visit 1)
Subject previously diagnosed with COVID-19
Subject with any acute, chronic, or clinically significant disease as a result of physical examination or laboratory examination at the screening visit (Visit 1)
Subject with a history of malignancy within 5 years before the first dose of the investigational drug (except for basal cell and squamous cell carcinoma of the skin)
Subject with immune dysfunction including immunodeficiency disease through medical history and/or physical examination, or with a family history
Subject with a positive result of virus test (hepatitis B test, hepatitis A test, human immunodeficiency virus test, hepatitis C test) at the screening visit (Visit 1)
Subject who are significantly abnormal clinically in laboratory tests, electrocardiogram, chest, and X-rays performed at the screening visit (Visit 1) and those who are judged impossible to participate in the clinical trial at the discretion of the investigator
Subject with a history of hypersensitivity or severe allergic reaction to vaccine administration [e.g. anaphylaxis, Guillain-Barre syndrome, urticaria*, other clinically significant reactions requiring medical intervention]
Urticaria: Those with a history of systemic urticaria within 5 years before administration of investigational drugs
Subject with diseases on such systems as hepatobiliary, kidney, nervous system (central or peripheral), respiratory (asthma, pneumonia, etc.), endocrine (uncontrolled diabetes mellitus, hyperlipidemia, etc.), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension) etc.), urinary, psychiatric, musculoskeletal disorders or have a clinically significant history that it is judged to be unable to participate in a clinical trial under the judgment of the investigator
Subject with autoimmune diseases including autoimmune hypothyroidism and psoriasis
Subject with suspected or history of alcohol or substance abuse 12 months prior to the scheduled screening visit (Visit 1). Alcohol abuse standards are defined as follows:
Subject who has had a serious adverse reaction to a drug containing the same component as the investigational drug or has a history of allergy
Subject who has had a cough, dyspnea, chills, muscle pain, headache, sore throat, loss of smell or taste and an acute fever in which the body temperature exceeds 37.5°C within 72 hours prior to administration of the clinical trial drug
Subject who has been diagnosed with COVID-19 and/or have been confirmed or treated for COVID-19 infection as a result of laboratory tests
Subject with a history of previous MERS-CoV or SARS-CoV infection
Subject with a history of hereditary or idiopathic angioneurotic edema
Subject with a history of organ or bone marrow transplantation
[Relating to contraindicated drugs]
Subject who has experience in administering an immunosuppressant or immune modifying drug within 6 months prior to administration of an investigational drug
Patients with hemophilia who are at risk of serious bleeding when injected intramuscularly or are taking anticoagulants.
Subject who has received immunoglobulin or blood-derived products within 3 months prior to administration of the investigational drug or are expected to administer it during the clinical trial period
Subject who participated in other clinical trials similar to the investigational drug before the screening visit (Visit 1)
Subject with a history of MERS-CoV or SARS-CoV vaccination
Subject who haa received or plan to administer the vaccine within 4 weeks before/after administration of this investigational drug
Subject with a history of platelet-related disease or hemorrhagic disease, a history of severe bleeding or bruising after intramuscular injection or venipuncture or a person taking anticoagulants
If there is a history of dependent administration of psychotropic drugs or narcotic analgesics within 6 months prior to administration of the investigational drug or in case of a mental illness or social condition in which it is difficult to comply with the clinical trial procedure according to the judgment of the investigator
Primary purpose
Allocation
Interventional model
Masking
36 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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