A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Prophylactic Hepatitis B Vaccine

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-HBV-002.

Detailed Description
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A Randomized, Open-labelled, Parallel, Phase 1 clinical study to evaluate the safety, reactogenicity and immunogenicity of the hepatitis B vaccine CVI-HBV-002 in adults

Official Title
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A Randomized, Open-labelled, Parallel, Phase 1 Clinical Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Hepatitis B Vaccine CVI-HBV-002 in Adults

Conditions
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Vaccine-Preventable Diseases, Hepatitis B

Intervention / Treatment
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* Biological: CVI-HBV-002


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any gender, age 19-64 years Those whose anti-HBs titer is less than 10 mIU/mL Those who have voluntarily agreed to participate in this clinical trial and signed the subject consent form Exclusion Criteria: Patient with positive test for antibody to hepatitis B core antigen (anti-HBc) Acute illness and/or fever (tympanic temperature rises greater than 38 degrees Celsius) within 72 hours before administration of investigational product A person who suffered from serious acute or chronic infection within 7 days prior to administration of investigational product (Those who need systemic antibiotic treatment or antiviral therapy) In case of immunodeficiency or immune dysfunction, or if there is a family history of such Patients with abnormal liver function test results Patients with active bacterial, viral or fungal infections requiring systemic treatment Patients with a history of serious heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring treatment, or unstable angina, etc.) Seizure disorders requiring anticonvulsant treatment Patients with severe chronic obstructive pulmonary disease accompanied by hypoxemia Patients with uncontrolled diabetes Patients with uncontrolled hypertension Patient with positive test for HBsAg, HIV or Hepatitis C Those with hypersensitivity or anaphylactic reaction to HBV vaccine components Those who have received immunosuppressive or immunomodulatory drugs within 6 months before screening Patients who have received high-dose (20 mg or more per day based on prednisolone*) systemic corticosteroids for a long period of time (administration for more than 14 consecutive days) within 3 months before screening (in the case of topical corticosteroids, subject to the investigator's judgment) * Equivalent to cortisone 125 mg, hydrocortisone 100 mg, prednisone 20 mg, methylprednisolone 16 mg, triamcinolone 16 mg, dexamethasone 3 mg, betamethasone 2.4 mg Patients currently undergoing hemodialysis In case of continuous drinking (more than 21 units/week, 1 unit (1 cup) = 10g of pure alcohol) or alcohol dependence In addition to the above, those who have clinically significant findings that are considered inappropriate for this study based on medical judgment by the principal investigator or person in charge Pregnant or lactating women or self- and partner contraception during clinical trials (e.g., sterilization, intrauterine contraceptives, oral contraceptives in combination with interstitial barrier contraception, other hormone delivery systems in combination with interstitial barrier contraception, contraceptive cream, jelly or foam) Persons who cannot agree on diaphragms or condoms) Patients who are concerned about the decline in daily function due to mental illness or who cannot understand the purpose and method of this clinical trial Those who may show other serious febrile or systemic reactions Those who are scheduled to participate in other clinical trials after being enrolled in this clinical trial, or who have participated in other clinical trials within 3 months before being enrolled in this clinical trial Those who are considered difficult to conduct this clinical trial when judged by other investigators

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 8 / total 3 doses | Biological: CVI-HBV-002<br>* Investigational Product<br>|
| Experimental: Group 2<br>CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 24 / total 3 doses | Biological: CVI-HBV-002<br>* Investigational Product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate adverse events | Occurrence of immediate adverse events | within 30 minutes post vaccination timepoint | 
| Solicited local and systemic signs and symptoms | Occurrence, severity, and duration of solicited local injection site reactions for 7 days (Day 0-Day 6) following each vaccination. (e.g., pain in daily activities, redness and swelling in size(cm)) Occurrence, severity, and duration of solicited systemic reactions for 7 days (Day 0-Day 6) following each vaccination. (e.g., myalgia, fatigue and headache in daily activities, fever in oral temperature) | Time Frame: Day 0 - Day 6 post each vaccination timepoint | 
| Unsolicited signs and symptoms | Occurrence, severity, and relationship to vaccination of unsolicited adverse events until 28 days following each vaccination | Day 0-Day 28 post each vaccination timepoint | 
| SAEs | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity | Up to Week 48 post the 3rd vaccination | 
| Safety as measured by clinical laboratory test, vial sign and physical examination parameters | Occurrence, intensity, and relationship to vaccination of clinically significant adverse events | Until Week 48 post the 3rd vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotective Immune Response | Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at baseline and at Weeks 4 post each vaccination and at last visit | Baseline, Weeks 4, 8, 12 and 56 for Group 1, baseline, Weeks 4, 8, 28 and 72 for Group 2 | 
| Measurement of Serum GMT | Serum GMT of Anti-HBsAg Measured at baseline and at Weeks 4 post each vaccination and at last visit | Weeks 4, 8, 12 and 56 for Group 1, Weeks 4, 8, 28 and 72 for Group 2 |