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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Vaccine-Preventable Diseases
- Sponsor
- CHA Vaccine Institute Co., Ltd.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Immediate adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-HBV-002.
Detailed Description
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Immediate adverse events
Time Frame: within 30 minutes post vaccination timepoint
Occurrence of immediate adverse events
Unsolicited signs and symptoms
Time Frame: Day 0-Day 28 post each vaccination timepoint
Occurrence, severity, and relationship to vaccination of unsolicited adverse events until 28 days following each vaccination
SAEs
Time Frame: Up to Week 48 post the 3rd vaccination
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
Solicited local and systemic signs and symptoms
Time Frame: Time Frame: Day 0 - Day 6 post each vaccination timepoint
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)
Safety as measured by clinical laboratory test, vial sign and physical examination parameters
Time Frame: Until Week 48 post the 3rd vaccination
Occurrence, intensity, and relationship to vaccination of clinically significant adverse events
Secondary Outcomes
- Measurement of Serum GMT(Weeks 4, 8, 12 and 56 for Group 1, Weeks 4, 8, 28 and 72 for Group 2)
- Seroprotective Immune Response(Baseline, Weeks 4, 8, 12 and 56 for Group 1, baseline, Weeks 4, 8, 28 and 72 for Group 2)