The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-HBV-002.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Investigational Product
CHA University Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Immediate adverse events
Occurrence of immediate adverse events
Time frame: 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: 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
Time frame: 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
Time frame: 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
Time frame: Until Week 48 post the 3rd vaccination
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: Weeks 4, 8, 12 and 56 for Group 1, Weeks 4, 8, 28 and 72 for Group 2