Hepatitis B, Vaccine-Preventable Diseases
Conditions
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
Interventions
BIOLOGICALCVI-HBV-002
Investigational Product
Sponsors
CHA Vaccine Institute Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Any gender, age 19-64 years 2. Those whose anti-HBs titer is less than 10 mIU/mL 3. Those who have voluntarily agreed to participate in this clinical trial and signed the subject consent form
Exclusion criteria
1. Patient with positive test for antibody to hepatitis B core antigen (anti-HBc) 2. Acute illness and/or fever (tympanic temperature rises greater than 38 degrees Celsius) within 72 hours before administration of investigational product 3. 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) 4. In case of immunodeficiency or immune dysfunction, or if there is a family history of such 5. Patients with abnormal liver function test results 6. Patients with active bacterial, viral or fungal infections requiring systemic treatment 7. 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.) 8. Seizure disorders requiring anticonvulsant treatment 9. Patients with severe chronic obstructive pulmonary disease accompanied by hypoxemia 10. Patients with uncontrolled diabetes 11. Patients with uncontrolled hypertension 12. Patient with positive test for HBsAg, HIV or Hepatitis C 13. Those with hypersensitivity or anaphylactic reaction to HBV vaccine components 14. Those who have received immunosuppressive or immunomodulatory drugs within 6 months before screening 15. 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 16. Patients currently undergoing hemodialysis 17. In case of continuous drinking (more than 21 units/week, 1 unit (1 cup) = 10g of pure alcohol) or alcohol dependence 18. 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 19. 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) 20. 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 21. Those who may show other serious febrile or systemic reactions 22. 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 23. Those who are considered difficult to conduct this clinical trial when judged by other investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solicited local and systemic signs and symptoms | 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) |
| SAEs | 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 |
| Safety as measured by clinical laboratory test, vial sign and physical examination parameters | Until Week 48 post the 3rd vaccination | Occurrence, intensity, and relationship to vaccination of clinically significant adverse events |
| Immediate adverse events | within 30 minutes post vaccination timepoint | Occurrence of immediate adverse events |
| Unsolicited signs and symptoms | Day 0-Day 28 post each vaccination timepoint | Occurrence, severity, and relationship to vaccination of unsolicited adverse events until 28 days following each vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Serum GMT | Weeks 4, 8, 12 and 56 for Group 1, Weeks 4, 8, 28 and 72 for Group 2 | Serum GMT of Anti-HBsAg Measured at baseline and at Weeks 4 post each vaccination and at last visit |
| Seroprotective Immune Response | Baseline, Weeks 4, 8, 12 and 56 for Group 1, baseline, Weeks 4, 8, 28 and 72 for Group 2 | 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 |
Countries
South Korea
Outcome results
None listed