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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Immediate adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-HBV-002.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Immediate adverse events
时间窗: within 30 minutes post vaccination timepoint
Occurrence of immediate adverse events
Unsolicited signs and symptoms
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Until Week 48 post the 3rd vaccination
Occurrence, intensity, and relationship to vaccination of clinically significant adverse events
次要结局
- 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)