NCT02692170已完成1 期
A Single Center, Randomized, Double Blinded PhaseI/IIa Exploratory Study to Evaluate Reactogenicity, Safety, Immunogenicity and Dose Response of a New Hepatitis B Vaccine in Human Adult
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Safety and reactogenicity (including incidence of adverse events and expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination
研究概览
简要总结
A single center, randomized, double blinded phase I/IIa exploratory study to evaluate reactogenicity, safety, immunogenicity and dose-response of a new hepatitis B vaccine in human adult
详细描述
- Objectives: To explore the most effective dose of the third generation Hepatitis B vaccine through the evaluation of reactogenicity, safety, and immunogenicity.
- Subjects: Adults having anti-HBs antibody titers less than 10 mIU/mL after 3 previous injections of the conventional Hepatitis B vaccine.
- Study hypothesis: The third generation Hepatitis B vaccine, containing preS antigens in addition to S antigen, has an ability to elicit faster protection and higher antibody titers than the second generation Hepatitis B vaccine in the subjects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between 20 and 50 years of age
- •Anti-HBs titers < 10 mIU/mL
- •Subject is able to provide written informed consent by oneself or legal representative
排除标准
- •Hepatitis B core antibodies positive patient
- •Patient has abnormal results in liver-function test
- •Patient has active microbial, viral, or fungal infections in need of systemic treatment
- •Patient has history of serious heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, treatment required ventricular tachyarrhythmias, or unstable angina etc.)
- •Patient has seizure disorder required anticonvulsants treatment
- •Serious chronic obstructive pulmonary disease patient accompanied hypoxemia
- •Uncontrollable diabetic patient
- •Uncontrollable hypertension patient
- •Patient with known history of HIV, HBV, or HCV infection
- •Subject had experience of participating other clinical study or clinical treatment within 30 days before screening
- •Subject has hypersensitivity or anaphylactic reaction for HBV vaccine components
- •Patient being treated for prolonged immunosuppressive therapy (including steroids)
- •Hemodialysis patient
- •Subject has continuous drinking (>21 units/week, 1 unit = 10g of pure alcohol) or dependence on alcohol
- •Subject is pregnant or breastfeeding or intending to become pregnant during the study
- •Subject has any other significant findings unacceptable in this study under the opinion of the investigator
研究组 & 干预措施
CVI-HBV-001 (20 μg)
Experimental
- HBV surface antigen 20 μg/dose
- Intramuscular injection at 0, 1, 6th month
干预措施: CVI-HBV-001 (Biological)
Conventional Hepatitis B vaccine (20 μg)
Active Comparator
- HBV surface antigen 20 μg/dose
- Intramuscular injection at 0, 1, 6th month
干预措施: Conventional Hepatitis B vaccine (20 μg) (Biological)
CVI-HBV-001 (40 μg)
Experimental
- HBV surface antigen 40 μg/dose
- Intramuscular injection at 0, 1, 6th month
干预措施: CVI-HBV-001 (Biological)
CVI-HBV-001 (5 μg)
Experimental
- HBV surface antigen 5 μg/dose
- Intramuscular injection at 0, 1, 6th month
干预措施: CVI-HBV-001 (Biological)
CVI-HBV-001 (10 μg)
Experimental
- HBV surface antigen 10 μg/dose
- Intramuscular injection at 0, 1, 6th month
干预措施: CVI-HBV-001 (Biological)
结局指标
主要结局
Safety and reactogenicity (including incidence of adverse events and expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination
时间窗: 7 days after each vaccination
Occurrence of severe local and/or systemic reactogenicity signs and symptoms measured for 7 days after each vaccination
次要结局
- Seroprotection rate(4 weeks after vaccination)
- Antibody titers to HBsAg(4 weeks after vaccination)
研究者
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