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
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
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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