A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,838
- 试验地点
- 26
- 主要终点
- Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1)
研究概览
简要总结
A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
详细描述
The primary objective of the study is to verify that the manufacturing equivalence of Sci-B-Vac™ is consistent and to compare the immunogenicity and safety of a three-dose regimen of Sci-B-Vac™ to a three-dose regimen of Engerix-B® 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any gender
- •Age 18-45 years
- •Healthy, as determined by a physical examination and values of laboratory tests
- •If female, either is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), is of childbearing potential and must agree to use an adequate birth control method
- •Able and willing to give informed consent
排除标准
- •Previous vaccination with any Hep B vaccine (HBV) (licensed or experimental)
- •Treatment by immunosuppressant within 30 days of enrollment
- •History of immunological function impairment
- •Pregnancy or breastfeeding
- •Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment
- •Immunization with inactivated vaccines (e.g. influenza) within 2 week prior to enrolment
- •Has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period
- •Subject in another clinical trial with an investigational drug or a biologic within 30 days of enrollment
- •Has received granulocyte-macrophage colony stimulating factor (G/GM-CSF) or erythropoietin (EPO) within 30 days of enrollment or likely to require GM-CSF or erythropoietin during the study period
- •Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease.
- •Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
- •History of allergic reactions or anaphylactic reaction to any vaccine component
- •Unwilling, or unable in the opinion of the investigator, to comply with study requirements
- •Immediate family members of study center staff
- •Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers
- •Known hepatitis C infection or positive Hepatitis C serology at screening, unless treated and cured
- •Known human immunodeficiency virus (HIV) infection or positive HIV serology at screening
- •Renal impairment with Glomerular Filtration Rate (GFR) <90 mL/min/ 1.73 m2 at screening
- •Uncontrolled hypertension
- •Diagnosis of Type 1 or Type 2 diabetes or HbA1C ≥ 6.5% at screening
- •Any laboratory test abnormality that would be considered of Grade 1 severity or above as per FDA guidelines for grading clinical laboratory abnormalities and is considered as clinically significant by the investigator.
研究组 & 干预措施
Sci-B-Vac Lot A Hep B Vaccination
Sci-B-Vac Lot A Hepatitis B Vaccination
干预措施: Hepatitis B Vaccination (Biological)
Sci-B-Vac Lot B Hep B Vaccination
Sci-B-Vac Lot B Hepatitis B Vaccination
干预措施: Hepatitis B Vaccination (Biological)
Sci-B-Vac Lot C Hep B Vaccination
Sci-B-Vac Lot C Hepatitis B Vaccination
干预措施: Hepatitis B Vaccination (Biological)
Comparator: ENGERIX-B Hep B Vaccination
Active Comparator: ENGERIX-B Hepatitis B Vaccination
干预措施: Hepatitis B Vaccination (Biological)
结局指标
主要结局
Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1)
时间窗: 4 weeks after third vaccination (Study Day 196)
To demonstrate the manufacturing equivalence, in terms of immunogenicity, as measured by GMC of antibodies, of 3 independent consecutive lots of the Sci-B-Vac® 4 weeks after the third vaccination. Lot-to-lot manufacturing consistency of Sci-B-Vac® is demonstrated if the 95% CIs of the adjusted anti-HBs GMC ratios between lots are within the pre-specified range of \[0.67, 1.5\].
次要结局
- Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)(Day of vaccine administration and six subsequent days)
- Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2)(4 weeks after third vaccination (Study Day 196))