A Phase 3 Double-Blind Randomized Controlled Trial 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 (PROTECT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,607
- 试验地点
- 38
- 主要终点
- Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 45 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196
研究概览
简要总结
This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in ≥ 45 years old.
详细描述
This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 45 years old. Study subjects are randomized 1:1 to receive either a total of 3 injections of Sci-B-Vac® or 3 injections of Engerix-B® intra-muscularly (IM) on Days 0, 28, and 168.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any gender.
- •Age ≥ 18 years
- •In stable health as determined by a physical examination and laboratory tests values. Common chronic conditions such as, but not limited to, type 2 diabetes, high blood pressure, Chronic Obstructive Pulmonary Disease (COPD) and asthma will be accepted if the condition is well controlled, as determined by the investigator, and not meeting the exclusion criteria. For subjects > 65 years old, Frailty Index ≤3
- •If female, either is not of childbearing potential or is of childbearing potential and must agree to use an adequate birth control method during the screening period and until the end of her participation in the study
- •Able and willing to give consent.
排除标准
- •Previous vaccination with any Hep B vaccine (licensed or experimental).
- •Treatment by immunosuppressant within 30 days of enrollment including but not limited to corticosteroids at a dose that is higher than an oral or injected physiological dose, or a prednisolone-equivalent dose > 20 mg /day (Inhaled and topical steroids are allowed).
- •Known 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 weeks 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 (Engerix-B® or Sci-B-Vac®)
- •Unwilling, or unable in the opinion of the investigator, to comply with study requirements, including the use of an adequate birth control method
- •Immediate family members of study center staff (parents, sibling, children)
- •Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers at screening
- •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 at screening
- •Uncontrolled diabetes mellitus
- •Uncontrolled hypertension
- •Any laboratory test abnormality that would be considered of Grade 1 severity and is considered as clinically significant by the investigator. Grade 3 severity or above is exclusionary, regardless of clinical assessment.
- •Diagnosis of advanced stage heart failure or Unstable Angina.
结局指标
主要结局
Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 45 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196
时间窗: Day 196
To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is superior to the SPR 4 weeks after completion of the three-dose regimen of Engerix-B® in older adults ≥ 45 years old i.e. the lower bound of the 95% two-sided CI of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after receiving the third vaccination, will be \> 5%.
Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 18 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196
时间窗: Day 196
To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is non-inferior to a three-dose regimen of Engerix-B® in adults ≥18 years old; i.e. the lower bound of the 95% two-sided confidence interval (CI) of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after the third vaccination, will be \> - 5%.
次要结局
- Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)(Day of vaccine administration and six subsequent days)