NCT00985426已完成3 期
An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV-B® to Licensed Vaccine (Engerix-B®) Among Adults(18 to 75 Years of Age) With Chronic Kidney Disease (CKD)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 521
- 试验地点
- 2
- 主要终点
- Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
研究概览
简要总结
The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 18 to 75 years of age;
- •progressive loss of renal function as defined by glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m²;
- •be clinically stable in the opinion of the investigator;
- •be serum negative for HBsAg, anti-HBsAg, antibody to hepatitis B core antigen (HBcAg), Hepatitis C virus (HCV), and human immunodeficiency virus (HIV);
- •if a woman of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase and for up to 28 days after the last injection;
- •is not scheduled to undergo a kidney transplant in the next 12 months;
- •be able and willing to provide informed consent.
排除标准
- •if female, is pregnant, breastfeeding, or planning a pregnancy;
- •has a history of or is considered by the investigator to be at high risk for recent exposure to HBV, HCV, or HIV; for example, current intravenous drug use, has unprotected sex with known HBV/HIV positive partner;
- •has known history of autoimmune disease;
- •has previously received any HBV vaccine;
- •has a history of sensitivity to any component of study vaccines;
- •has current illness other than renal disease or has substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results;
- •is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin;
- •has uncontrolled diabetes or hypertension;
- •is unwilling or unable to comply with all the requirements of the protocol;
- •has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period;
- •has received the following prior to the first injection:
- •3 days: erythropoietin (exclusionary window does not apply for subjects on dialysis)
- •7 days: intravenous iron
- •21 days: any inactivated virus vaccine
- •any live virus vaccine
- •systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids
- •granulocyte or granulocyte-macrophage colony-simulating factor (G/GM-CSF), any other investigational medicinal agent
- •At any time: an injection of deoxyribonucleic acid plasmids or oligonucleotide
结局指标
主要结局
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
时间窗: Week 28
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B compared to that after Engerix-B.
次要结局
- Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52(Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52)
- SPR of Participants With Type 2 Diabetes Mellitus at Week 28(Week 28)
- Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit(7 days after each injection visit (Weeks 0, 4, 8, and 24))
- Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52(Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52)
- Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52(Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52)
研究者
研究点 (2)
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