An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
研究概览
简要总结
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
详细描述
Eligible participants will receive single doses of HEPLISAV-B® at Weeks 0, 4, 8, and 16 and will be followed through Week 68 or end of study (EOS). The study is designed to evaluate the immunogenicity over a 20-week period and safety over a 68-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects at least 18 years of age
- •Laboratory confirmed negative serology result to hepatitis B virus (HBV) surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc) prior to first study injection
- •Must be clinically stable and in the opinion of the investigator able to comply with all study procedures
- •Must be able and willing to provide informed consent
- •Receiving hemodialysis or will initiate hemodialysis within 4 weeks of first study injection
- •Women of childbearing potential (WOCBP) must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening visit through 4 weeks after the last dose of study injection. Acceptable birth control methods include but are not limited to oral contraceptive medication, an intrauterine device (IUD), an injectable contraceptive (such as medroxyprogesterone acetate or Depo-Provera®), a birth control patch, or a barrier method (such as condom or diaphragm with spermicide).
排除标准
- •Previous receipt of any hepatitis B vaccine
- •History of human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection or antibody to HIV or HCV
- •History of sensitivity to any component of study vaccine
- •Substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results
- •Recent or ongoing history of febrile illness (within 7 days of the first study injection)
- •Has received any of the following prior to the first study injection:
- •Within 14 days:
- •a. Any inactivated vaccine
- •Within 28 days:
- •Systemic corticosteroids (more than 3 consecutive days) or other immunomodulatory or immune suppressive medication with the exception of inhaled steroids
- •Any live virus vaccine
- •Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
- •Any other investigational medicinal agent
- •Within 90 days:
- •Blood products or immunoglobulin
- •If female and pregnant, nursing, or planning to become pregnant during the study
- •Undergoing chemotherapy or expected to receive chemotherapy during the study period
- •Has a medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments, including the following laboratory abnormalities which the investigator may consider if severe:
- •Thrombocytopenia
- •Leukocytosis
- •Neutropenia
- •Metabolic acidosis
- •Increased alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- •Hyperkalemia
- •Hypokalemia
- •Is scheduled to undergo a kidney transplant within 6 months of the first study injection
研究组 & 干预措施
HEPLISAV-B®
A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4).
干预措施: HEPLISAV-B® (Drug)
结局指标
主要结局
Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
时间窗: Week 0 (Visit 1) until Week 68 or early termination
Proportion of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations.
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
时间窗: Week 20
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
次要结局
- Serum Anti-HBsAg Geometric Mean Concentration (GMC)(Weeks 4, 8, 16, 20)
- Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response(Weeks 4, 8, 16, 20)
- Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mL(Weeks 4, 8, 16, 20)