A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,374
- 试验地点
- 40
- 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
The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A subject must meet all of the following criteria to be eligible for the trial:
- •Inclusion Criteria:
- •Be 18-70 years of age, inclusive
- •Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
- •If a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening Visit through Week
- •Able and willing to provide informed consent
- •A subject with any one of the following criteria is not eligible for the trial:
排除标准
- •Previous receipt of any hepatitis B vaccine
- •History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV
- •History of autoimmune disorder
- •History of sensitivity to any component of study vaccines
- •Has received the following prior to the first injection:
- •Within 28 days:
- •Any vaccine
- •Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
- •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
- •At any time: An injection of DNA plasmids or oligonucleotide
- •If female: Pregnant, nursing, or planning to become pregnant during the trial
- •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
- •Any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments
研究组 & 干预措施
Engerix-B
1.0 mL Engerix-B (20 mcg HBsAg adsorbed on 500 mcg of aluminum hydroxide) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and 24, followed by a 32-week safety follow-up from the last dose of Engerix-B.
干预措施: Engerix-B (Biological)
HEPLISAV
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and placebo (saline injection) at Week 24, followed by a 52-week safety follow-up from the last active dose of HEPLISAV.
干预措施: HEPLISAV (Biological)
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 56
The percentage 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. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.
Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response
时间窗: Week 28
Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B
次要结局
未报告次要终点