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
- 43
- 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
- •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
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