A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 277
- 主要终点
- The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7
研究概览
简要总结
To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients
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
- 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 HbsAg (hepatitis b virus), anti-HBs (antibody to hepatitis B surface antigen), and anti HBc (antibody to hepatitis B core antigen) within 6 weeks of the initial dose of study vaccine
- •Patient on renal dialysis or a pre-dialysis patient with a creatinine clearance of <=30 ml/min
排除标准
- •Previous hepatitis B infection, vaccination with any hepatitis B vaccine
- •Recent febrile illness; hypersensitivity to any component of licensed hepatitis B vaccines
- •Recent administration of immune globulin, licensed inactivated vaccine within 14 days or licensed live vaccine within 30 days prior to receipt of first study vaccine
- •Receipt of investigational drugs or investigational vaccines within 3 months prior
- •Impairment of immunologic function
- •Recent use of systemic immunomodulatory medications
- •Pregnant women, nursing mothers or women planning to become pregnant
研究组 & 干预措施
Modified process hepatitis B vaccine
Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
干预措施: Comparator: modified process hepatitis B vaccine (Biological)
ENGERIX-B™2
ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
干预措施: Comparator: ENGERIX-B™ (Biological)
结局指标
主要结局
The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7
时间窗: 7 months (1 month after the third dose)
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose).
The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9
时间窗: 9 months (1 month after the fourth dose)
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 9 (1 month after the fourth dose).
The Total Number of Participants With One or More Injection-Site Adverse Experiences
时间窗: Days 1-15 After Any Vaccination
The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C
时间窗: Days 1-5 After Any Vaccination
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
时间窗: 0-9 months (recorded from first dose until the participant completes or discontinues the study)
Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose).
次要结局
未报告次要终点