NCT00291980已完成3 期
A Phase III, Multicentric, Multinational, Controlled, Randomised, Open Study Comparing the Immunogenicity, Reactogenicity and Safety of Henogen's New Adjuvanted Hepatitis B Vaccine, HB-AS02V, to That of Aventis Pasteur MSD's Hepatitis B Vaccine, HBVAXPRO® , Administered as a Booster Dose in Pre-Dialysis, Peritoneal Dialysis and Haemodialysis Subjects (³ 15 Years of Age) Who Previously Responded to Hepatitis B Primary Vaccination But Have Lost Antibody.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Henogen
- 入组人数
- 185
- 试验地点
- 55
- 主要终点
- Anti-HBs antibody geometric mean concentrations.
研究概览
简要总结
The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As the persistence of anti-HBs is closely related to the initial anti-HBs peak, a more immunogenic vaccine, allowing higher antibody concentrations, would be a benefit for this population.
详细描述
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 3 visits and blood samples will taken at each of these visits.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects whom the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •A male or female subject 15 years of age or older at the time of the study entry.
- •Written informed consent obtained from the subject/ subject's parents or guardians.
- •Pre-dialysis patients, peritoneal dialysis patients and patients on haemodialysis. Pre-dialysis patients is defined as a subject with a documented creatinine clearance of les or equal to 30 ml/min.
- •Seronegative for anti-HBc antibodies and for HBsAg at screening.
- •Documented previous hepatitis B vaccination with one full primary course of licensed vaccine (the cumulative dose for primary vaccination is at least 160 mg of hepatitis B vaccine) with or without subsequent boosters. The last dose should have been administered at least three months before the planned dose of study vaccine in this study.
- •Documented response to previous hepatitis B vaccination (i.e. anti-HBs antibody concentrations ³ 10 mIU/ml after primary vaccination or after booster/s with licensed vaccine), but for whom there is a loss of anti-HBs antibody concentrations below 10 mIU/ml at the time of inclusion into the study. Patients who have antibody concentrations below 50 mIU/ml at the time of inclusion will also be recruited provided that this antibody concentration is less than half of the highest documented antibody response achieved after primary vaccination or booster/s. The interval between the blood sample corresponding to the documented response and the hepatitis B vaccine dose received prior to this blood sample should be at least 25 days
- •If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used medically-approved contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
排除标准
- •Subjects who have participated in the HN014/HBV-001 or HN017/HBV-003 study
- •Use of any investigational or non-registered drug or vaccine within 30 days preceding the study vaccine administration, or planned use during the study period.
- •Use of any registered vaccine within 7 days preceding the study vaccine administration.
- •History of hepatitis B infection.
- •Known exposure to hepatitis B virus within six months.
- •Use of immunoglobulins within six months preceding the first study vaccination.
- •Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
- •Any confirmed or suspected human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral/ axillary temperature < 37.5°C (or 37 °C in Czech Republic).
- •Oral/axillary temperature equal or superior to 37.5 °C (or 37 °C in Czech Republic).
- •Pregnant or lactating female
结局指标
主要结局
Anti-HBs antibody geometric mean concentrations.
时间窗: Month 0 and Month 1
次要结局
- Seroprotection rates for all subjects(Months 0, 1)
- Seropositivity rates for all subjects(Month 0 and at Month 1)
- Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects(Month 0 and at Month 1)
- Geometric Mean Concentration of anti-HBs antibodies for all subjects and for seropositive subjects(Month 0 and Month 1)
- Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms during the 4-day follow-up after vaccination(Month 0)
- Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after vaccination(Month 0)
- Occurrence, intensity and relationship to vaccination of all serious adverse events up to Month 1(Month 0 to 1)
研究者
研究点 (55)
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