EUCTR2016-002720-91-NL进行中（未招募）1 期
Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non-responders. - Phase 2 HBAI20 Hepatitis B vaccine in non-responders
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CyTuVax BV
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the clinical investigator
- •Age 18 to 59 years, inclusive at the time of enrollment
- •Willing and able to adhere to the study regimen
- •Having a signed informed consent form
- •Documented non-responders: Subjects with documented one or more cycles of Hepatitis B vaccination (total of 3 or more vaccinations) and titer analysis that show that they have not developed the Hepatitis B antibody titer recommended after standard vaccination: anti-HBsAg antibody titer superior to 10mIU/ml
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any infectious disease at the time of screening and/or enrollment
- •Positive HIV, Hepatitis B virus or Hepatitis C virus serology
- •Known or suspected immune deficiency
- •Known or suspected disease that influences the immune system including chronic allergies that require frequent anti-allergy medication, cancer and transplantation recipients
- •Known or suspected allergy to any of the vaccine components: see IB, IMPD
- •Dialysis patient
- •History of unusual or severe reactions to any previous vaccination
- •History of any neurologic disorder, including epilepsy and autism
- •Use of medication that influences the immune system (immune suppressive treatment or daily use of corticosteroids)
- •Any vaccination within 3 months before screening
- •Blood donation within 1 month before screening
- •Administration of plasma (incl. immunoglobulins) or blood products within 12 months before screening
- •Participation in another clinical trial within 3 months before screening
- •Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
- •Bleeding disorders, or use of medication for bleeding disorders, and use of anti-coagulants
- •Female subjects planning to become pregnant or breastfeeding babies until visit 4
- •Females: positive urine pregnancy test at screening date
- •Excessive alcohol or controlled drug use - More than 2 alcohol measures per day (one alcohol measure is a beer (250ml) or one glass of wine (125ml) or one strong measure (35ml) or one port/sherry (75ml)). Regular use of controlled drugs
- •Any Hepatitis B vaccination in the last 6 months
研究者
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