NL-OMON47410已完成2 期
Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non-responders - Phase 2 HBAI20 Hepatitis B vaccine in non-responders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CyTuVax BV
- 入组人数
- 59
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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 two 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
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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