NL-OMON41999已完成不适用
Safety and immunogenicity of HBAI20 adjuvanted Hepatitis B vaccine in naive adults and non-responders - HBAI20
适应症
试验速览
- 阶段
- 不适用
- 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
- •Naive subjects must meet all of the following criteria:
- •- 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 enrolment
- •- Willing and able to adhere to the study regimen
- •- Having a signed informed consent form
- •Non-responders:
- •- Documented non-responders: Subjects with documented two cycles of Hepatitis B vaccination (total of 6 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
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •- Any infectious disease at the time of screening and/or enrolment
- •- 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)
- •- Any vaccination within 3 months before screening
- •- Blood donation within 1 month before screening and during the trial (until last visit)
- •- Administration of plasma (incl. immunoglobulins) or blood products within 3 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 7
- •- Females: positive urine pregnancy test. Urine test negative at screening date and negative urine pregnancy test on the day of vaccination
- •- 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
- •Exclusion criterion for Hepatitis B naïve subjects (groups 1 and 2):
- •- Previous vaccination with Hepatitis B vaccine
- •Exclusion criterion for non-responders (group 3):
- •- Any Hepatitis B vaccination in the last 6 months
- •Temporary exclusion criteria for vaccination
- •- Ear temperature > 38.4°C will lead to postponement of participation and vaccination. Screening may continue when the temperature has normalized.
研究者
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