Immunogenicity and Safety of HBAI20 Hepatitis B Vaccine in Non-responders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 4
- 主要终点
- Immunogenicity of the HBAI20
研究概览
简要总结
In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection in registered non-responders (adults who were previously vaccinated with the HBVaxPro-10μg but did not achieve seroprotection). The study will further assess the safety of the HBAI20 vaccine in comparison with HBVaxPro-10μg.
详细描述
Rationale:
Worldwide, people are suffering from the consequences of Hepatitis B (HB) virus infection. Currently available vaccines are protective in most of the vaccinees, however, a small part of the population does not respond to these vaccines (non-responders). A new adjuvant (AI20) has been developed by CyTuVax to improve the standard Hepatitis B vaccine for the protection of non-responders. The AI20 adjuvant consists of depot-attached rhuIL-2 (aggregated Interleukin-2 (IL-2) molecules attached to alum), facilitating the slow release of highly concentrated IL-2 nano aggregates. In preclinical experiments, vaccination of mice, rats, and rabbits with the new HBAI20 vaccine results in higher and earlier immune responses to HBsAg compared to vaccination with one of the standard Hepatitis B vaccines. The phase 1 clinical trial showed that the HBAI20 vaccine was well tolerated and it induced protective anti Hepatitis B antibody titers in 9 out of 10 non-responders (subjects vaccinated at least 6 times with the Hepatitis B vaccine). The phase 2 clinical trial will be conducted in order to assess the immunogenicity and safety of the AI20 adjuvant and further test if the AI20 adjuvanted Hepatitis B vaccine induces protective antibody titers in the vaccinated non-responders.
Objective: In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection. Furthermore, the investigators will compare the safety of the HBAI20 vaccine with the HBVaxPro-10μg.
Study design:
Multicenter double blinded randomized controlled intervention phase II study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
- •Willing to adhere to a highly effective birth control method during the duration of the study
- •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 1 to 3 months after the last vaccination that show that they have not developed the Hepatitis B antibody titer recommended after standard vaccination: HBsAg antibody titer superior to 10mIU/ml. In case the subjects do not have a titer analysis performed 1 to 3 months after their last recorded vaccination, the potential subject can be included after permission from the project leader after analysis of the case file.
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 - excluding anti-histaminics -, cancer and transplantation recipients
- •Known or suspected allergy to any of the vaccine components
- •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, including chronic use of local corticosteroids)
- •Any vaccination within 3 months before screening excluding flu vaccination
- •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. Participants on coumadins anticoagulants and participants receiving 2 platelet aggregation inhibitors can not be included in the study. People on the direct oral anticoagulant dabigatran, apixaban, edoxaban, and rivaroxaban and participants using only one platelet aggregation inhibitor can be included.
- •Female subjects planning to become pregnant or breastfeeding babies until visit 4
- •Females: positive 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 3 months Temporary exclusion criterion for vaccination
- •Temperature > 38.4°C will lead to postponement of participation and vaccination.
- •Screening may continue when the temperature has normalized.
结局指标
主要结局
Immunogenicity of the HBAI20
时间窗: Six weeks after the third vaccination.
Anti Hepatitis B surface antigen antibody titer.
次要结局
- Safety of the HBAI20 Hepatitis B vaccine: Percentage of subjects reporting adverse events after being vaccinated.(The whole duration of the study protocol (102 days))