Proof Of Concept Study: Immunogenicity and Safety of Hepatitis B Injection in the Dermis in Healthy Volunteers Using an Intradermal Injection Device (VAX-ID)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novosanis NV
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects
研究概览
简要总结
A proof of concept (POC) study will be conducted in 44 volunteers that have been fully vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a newly developed intradermal injection device VAX-ID, compared to intramuscular and intradermal (Mantoux technique) injection.
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
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults, checked anamnestically (based on medical history) at entry of the study
- •18-35 years
- •vaccination status: fully vaccinated against hepatitis B at least 5 years ago, with proof of vaccine response (to avoid non-response among the subjects). Subjects has to ask for a document of this proof at the service occupational medicine of the University of Antwerp.
- •capable of understanding, reading and writing Dutch
排除标准
- •other vaccination(s) 4 weeks before study onset
- •pregnancy and lactation (women will be questioned during anamnesis)
- •plan to have other vaccination during the study period
研究组 & 干预措施
Intramuscular group
These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region.
干预措施: 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) (Drug)
Intradermal group (Mantoux)
These subjects will receive one intradermal injection with mantoux technique in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur-MSD) will be injected.
干预措施: 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) (Drug)
Intradermal group (VAX-ID) A
These subjects will receive one intradermal injection with the newly developed intradermal injection device VAX-ID in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected.
干预措施: VAX-ID (Device)
Intradermal group (VAX-ID) B
These subjects will receive two intradermal injections with two newly developed intradermal injection devices VAX-ID in both forearms each 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected.
干预措施: VAX-ID (Device)
结局指标
主要结局
Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects
时间窗: after 14 days
次要结局
- Safety: solicited local and systemic reactions, unsolicited adverse events and Serious Adverse Events occurrence, intensity and relationship to vaccination of all Adverse Events reported during the 14-day follow-up period after the challenge dose(during 14 days post vaccination)