Intradermal Rabies Immunization Using NanoJect: A Comparative Study

University of Lausanne Hospitals0 个研究点目标入组 66 人开始时间: 2013年8月最近更新: 2020年3月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 66
主要终点: Pain following product injection as a Measure of Safety and Tolerability

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The study is planned as a single-center, randomized, double-blind placebo-controlled, comparative Phase I, first-in-man study to assess the safety and tolerability of the NanoJect™ device, and the immunogenicity of the rabies vaccine "Vaccin rabique Pasteur®" delivered with the NanoJect™ device by ID route.

详细描述

This study will enroll 66 volunteers randomly assigned to one of the three study arms. Each volunteer will receive three injections at each of three vaccination visits. Total study duration per volunteer is 2 months.

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 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Has completed the written informed consent process.
•Is male or female aged 18 years and 50 years.
•Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study.
•Agrees to avoid elective surgery for the duration of the study.
•For female subjects: agrees to avoid pregnancy through the duration of the study.
•Is in good general health, confirmed by medical history, physical examination and screening laboratory tests.

排除标准

•Oral body temperature 37.5 Celcius (C).
•History or evidence of rabies vaccination or rabies contact.
•Abnormal CBC (Complete Blood Count) laboratory values (>10% above Upper Limit of Normal (ULN) or >10% below Lower Limit of Normal (LLN)) and abnormal biochemistry values from blood collected at screening (>10% above ULN or >10% below LLN). Analysis can be repeated upon request of the clinician.
•History or evidence of autoimmune disease.
•History or evidence of any past, present, or future possible immunodeficiency state, including HIV 1 infection.
•History or evidence of chronic hepatitis, including presence of anti-hepatitis B core antibodies or anti-hepatitis C antibodies.Participation in any other investigational study during the study period.
•Received immunoglobulin or blood products within 90 days prior to study visit
•Received any investigational drug therapy or investigational vaccine within 180 days prior to study.
•Received any licensed vaccine within 45 days prior to study visit 2 (note: the use of licensed vaccines medically indicated during the study is permitted at any time).
•History or evidence of any treatment that, in the opinion of the investigator, may interfere with the vaccine response or compromise the safety of the subject.
•Received Chloroquin and/or Proguanil treatment within 420 days prior to study.
•Use of immunosuppressive drugs or anticoagulants.
•All female subjects: currently pregnant or lactating/nursing; positive screening urine pregnancy test; or positive urine pregnancy test on the day of any study vaccination
•History or evidence of allergic disease or reaction that, in the opinion of the investigator, may compromise the safety of the subject (Notably: allergy to active principle, excipients, polymyxin B, Streptomycin, Neomycin).
•History or evidence of dermatologic disease that, in the opinion of the investigator, may interfere with the assessment of injection site reactions.
•History or evidence of any other acute or chronic disease that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine or compromise the safety of the subject.
•Medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the subject will comply with the protocol.
•History or evidence of any brain disease that, in the opinion of the investigator, may interfere with the vaccine and compromise the safety of the subject.
•Abnormal urinalysis at the screening visit that, in the opinion of the investigator, is clinically significant.
•Skin coloration (skin color, tattoo, freckles) that, in the opinion of the investigator, could interfere with injection reactogenicity assessment.
•Body Mass Index (BMI)<= 18 and => 33 (weight/height2). Immediate need of rabies immunization.

研究组 & 干预措施

Vaccine injected ID with classical syringe

Placebo Comparator

Right forearm, ID with NanoJect device (DebioJect™) filled with placebo (0.1mL);

Left forearm, ID with classical syringe filled with vaccine (0.1mL);

Non-dominant deltoid, Intramuscular (IM) with classical syringe filled with placebo (0.5mL).

干预措施: NanoJect device (DebioJect™) (Device)

Vaccine injected ID with classical syringe

Placebo Comparator

Right forearm, ID with NanoJect device (DebioJect™) filled with placebo (0.1mL);

Left forearm, ID with classical syringe filled with vaccine (0.1mL);

Non-dominant deltoid, Intramuscular (IM) with classical syringe filled with placebo (0.5mL).

干预措施: Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus) (Device)

Vaccine injected ID with classical syringe

Placebo Comparator

Right forearm, ID with NanoJect device (DebioJect™) filled with placebo (0.1mL);

Left forearm, ID with classical syringe filled with vaccine (0.1mL);

Non-dominant deltoid, Intramuscular (IM) with classical syringe filled with placebo (0.5mL).

干预措施: Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus) (Device)

Vaccine injected ID with classical syringe

Placebo Comparator

Right forearm, ID with NanoJect device (DebioJect™) filled with placebo (0.1mL);

Left forearm, ID with classical syringe filled with vaccine (0.1mL);

Non-dominant deltoid, Intramuscular (IM) with classical syringe filled with placebo (0.5mL).

干预措施: Vaccin rabique Pasteur® (Drug)

Vaccine injected ID with classical syringe

Placebo Comparator

Right forearm, ID with NanoJect device (DebioJect™) filled with placebo (0.1mL);

Left forearm, ID with classical syringe filled with vaccine (0.1mL);

Non-dominant deltoid, Intramuscular (IM) with classical syringe filled with placebo (0.5mL).

干预措施: Placebo (Drug)