NCT02559921已完成2 期
Safety and Immunogenicity Study of Recombinant Human Rabies Immunoglobin (rhRIG) in Combination With Rabies Vaccine for Human Use With Human Rabies Immune Globulin (HRIG) in Combination With Rabies Vaccine for Human Use in Healthy Adult Subjects.
Beijing Chaoyang District Centre for Disease Control and Prevention0 个研究点目标入组 300 人开始时间: 2014年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- Evaluate the detection rate of the rabies virus neutralizing antibody (RVNA) activities of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects
研究概览
简要总结
This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG（20 IU/kg）only, rhRIG（40 IU/kg）only,HRIG（20 IU/kg）only, rhRIG（20 IU/kg）in combination with rabies vaccine for human use, rhRIG（40 IU/kg）in combination with rabies vaccine for human use,HRIG（20 IU/kg）in combination with rabies vaccine for human use,and placebo in combination with rabies vaccine for human use,respectively.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged at least 18 years but not more than 55 years;
- •According to medical history, physical examination and clinical judgment of investigator at enrollment, subjects should have no significant health problems, or their health status or medication treatment remain stable;
- •Subjects and their spouses should use adequate contraceptive methods from the screening day to Day 90;
- •Male subjects must agree not to donate sperm from the first day of enrollment to Day 90;
- •Subjects should sign a written Informed Consent Form;
排除标准
- •Previous exposure or immunization histories of rabies (rabies vaccine and/or immunoglobulin);
- •According to the clinical judgment of investigator, subjects had clinically significant acute disease or infection, including pyrexia (>37.0℃) within 2 weeks before the initial dose;
- •After review of medical history or physical examination results, it is found that subjects have medical histories of abnormalities of heart, liver, kidney, blood, digestive tract, nervous system, spirit and metabolism;
- •Subjects are pregnant or plan to become pregnant or are breast-feeding during the study;
- •According to the judgment of investigator, subjects have clinically significant immunodeficiency or medical history and/or family history of autoimmune disease;
- •According to the judgment of investigator, subjects have known or suspected clinically significant anaphylaxis or hypersensitivity reactions;
- •Immunization has been arranged for the subjects within the next 3 months after the initial dose;
- •Subjects have used immunosuppressive preparations or other immunomodulating agents for more than 14 days within 6 months before the initial dose of study drug;
- •Subjects used hormone agents within 3 days before the initial dose;
- •Subjects donated blood or lost a lot of blood within 56 days before the initial dose;
- •Subjects donated plasma within 7 days before the initial dose;
- •Subjects received transfusion of blood or blood products within 6 months before the initial dose;
- •It is suspected that subjects do not follow study procedures;
- •Intake of alcohol within 12 hours before the initial dose;
- •Subjects smoke more than 20 cigarettes a day;
- •Subjects are obviously allergic to antibiotics;
- •Any other conditions which may affect trial assessment at the discretion of the investigator;
结局指标
主要结局
Evaluate the detection rate of the rabies virus neutralizing antibody (RVNA) activities of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects
时间窗: 42 days
次要结局
- Evaluate the rate of adverse reactions of rhRIG or HRIG in combination with rabies vaccine for human use (Vero cells) in healthy subjects(42 days)
研究者
相似试验
已完成
1 期
Rabies G Protein Vaccine study for immunization against RabiesCTRI/2014/04/004538Cadila Pharmaceuticals Limited170
已完成
3 期
Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies VaccineRabies VirusRabiesNCT01339312Sanofi Pasteur, a Sanofi Company816
已完成
2 期
Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure RegimenRabiesNCT01877395Sanofi Pasteur, a Sanofi Company342
已完成
3 期
Immunogenicity and safety study of Rabies G protein Vaccine administered as a simulated post-exposure immunization in healthy volunteersCTRI/2016/08/007137Cadila Pharmaceuticals Limited800
已完成
2 期
Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure UseRabiesNCT01784874Sanofi Pasteur, a Sanofi Company408