NCT03264157已完成2 期
A Prospective, Randomized, Double-Blind Parallel-group, Non-inferiority Phase II/III Study of the Safety and Effectiveness of BPL HRIG With Co Administration of Active Rabies Vaccine in Healthy Subjects
Bio Products Laboratory2 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2017年12月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL
研究概览
简要总结
A prospective, randomized, blinded, parallel-group, non-inferiority, phase II/III study of the safety and effectiveness of simulated post-exposure prophylaxis with BPL HRIG with co-administration of active rabies vaccine in healthy subjects.
详细描述
Each subject will undergo a total of 9 visits. Subjects' eligibility will be assessed at Screening, which can occur up to 28 days prior to dosing. Following a repeat eligibility check at Day 0, eligible subjects will be randomized and dosed with the randomized treatment (BPL HRIG + vaccine or Comparator HRIG + vaccine) on Day 0. Further assessments will be conducted on Days 3, 5, 7, 14, 28, 49 and the end of study assessment on Day 140. Vaccine will be administered on Day 0, 3, 7, 14 and 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind study
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to sign an informed consent form.
- •Healthy male or female subjects aged 18 - 75 years inclusive.
- •No previous exposure to rabies virus, rabies vaccine and/or rabies immunoglobulin.
- •No significant abnormalities in hematology, biochemistry, or urinalysis according to the Principal Investigator's judgment.
- •No significant abnormalities in ECG according to the Investigator's judgment.
- •Females of child-bearing potential (defined from the onset of menstruation to one-year post- menopause and not surgically sterilized) who are (or become) sexually active must agree to practice contraception by using a highly effective (>98%) method for the duration of the study.
- •Females of child-bearing potential (defined from the onset of menstruation to one-year post- menopause and not surgically sterilized) must have a negative result on a serum at screening visit and a urine HCG-based pregnancy test at Day
- •Exclusion Criteria
- •Female subjects who are pregnant and/or lactating.
- •History of live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the last 3 months.
- •Planned live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the 3 months after Day
- •History of anaphylactic or anaphylactoid hypersensitivity reactions to chicken egg; history of mild allergic reactions to chicken egg, e.g., skin rash only, is not an exclusion criterion
- •History of hypersensitivity reaction to any of the following components of active rabies vaccine (US-FDA approved) e.g.: neomycin, bovine gelatin, trace amounts of chicken protein, chlortetracycline, and amphotericin B and in accordance with the product insert of the vaccine.
- •History of life-threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products.
- •History of life-threatening allergy to blood or blood products.
- •Fever at the time of the start of the injection (oral temperature >38ºC.) or acute illness at the time of the start of the injection. Subjects with fever on Day 0 may have entry to the study re-scheduled.
- •History of or ongoing bleeding disorder.
- •Previous organ transplant recipient.
- •Ongoing immunosuppressive illness.
- •Clinically significant illnesses including: cardiac, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal or other) that in the opinion of the investigator, could interfere with the safety, compliance or other aspects of this study.
- •All types of malignancies except for basal and squamous cell (scaly or plate-like) skin cancer, in- situ cervical carcinoma must be in remission for a minimum of 5 years prior to Day
- •For non-melanoma skin cancers and carcinoma in-situ of the cervix may be enrolled if treated and cured at the time of screening.
- •Evidence of active systemic infection that requires treatment with antibiotics within 2 weeks prior to Day
- •Currently receiving or have received within the past 6 months (prior to Day 0):
- •immunosuppressive drugs
- •immunomodulatory drugs
- •Currently receiving or have received oral or IV steroids within 14 days (prior to DAY 0) or expected to require oral or IV steroids during the study.
- •Evidence of uncontrolled hypertension (systolic blood pressure of >150 mmHg, and/or diastolic blood pressure of >100 mmHg).
- •Heart rate >120/min.
- •Weight > 95.5 kg
- •History of IgA deficiency.
- •Is positive for any of the following at screening: serological test for HIV 1&2, HCV or HBsAg.
- •Presence of psychiatric disorder, other mental disorder or any other medical disorder which might impair the subject's ability to give informed consent or to comply with the requirements of the study protocol.
- •Previous enrollment in this study.
- •Participation in an interventional clinical trial within 30 days prior to baseline visit (Day 0).
- •Evidence of alcohol abuse or history of alcohol abuse or illegal and/or legally prescribed drugs in the past 2 years.
- •Any other factor that, in the opinion of the investigator, would prevent the subject from complying with the requirements of the protocol.
排除标准
- 未提供
研究组 & 干预措施
BPL HRIG + RabAvert
Experimental
20 IU/kg dose HRIG + active rabies vaccine
干预措施: HRIG (Drug)
BPL HRIG + RabAvert
Experimental
20 IU/kg dose HRIG + active rabies vaccine
干预措施: RabAvert (Biological)
Comparator HyperRab + RabAvert
Active Comparator
20 IU/kg dose HRIG + active rabies vaccine
干预措施: HyperRAB (Drug)
Comparator HyperRab + RabAvert
Active Comparator
20 IU/kg dose HRIG + active rabies vaccine
干预措施: RabAvert (Biological)
结局指标
主要结局
Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL
时间窗: Day 14
Non-inferiority in terms of the proportion of subjects with anti-rabies antibody titer of ≥0.5 IU/mL after study drug administration using a non-inferiority margin of 10%.
次要结局
- Analysis of AUC0-7d(Day 0 to Day 7)
- RVNA Geometric Mean Titers at Days 3, 5, 7 and 14(Days 3, 5, 7 and 14)
- Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ 0.5 IU/mL by Visit(Days 3, 5, 7, 14, 28, 49, and 140)
- Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ LLOQ of the Assay by Visit(Days 3, 5, 7, 14, 28, 49, and 140)
- RVNA Geometric Mean Titers at Days 14, 28, 49 and 140(Days 14, 28, 49 and 140)
研究者
研究点 (2)
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