A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
研究概览
简要总结
A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety & efficacy
详细描述
A Multi-Center Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety & efficacy 12 subjects with pediatric MS
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)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages Eligible for Study: 5 Years to 17 Years
- •Genders Eligible for Study: Both
- •Accepts Healthy Volunteers: No Criteria
- •Subject is between 5 and 17 years of age, inclusive
- •Clinically diagnosed Pediatric MS
- •Definite Pediatric MS by the revised McDonald criteria (2005) (Appendix A), with a pediatric MS course
- •Expanded Disability Status Scale (EDSS) <= score 6.5 (Appendix B) Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 12 months prior to screening
- •Laboratory values within the following limits:
- •Creatinine 1 . 5 x high normal
- •Hemoglobin
排除标准
- •Subjects currently prescribed Campath or Lemtrada
研究组 & 干预措施
IFA Incomplete Freund's Adjuvant
IFA Incomplete Freund's Adjuvant is a vaccine adjuvant composed of a light mineral oil a surfactant system designed to make a water-in-oil emulsion
干预措施: IFA Incomplete Freund's Adjuvant (Biological)
NeuroVax
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant
干预措施: NeuroVax (Biological)
结局指标
主要结局
The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
时间窗: 26 Weeks
The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI \& to compare the increases of WBC white blood cell counts in subjects in the treatment groups with Pediatric MS
次要结局
- A Secondary clinical endpoint is the measurement of FOXP3+ expression(26 Weeks)
- A Secondary clinical endpoint is the measurment of EDSS scores(26 Weeks)
- A Secondary clinical endpoint is the measurement of clinical relapses(26 Weeks)