A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety & efficacy

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

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subjects currently prescribed Campath or Lemtrada