A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis

Immune Response BioPharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Multiple Sclerosis

Treatments: Biological: NeuroVax; Biological: IFA Incomplete Freund's Adjuvant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02200718

IR902-007

Details and patient eligibility

About

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

Full description

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

Enrollment: 12 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

NeuroVax

Experimental group

Description:

NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant

Treatment:

Biological: NeuroVax

IFA Incomplete Freund's Adjuvant

Placebo Comparator group

Description:

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

Treatment:

Biological: IFA Incomplete Freund's Adjuvant