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

NCT02200718 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: IR902-007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic

Outcome Measures

Primary Outcomes (1)

• The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups

  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

  26 Weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

NeuroVax

EXPERIMENTAL

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

Biological: NeuroVax

IFA Incomplete Freund's Adjuvant

PLACEBO COMPARATOR

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

Biological: IFA Incomplete Freund's Adjuvant

Interventions

NeuroVax BIOLOGICAL

NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1

Also known as: IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1

NeuroVax

IFA Incomplete Freund's Adjuvant BIOLOGICAL

IFA Incomplete Freund's Adjuvant is a vaccine adjuvant composed of a light mineral oil and a surfactant system designed to make a water-in-oil emulsion

IFA Incomplete Freund's Adjuvant

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Subjects currently prescribed Campath or Lemtrada

Sponsors & Collaborators

• Immune Response BioPharma, Inc.: lead

Study Sites (1)

CRO

San Diego, California, 92129, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

NeuroVax vaccine; HIV-1 immunogen, incomplete Freund's adjuvant

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Richard M Bartholomew, Ph.D

  Immune Response BioPharma, Inc.

  STUDY DIRECTOR

Central Study Contacts

Richard M Bartholomew, Ph.D

CONTACT

1-858-414-4664; Richardmbartholomew@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 25, 2014
• Study Start: December 31, 2020
• Primary Completion: November 9, 2024
• Study Completion: November 9, 2024
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

US (1)