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

March 30, 2020 updated by: Immune Response BioPharma, Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeuroVax
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
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
Other Names:
  • IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
Placebo Comparator: 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
Biological: IFA Incomplete Freund's Adjuvant
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
Time Frame: 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
26 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Secondary clinical endpoint is the measurement of FOXP3+ expression
Time Frame: 26 Weeks
Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups
26 Weeks
A Secondary clinical endpoint is the measurment of EDSS scores
Time Frame: 26 Weeks
To compare between treatment groups the Measures of neurologic disability EDSS scores utilizing the Kurtzke scale, Patients will be assessed using the EDSS, a 25-foot timed walk, and a nine-hole peg test assessments at weeks 0, 4, 8, 12, 16, 20 & 26 visit then exit the study.
26 Weeks
A Secondary clinical endpoint is the measurement of clinical relapses
Time Frame: 26 Weeks
To compare the Analysis of clinical relapses between the treatment groups of Pediatric MS subjects at week 26
26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immune Response BioPharma, Inc.

Investigators

  • Study Director: Richard M Bartholomew, Ph.D, Immune Response BioPharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 31, 2020

Primary Completion (Anticipated)

November 9, 2024

Study Completion (Anticipated)

November 9, 2024

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR902-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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