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

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NeuroVax
IFA Incomplete Freund's Adjuvant
Sponsored by
Immune Response BioPharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • CRO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NeuroVax

IFA Incomplete Freund's Adjuvant

Arm Description

NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

A Secondary clinical endpoint is the measurement of FOXP3+ expression
Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups
A Secondary clinical endpoint is the measurment of EDSS scores
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.
A Secondary clinical endpoint is the measurement of clinical relapses
To compare the Analysis of clinical relapses between the treatment groups of Pediatric MS subjects at week 26

Full Information

First Posted
July 17, 2014
Last Updated
March 30, 2020
Sponsor
Immune Response BioPharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02200718
Brief Title
A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Official Title
A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 31, 2020 (Anticipated)
Primary Completion Date
November 9, 2024 (Anticipated)
Study Completion Date
November 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immune Response BioPharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NeuroVax
Arm Type
Experimental
Arm Description
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant
Arm Title
IFA Incomplete Freund's Adjuvant
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Biological
Intervention Name(s)
NeuroVax
Other Intervention Name(s)
IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
Intervention Description
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
Intervention Type
Biological
Intervention Name(s)
IFA Incomplete Freund's Adjuvant
Intervention Description
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
Primary Outcome Measure Information:
Title
The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
Description
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
Time Frame
26 Weeks
Secondary Outcome Measure Information:
Title
A Secondary clinical endpoint is the measurement of FOXP3+ expression
Description
Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups
Time Frame
26 Weeks
Title
A Secondary clinical endpoint is the measurment of EDSS scores
Description
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.
Time Frame
26 Weeks
Title
A Secondary clinical endpoint is the measurement of clinical relapses
Description
To compare the Analysis of clinical relapses between the treatment groups of Pediatric MS subjects at week 26
Time Frame
26 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard M Bartholomew, Ph.D
Phone
1-858-414-4664
Email
Richardmbartholomew@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M Bartholomew, Ph.D
Organizational Affiliation
Immune Response BioPharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
CRO
City
San Diego
State/Province
California
ZIP/Postal Code
92129
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard M Bartholomew, PhD
Phone
858-414-4664
Email
Richardmbartholomew@gmail.com

12. IPD Sharing Statement

Links:
URL
http://www.immuneresponse.net
Description
Immune Response BioPharma, Inc.

Learn more about this trial

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

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