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Trial record 16 of 1680 for:    "Multiple Sclerosis"

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

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ClinicalTrials.gov Identifier: NCT02200718
Recruitment Status : Not yet recruiting
First Posted : July 25, 2014
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Immune Response BioPharma, Inc.

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: NeuroVax Biological: IFA Incomplete Freund's Adjuvant Phase 1

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  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Study Start Date : November 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200718


Contacts
Contact: Richard M Bartholomew, Ph.D 1-858-414-4664 Richardmbartholomew@gmail.com

Locations
United States, Oregon
Multiple Sclerosis Center Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Richard M Bartholomew, PhD    858-414-4664    Richardmbartholomew@gmail.com   
Principal Investigator: Dennis Bourdette, MD F.A.A.N.         
Sponsors and Collaborators
Immune Response BioPharma, Inc.
Oregon Health and Science University
Investigators
Study Chair: Dennis Bourdette, FAAN MD Oregon Health and Science University
Study Director: Richard M Bartholomew, Ph.D Immune Response BioPharma, Inc.

Additional Information:
OHSU  This link exits the ClinicalTrials.gov site

Responsible Party: Immune Response BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT02200718     History of Changes
Other Study ID Numbers: IR902-007
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Immune Response BioPharma, Inc.:
Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic