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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02200718
• Other study ID #: IR902-007
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 31, 2020
• Est. completion date: November 9, 2024

Study information

• Verified date: March 2020
• Source: Immune Response BioPharma, Inc.
• Contact: Richard M Bartholomew, Ph.D
• Phone: 1-858-414-4664
• Email: Richardmbartholomew[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: November 9, 2024
• Est. primary completion date: November 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	CRO	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Immune Response BioPharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A Secondary clinical endpoint is the measurement of FOXP3+ expression	Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups	26 Weeks
Secondary	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.	26 Weeks
Secondary	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	26 Weeks

External Links

•   Immune Response BioPharma, Inc.