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

A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02149706

Enrollment

150

Registered

2014-05-29

Start date

2020-03-09

Completion date

2022-03-09

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Secondary Progress Multiple Sclerosis, SPMS, Multiple Sclerosis, NeuroVax

Brief summary

Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 150 subjects with Secondary Progressive SPMS.

Detailed description

The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.

Interventions

BIOLOGICALNeuroVax

NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA

BIOLOGICALIFA Incomplete Freund's Adjuvant

IFA Placebo Incomplete Freund's Adjuvant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Ages Eligible for Study: 18 Years to 70 Years * Genders Eligible for Study: Both * Accepts Healthy Volunteers: No Criteria * Subject is between 18 and 70 years of age, inclusive. * Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course. * Expanded Disability Status Scale (EDSS) \>=score 3.5 (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 1 2 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

Design outcomes

Primary

Measure	Time frame	Description
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score	48 Weeks	The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements

Secondary

Measure	Time frame	Description
Secondary measurements objectives immunologic evaluations	48 Weeks	Secondary measurements objectives immunologic evaluations increases in white blood cell counts & FOXP+3 expression increases

Countries

United States

Contacts

Primary ContactRichard M Bartholomew, Ph.D

Richardmbartholomew@gmail.com1-858-414-4664

Backup ContactRichard Bartholomew

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026