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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2022-03-09

Brief Summary

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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.

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Detailed Description

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

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NeuroVax

Group Type EXPERIMENTAL

NeuroVax

Intervention Type BIOLOGICAL

NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA

IFA Incomplete Freund's Adjuvant

Incomplete Freund's Adjuvant IFA

Group Type PLACEBO_COMPARATOR

IFA Incomplete Freund's Adjuvant

Intervention Type BIOLOGICAL

IFA Placebo Incomplete Freund's Adjuvant

Interventions

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NeuroVax

NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA

Intervention Type BIOLOGICAL

IFA Incomplete Freund's Adjuvant

IFA Placebo Incomplete Freund's Adjuvant

Intervention Type BIOLOGICAL

Eligibility Criteria

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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