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

NCT ID: NCT02200718

Last Updated: 2020-03-31

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

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2024-11-09

Brief Summary

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

Detailed Description

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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

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

NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant

Group Type EXPERIMENTAL

NeuroVax

Intervention Type BIOLOGICAL

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 a surfactant system designed to make a water-in-oil emulsion

Group Type PLACEBO_COMPARATOR

IFA Incomplete Freund's Adjuvant

Intervention Type BIOLOGICAL

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

Interventions

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NeuroVax

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

Intervention Type 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

Intervention Type BIOLOGICAL

Other Intervention Names

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IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immune Response BioPharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard M Bartholomew, Ph.D

Role: STUDY_DIRECTOR

Immune Response BioPharma, Inc.

Locations

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CRO

San Diego, California, United States

Site Status

Countries

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United States

Central Contacts

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Richard M Bartholomew, Ph.D

Role: CONTACT

1-858-414-4664

Facility Contacts

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Richard M Bartholomew, PhD

Role: primary

858-414-4664

Related Links

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http://www.immuneresponse.net

Immune Response BioPharma, Inc.

Other Identifiers

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IR902-007

Identifier Type: -

Identifier Source: org_study_id

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