What is the mechanism of action of this treatment?

Common treatments for Multiple Sclerosis (MS) often focus on modulating the immune system to reduce inflammation and prevent immune cells from attacking the myelin sheath. Interferon beta reduces inflammatory cell migration across the blood-brain barrier, while glatiramer acetate acts as a myelin decoy to divert immune attacks. Monoclonal antibodies like natalizumab and alemtuzumab target specific immune cells to prevent them from causing damage. These mechanisms are crucial for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression by addressing the underlying autoimmune response.

What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis that modulate the immune response include glatiramer acetate, dimethyl fumarate, and fingolimod. Glatiramer acetate can cause local injection site reactions, such as pain and redness, and systemic reactions like chest pain and palpitations. Dimethyl fumarate is associated with gastrointestinal issues, flushing, and a potential decrease in lymphocyte counts. Fingolimod's side effects include headache, elevated liver enzymes, bradyarrhythmia, macular edema, and an increased risk of infections, including viral and fungal infections. These treatments aim to reduce relapse rates and slow disease progression but come with varying side effect profiles that need to be managed under medical supervision.

What prior FDA approvals exist?

Several FDA-approved treatments for Multiple Sclerosis (MS) focus on modulating the immune response. Alemtuzumab, an antibody targeting CD52 on immune cells, is used for relapsing forms of MS and has shown efficacy in reducing relapse rates. Glatiramer acetate, which mimics myelin basic protein, induces specific T helper 2 type suppressor cells to reduce inflammation. Dimethyl fumarate (BG-12) is another oral medication that reduces relapse rates and new brain lesions by modulating the immune response. These treatments, like the TCR peptide vaccine NeuroVax™, aim to alter the immune system's activity to manage MS symptoms and progression.

What other types of research exist?

Promising novel alternatives to NeuroVax™ for Multiple Sclerosis patients include: 1) Extended interval dosing of natalizumab, which has been associated with a reduced risk of progressive multifocal leukoencephalopathy (PML). 2) Newer monoclonal antibodies such as ocrelizumab and ofatumumab, which target B-cells and have shown efficacy in reducing MS relapses. 3) Oral therapies like siponimod and ozanimod, which modulate the immune response by targeting sphingosine-1-phosphate receptors. These alternatives offer different mechanisms of action and administration routes, providing options for personalized treatment plans.

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Cancer Vaccine

NeuroVax Vaccine for Multiple Sclerosis

Phase 1

Waitlist Available

Research Sponsored by Immune Response BioPharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinically diagnosed Pediatric MS

Expanded Disability Status Scale (EDSS) <= score 6.5. 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

Must not have

Subjects currently prescribed Campath or Lemtrada

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Awards & highlights

Summary

This trial is testing NeuroVax™, a new vaccine designed to help children with multiple sclerosis. The vaccine works by teaching the immune system to better recognize and attack the cells that cause MS. The study aims to show that the vaccine is safe and effective for these young patients.

Who is the study for?

This trial is for children and teenagers aged 5 to 17 with Pediatric Multiple Sclerosis, who have had at least one relapse in the past year or two in the last two years. They should not be severely disabled by MS (EDSS score <=6.5) and must not currently be on Campath or Lemtrada treatments.

What is being tested?

The study tests NeuroVax™, a new TCR peptide vaccine, alongside IFA (Incomplete Freund's Adjuvant), to check their safety and effectiveness in treating Pediatric Multiple Sclerosis.

What are the potential side effects?

Potential side effects are not detailed here but may include typical vaccine-related reactions such as pain at injection site, fever, fatigue, and possibly autoimmune responses due to immune system activation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child has been diagnosed with Multiple Sclerosis.

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My MS has caused some disability but I can still walk, and I've had relapses recently.

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I am between 5 and 17 years old.

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I am between 5 and 17 years old.

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I have been diagnosed with Pediatric MS according to the McDonald criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking Campath or Lemtrada.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups

Secondary study objectives

A Secondary clinical endpoint is the measurement of FOXP3+ expression

A Secondary clinical endpoint is the measurement of clinical relapses

A Secondary clinical endpoint is the measurment of EDSS scores

Side effects data

From undefined Phase 2 trial • 40 Patients • NCT00003222

80%

Fatigue

60%

Injection Site Reaction

50%

Pruritus

50%

Nausea

50%

Rigors, Chills

40%

Fever

40%

Anorexia

40%

Diarrhea

40%

Headache

40%

Skin Rash/Urticaria

30%

Sweating

30%

Myalgia/Arthralgia

20%

Other PAIN

20%

Vomiting

20%

Flushing

20%

Dizziness/Lightheadedness

10%

Stomatitis/Pharyngitis

10%

Constipation

10%

Edema

10%

Other

10%

SGOT/SGPT

10%

Cough

10%

Dyspnea

10%

Hemoglobin

10%

Skin

10%

Mood

100%

80%

60%

40%

20%

Study treatment Arm

Peptides Pulsed on Dendritic Cells

Peptides in GMCSF-in-adjuvant

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NeuroVaxExperimental Treatment1 Intervention

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

Group II: IFA Incomplete Freund's AdjuvantPlacebo Group1 Intervention

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) often focus on modulating the immune system to reduce inflammation and prevent immune cells from attacking the myelin sheath. Interferon beta reduces inflammatory cell migration across the blood-brain barrier, while glatiramer acetate acts as a myelin decoy to divert immune attacks. Monoclonal antibodies like natalizumab and alemtuzumab target specific immune cells to prevent them from causing damage. These mechanisms are crucial for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression by addressing the underlying autoimmune response.

Efficacy of vaccination against influenza in patients with multiple sclerosis: The role of concomitant therapies.