NeuroVax Vaccine for Multiple Sclerosis

Overseen By Richard M Bartholomew, Ph.D

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Immune Response BioPharma, Inc.

Must not be taking: Campath, Lemtrada

Disqualifiers: Healthy volunteers, others

Compensation: Varies

Number of Visits: 7

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine called NeuroVax, designed to help children and teenagers with pediatric multiple sclerosis (MS), a condition where the immune system attacks the protective covering of nerves. The main goal is to determine if this vaccine is safe and effective. Participants will receive either the NeuroVax vaccine or a placebo, an inactive substance that resembles the treatment. The trial seeks young people with pediatric MS who have experienced at least two flare-ups in the past two years. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking Campath or Lemtrada.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that NeuroVax was well-tolerated in earlier studies. Most participants experienced only mild to moderate pain at the injection site, indicating the vaccine is generally safe for patients. No reports indicated that the treatment worsened the disease. This is encouraging for prospective trial participants, as past research suggests the treatment has been safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple sclerosis?

Researchers are excited about NeuroVax because it offers a novel approach for treating multiple sclerosis (MS). Unlike conventional treatments that primarily aim to reduce inflammation or modify the immune response, NeuroVax targets specific T-cell receptors using a Trivalent TCR Peptide Formulation. This formulation includes V Beta Peptides BV5S2, BV6S5, and BV13S1, which are emulsified in incomplete Freund's adjuvant, potentially providing a more targeted immune response. This specificity could lead to fewer side effects and improved efficacy compared to existing therapies, making it a promising option for MS patients.

What evidence suggests that the NeuroVax vaccine might be an effective treatment for multiple sclerosis?

Research suggests that NeuroVax, a treatment under study in this trial, may aid in treating multiple sclerosis by enhancing the body's immune response. Studies have shown that this vaccine increases the number of specific immune cells that regulate the immune system. These cells, known as IL-10-secreting TCR-reactive T cells, help calm an overactive immune system. This is crucial for conditions like multiple sclerosis, where the immune system mistakenly attacks the body's nerves. Although more research is needed, these early findings suggest that NeuroVax could potentially help manage symptoms and improve life for those with multiple sclerosis. ^{2 5 6 7 8}

Who Is on the Research Team?

Richard M Bartholomew, Ph.D

Principal Investigator

Immune Response BioPharma, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child has been diagnosed with Multiple Sclerosis.

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

I am between 5 and 17 years old.

Exclusion Criteria

I am currently taking Campath or Lemtrada.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NeuroVax or placebo for 26 weeks with assessments at weeks 0, 4, 8, 12, 16, 20, and 26

26 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IFA Incomplete Freund's Adjuvant
• NeuroVax

Trial Overview 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.

How Is the Trial Designed?

Group I: NeuroVax Experimental Treatment 1 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 Adjuvant Placebo Group 1 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

Who Is Running the Clinical Trial?

Immune Response BioPharma, Inc.

Lead Sponsor

Trials

5

Recruited

890+

Published Research Related to This Trial

The Phase I trial of the MVA-BN smallpox vaccine involved 86 healthy subjects and demonstrated that all participants in the highest dose group (10^8 TCID50) successfully developed an immune response (seroconversion).

The vaccine was well tolerated, with only mild to moderate injection site pain reported, suggesting that MVA-BN could be a safe and effective alternative to traditional smallpox vaccines, especially for individuals who cannot receive those vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of IMVAMUNE, a promising candidate as a third generation smallpox vaccine. Vollmar, J., Arndtz, N., Eckl, KM., et al.[2006]

The study involved 745 participants and demonstrated that the MVA-BN vaccine significantly boosts neutralizing antibody levels after both primary vaccination and a booster, indicating strong immunological memory.

No safety concerns were reported, suggesting that MVA-BN is a safe option for smallpox and monkeypox prevention, with effective long-term immune responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One- and Two-Dose Vaccinations With Modified Vaccinia Ankara-Bavarian Nordic Induce Durable B-Cell Memory Responses Comparable to Replicating Smallpox Vaccines. Ilchmann, H., Samy, N., Reichhardt, D., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02200718

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

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2433276/

Therapeutic vaccination with a trivalent T-cell receptor (TCR ... Our results clearly demonstrated that TCR peptide vaccination could induce transiently high frequencies of IL-10-secreting TCR-reactive T cells, an increase in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02149706

A Study of NeuroVax™, a Novel Therapeutic TCR Peptide ... The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores. Official Title. A Phase IIb Study of NeuroVax™, ...

4. withpower.com withpower.com/trial/phase-1-multiple-sclerosis-11-2020-508b6

NeuroVax Vaccine for Multiple Sclerosis · Info for Participants 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S187874792300939X

Therapeutic Advances and Future Prospects in ... TCR peptide vaccination in multiple sclerosis: boosting a deficient natural regulatory network that may involve TCR-specific CD4 + CD25+ Treg cells. Curr ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5976685/

Beyond the Magic Bullet: Current Progress of Therapeutic ... Administration of both peptides was safe and did not worsen the disease course following both administration routes [27]. Moreover, a peptide-specific immune ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2817477

Vaccine Safety and Immunogenicity in Patients With ... In this cohort study of 60 patients with MS treated with natalizumab, seroprotection rates exceeded 90% for hepatitis A, hepatitis B, and/or messenger RNA ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7157658/

Infections, Vaccines and Autoimmunity: A Multiple Sclerosis ... The core of any post-marketing vaccine safety surveillance includes monitoring for adverse events following immunization (AEFI). Events that ...