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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the NeuroVax treatment for multiple sclerosis?

The NeuroVax vaccine, which is being tested for multiple sclerosis, uses a combination of T-cell receptor peptides in a substance called incomplete Freund's adjuvant. While specific effectiveness data for multiple sclerosis is not provided, similar vaccine platforms have shown strong immune responses in other conditions, like ovarian cancer, suggesting potential for NeuroVax to stimulate immune responses in multiple sclerosis as well. ^{1 2 3 4 5}

How is the NeuroVax treatment different from other treatments for multiple sclerosis?

NeuroVax is unique because it is a vaccine specifically designed to help the immune system manage multiple sclerosis, unlike other treatments that may suppress the immune system. This approach aims to protect against infections while potentially reducing disease activity. ^{6 7 8 9 10}

Research Team

Richard M Bartholomew, Ph.D

Principal Investigator

Immune Response BioPharma, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Technology evaluation: NeuroVax, Immune Response Corp. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Survivin-targeted immunotherapy drives robust polyfunctional T cell generation and differentiation in advanced ovarian cancer patients. [2021]

3. United States 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. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of IMVAMUNE, a promising candidate as a third generation smallpox vaccine. [2006]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized phase II trial to compare safety and immunogenicity of the MVA-BN smallpox vaccine at various doses in adults with a history of AIDS. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Protecting people with multiple sclerosis through vaccination. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Safety of anti-varicella zoster virus vaccination in patients with multiple sclerosis treated with natalizumab: A case series. [2023]

8. France pubmed.ncbi.nlm.nih.gov

[Central nervous system demyelinating disease following hepatitis B vaccination with GenHevac B. Review of ten years of spontaneous notifications (1989-1998)]. [2016]

9. England pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of autologous T-cell therapy in multiple sclerosis: subset analysis and implications for trial design. [2012]

10. England pubmed.ncbi.nlm.nih.gov

Vaccinations in patients with multiple sclerosis: A Delphi consensus statement. [2021]