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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights

Study Summary

This trial is testing a new vaccine for Multiple Sclerosis in children to see if it is safe and effective.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
Secondary outcome measures
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%
Vomiting
20%
Other PAIN
20%
Flushing
20%
Dizziness/Lightheadedness
10%
Edema
10%
Constipation
10%
Other
10%
Stomatitis/Pharyngitis
10%
SGOT/SGPT
10%
Cough
10%
Dyspnea
10%
Hemoglobin
10%
Skin
10%
Mood
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Immune Response BioPharma, Inc.Lead Sponsor
4 Previous Clinical Trials
876 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
350 Patients Enrolled for Multiple Sclerosis
Richard M Bartholomew, Ph.DStudy DirectorImmune Response BioPharma, Inc.
2 Previous Clinical Trials
350 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
350 Patients Enrolled for Multiple Sclerosis

Media Library

NeuroVax (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02200718 — Phase 1
Multiple Sclerosis Research Study Groups: NeuroVax, IFA Incomplete Freund's Adjuvant
Multiple Sclerosis Clinical Trial 2023: NeuroVax Highlights & Side Effects. Trial Name: NCT02200718 — Phase 1
NeuroVax (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02200718 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this trial be considered an innovative research endeavor?

"NeuroVax has been a subject of clinical research since 2020, when Immune Response BioPharma, Inc. ran the first trial with 200 participants. Thereafter NeuroVax received Phase 2 & 3 drug approval; as it stands now, two active studies are taking place in one city and nation."

Answered by AI

Have researchers previously conducted research into NeuroVax?

"At the moment, two NeuroVax trials are operational with one study moving into Phase 3. With a majority of sites located in San Diego, California, there are still two other centres conducting research on this therapeutic intervention."

Answered by AI

Is this research endeavor still open to recruitment?

"Clinicaltrials.gov does not have any records of this trial actively recruiting participants, as the posting for it was first made on December 31st 2020 but then last edited on March 30th 2020. Nonetheless, 551 other clinical trials continue to search for volunteers."

Answered by AI

How many participants are part of this clinical investigation?

"This trial is currently not enrolling any new candidates. It was initially posted on December 31st 2020, and the last update occurred on March 30th 2020. If you would like to explore other studies, 549 trials related to multiple sclerosis are recruiting participants right now, along with 2 NeuroVax initiatives seeking volunteers."

Answered by AI

Is the age requirement for prospective participants above 25 years?

"This clinical trial only accepts participants that range in age from 5 to 17 years old."

Answered by AI

To what demographic is this clinical trial available?

"In order to be considered for this research project, participants must have a diagnosis of multiple sclerosis and lie between 5-17 years old. Presently approximately 12 patients are being recruited."

Answered by AI

Has NeuroVax been granted official sanction from the FDA?

"NeuroVax's safety is rated as a 1 based on limited available evidence, due to it being in the initial Phase 1 trial."

Answered by AI
~2 spots leftby Nov 2024