Multiple SclerosisPhase 1NCT02200718
A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
A Phase 1 study testing NeuroVax and IFA Incomplete Freund's Adjuvant in people with Multiple Sclerosis, run by Immune Response BioPharma, Inc. at 1 site in United States.
Trial summary
A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \& efficacy Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- NeuroVax and IFA Incomplete Freund's Adjuvant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2020to 9 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Subjects currently prescribed Campath or Lemtrada
Trial locations and contacts
1 site in 1 country.
United States1 site
CRO
San Diego, California, 92129
Richard M Bartholomew, PhD, 858-414-4664, Richardmbartholomew@gmail.com
About this study
Official title: A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \& efficacy
Read the detailed description
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
- Multiple Sclerosis
- Being tested
- NeuroVax, IFA Incomplete Freund's Adjuvant
- Keywords
- Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroVaxBiological
Also called IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
IFA Incomplete Freund's AdjuvantBiological
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
| Study group | Role | What they receive |
|---|---|---|
| NeuroVax | Experimental | NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant Receives: Biological: NeuroVax |
| IFA Incomplete Freund's Adjuvant | Placebo comparator | 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 Receives: Biological: IFA Incomplete Freund's Adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI \& to compare the increases of WBC white blood cell counts in subjects in the treatment groups with Pediatric MS
Measured: 26 Weeks
Secondary outcomes (3)
A Secondary clinical endpoint is the measurement of FOXP3+ expression
Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups
Measured: 26 Weeks
A Secondary clinical endpoint is the measurment of EDSS scores
To compare between treatment groups the Measures of neurologic disability EDSS scores utilizing the Kurtzke scale, Patients will be assessed using the EDSS, a 25-foot timed walk, and a nine-hole peg test assessments at weeks 0, 4, 8, 12, 16, 20 \& 26 visit then exit the study.
Measured: 26 Weeks
A Secondary clinical endpoint is the measurement of clinical relapses
To compare the Analysis of clinical relapses between the treatment groups of Pediatric MS subjects at week 26
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study start31 Dec 2020 (estimated)
- Primary completion9 Nov 2024 (estimated)
- Study completion9 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immune Response BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard M Bartholomew, Ph.D, Study director, Immune Response BioPharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200718
- Sponsor's protocol ID
- IR902-007
- Status last verified
- Mar 2020
- First submitted
- 17 Jul 2014
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02200718
- Acronym / sponsor ID
- IR902-007
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Immune Response BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2020 (estimated)
- Primary completion
- 9 Nov 2024 (estimated)
- Study completion
- 9 Nov 2024 (estimated)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \& efficacy
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroVax | Experimental | Biological: NeuroVaxNeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant |
| IFA Incomplete Freund's Adjuvant | Placebo comparator | Biological: IFA Incomplete Freund's AdjuvantIFA 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 may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects currently prescribed Campath or Lemtrada
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroVaxAlso: IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1 | Biological | NeuroVax |
| IFA Incomplete Freund's AdjuvantIFA 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 | Biological | IFA Incomplete Freund's Adjuvant |
Primary outcome
The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
Time frame: 26 Weeks
The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI \& to compare the increases of WBC white blood cell counts in subjects in the treatment groups with Pediatric MS
3 secondary outcomes
A Secondary clinical endpoint is the measurement of FOXP3+ expression
Time frame: 26 Weeks
A Secondary clinical endpoint is the measurment of EDSS scores
Time frame: 26 Weeks
A Secondary clinical endpoint is the measurement of clinical relapses
Time frame: 26 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard M Bartholomew, Ph.D study director
Immune Response BioPharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NeuroVax and IFA Incomplete Freund's Adjuvant in people with Multiple Sclerosis, run by Immune Response BioPharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard M Bartholomew, Ph.D (1-858-414-4664, Richardmbartholomew@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups (time frame: 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.