Multiple Sclerosis, Relapsing-RemittingPhase 1/2DESNCT00587691
Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
A Phase 1/2 study testing Tovaxin Autologous T Cell Vaccine in people with Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Secondary Progressive, run by Opexa Therapeutics, Inc. at 2 sites in United States.
Trial summary
The purpose of the study is 1) to study the safety and tolerability of escalating doses of myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of T Cell Vaccine ion the clinical course of MS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive
- What is being tested?
- Tovaxin Autologous T Cell Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2002to Dec 2008
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable MS disease within 30 days prior to enrollment
- EDSS Score between 2 and 8 inclusively
- Failed to respond to or cannot tolerate at least 1 or more of the currently approved drugs for MS.
Who cannot join
- Women who are pregnant or breast-feeding or who plan to become pregnant during the study
- Has taken immunomodulating drugs within 60 days prior to screening
- HIV positive
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bellaire Neurology
Bellaire, Texas, 77401
Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
The purpose of the study is 1) to study the safety and tolerability of escalating doses of myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of T Cell Vaccine ion the clinical course of MS.
Read the detailed description
The principle of TCV is similar to that of traditional microbial vaccination where attenuated infectious agents are used to stimulate protective immune responses. Because pathogentic autoreactive T cells are viewed as pathogens in T cell-mediated autoimmune diseases, they can be used, as a vaccine to prevent and treat the diseases in which they are able to induce.
- Being tested
- Tovaxin Autologous T Cell Vaccine
- Keywords
- Tovaxin, TCV, Autologous
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tovaxin Autologous T Cell VaccineBiological
Primary Series (x1): 4 subcutaneous injections (wks 0, 4, 12 and 20 with 52 week evaluable period.
Retreatment Series (x3): 3 subcutaneous injections (wks 0, 4, and 8) with 26-week evaluable periods.
Retreatment Series (x3): 5 subcutaneous injections (wks 0, 8, 26, 24 and 32) with 52-week evaluable periods.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | 6-9 million MRTC Receives: Biological: Tovaxin Autologous T Cell Vaccine |
| Dose Level 2 | Experimental | 30-45 million MRTC Receives: Biological: Tovaxin Autologous T Cell Vaccine |
| Dose Level 3 | Experimental | 60-90 million MRTC Receives: Biological: Tovaxin Autologous T Cell Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety and tolerability
Measured: Yearly Intervals
Secondary outcomes (3)
To assess changes in EDSS Scores
Measured: Yearly Intervals
To assess changes in the myelin-reactive profile in the blood
Measured: Yearly Intervals
To assess changes in the frequency of MS relapses
Measured: Yearly Intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJul 2002
- Primary completionJun 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opexa Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaye Thompson, PhD, Study director, Opexa Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587691
- Sponsor's protocol ID
- 2000-03
- Acronym
- DES
- Status last verified
- Jan 2017
- First submitted
- 21 Dec 2007
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
PubMed 11642613Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. doi: 10.1586/14760584.1.3.285.
PubMed 12901569Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. doi: 10.1007/pl00007867.
PubMed 11985389
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00587691
- Acronym / sponsor ID
- DES / 2000-03
- Keywords
- Tovaxin, TCV, Autologous
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Opexa Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Jan 2008 (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.
The purpose of the study is 1) to study the safety and tolerability of escalating doses of myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of T Cell Vaccine ion the clinical course of MS.
Detailed description
The principle of TCV is similar to that of traditional microbial vaccination where attenuated infectious agents are used to stimulate protective immune responses. Because pathogentic autoreactive T cells are viewed as pathogens in T cell-mediated autoimmune diseases, they can be used, as a vaccine to prevent and treat the diseases in which they are able to induce.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Biological: Tovaxin Autologous T Cell Vaccine6-9 million MRTC |
| Dose Level 2 | Experimental | Biological: Tovaxin Autologous T Cell Vaccine30-45 million MRTC |
| Dose Level 3 | Experimental | Biological: Tovaxin Autologous T Cell Vaccine60-90 million MRTC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable MS disease within 30 days prior to enrollment
- EDSS Score between 2 and 8 inclusively
- Failed to respond to or cannot tolerate at least 1 or more of the currently approved drugs for MS.
Key exclusion criteria (3 listed)
- Women who are pregnant or breast-feeding or who plan to become pregnant during the study
- Has taken immunomodulating drugs within 60 days prior to screening
- HIV positive
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 |
|---|---|---|
| Tovaxin Autologous T Cell VaccinePrimary Series (x1): 4 subcutaneous injections (wks 0, 4, 12 and 20 with 52 week evaluable period. Retreatment Series (x3): 3 subcutaneous injections (wks 0, 4, and 8) with 26-week evaluable periods. Retreatment Series (x3): 5 subcutaneous injections (wks 0, 8, 26, 24 and 32) with 52-week evaluable periods. | Biological | Dose Level 1, Dose Level 2, Dose Level 3 |
Primary outcome
Evaluation of safety and tolerability
Time frame: Yearly Intervals
3 secondary outcomes
To assess changes in EDSS Scores
Time frame: Yearly Intervals
To assess changes in the myelin-reactive profile in the blood
Time frame: Yearly Intervals
To assess changes in the frequency of MS relapses
Time frame: Yearly Intervals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Background: PubMed 11642613Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
- Background: PubMed 12901569Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. doi: 10.1586/14760584.1.3.285.
- Background: PubMed 11985389Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. doi: 10.1007/pl00007867.
- Individual participant dataSharing planned: No
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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.
Jaye Thompson, PhD study director
Opexa Therapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tovaxin Autologous T Cell Vaccine in people with Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Secondary Progressive, run by Opexa Therapeutics, Inc. at 2 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of safety and tolerability (time frame: Yearly Intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00587691, which also lists 3 linked publications.
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 11 Jan 2017.