Insulin-dependent Diabetes MellitusPhase 1NCT00057499
Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics
A Phase 1 study testing IBC-VS01 in people with Insulin-dependent Diabetes Mellitus and Diabetes Mellitus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused by the destruction of insulin-producing cells in the pancreas. People with T1DM do not produce enough insulin, which is necessary for proper regulation of blood sugar levels. T1DM is an autoimmune disease. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Insulin-dependent Diabetes Mellitus, Diabetes Mellitus
- What is being tested?
- IBC-VS01
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2003to Mar 2007
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with type 1 diabetes mellitus within 3 months prior to study entry
- Positive for IAA, GAD65, or IA2 antibodies OR positive for GAD65 or IA2 antibodies after 2 weeks of starting insulin treatment
Who cannot join
- History of treatment with any oral hypoglycemic agent for more than 3 months
- Ongoing use of medications known to influence glucose tolerance
- History of immunosuppressive or steroid therapy for more than 3 months within the 2 years prior to study entry
- Severe active liver, heart, kidney, or immunodeficiency disease that may limit life expectancy or may require immunosuppression during the study
- Prior complications related to routine vaccinations
- Prior participation in a trial for prevention of type 1 diabetes mellitus. Individuals who are known to have been in the placebo arm of a completed prevention trial are not excluded.
- Any condition that may interfere with a participant's ability to comply with the study
- Pregnancy or planned pregnancy within the time frame of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital
Boston, Massachusetts, 02115
Joslin Diabetes Center
Boston, Massachusetts, 02215
About this study
Official title: Autoantigen Vaccination in Human Type 1 Newly Diagnosed Diabetes Mellitus
Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused by the destruction of insulin-producing cells in the pancreas. People with T1DM do not produce enough insulin, which is necessary for proper regulation of blood sugar levels.
T1DM is an autoimmune disease. An autoimmune disease is a disease in which the body's immune system attacks the body itself. In addition to regulating blood sugar, insulin may have the ability to protect cells in the pancreas from attack by the immune system. This study will evaluate whether an insulin-based vaccine can protect cells from autoimmune destruction.
Study hypothesis: IFA-enhanced human insulin B-chain vaccination will lead to the arrest or slowing of the ongoing autoimmunity, and this will result in an appreciable difference in functioning B cell mass compared to the placebo treated group by the end of the study.
Read the detailed description
The vaccine in this study, IBC-VSO1, is a synthetic, metabolically inactive form of insulin designed to prevent pancreatic beta-cell destruction. It does not cause fluctuations in blood sugar. This study will evaluate whether the vaccine protects against autoimmune attack at the onset of T1DM, before pancreas function has deteriorated. This experimental treatment must occur early because 60% to 85% of beta-cells are already destroyed by the time of T1DM diagnosis. If beta-cell destruction can be halted, a prolonged remission period after diagnosis may occur, with a subsequent delay in diabetes-related complications.
Participants must have been diagnosed with T1DM for no more than 3 months at the time of enrollment in this study. Participants will be randomly assigned to either a vaccine group or a control group. Participants in the vaccine group will receive one injection of IBC-VS01; participants in the control group will receive a placebo. Participants will then be monitored for 2 years. Participants will have ten follow-up visits, which will include blood tests for immunological and genetic analysis. Throughout the study, metabolic tests will also be performed to measure the remaining capacity of self insulin production of the body.
- Being tested
- IBC-VS01, IBC-VS01 placebo
- Keywords
- Juvenile diabetes, Diabetes, Insulin, Vaccine, Type 1 Diabetes, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBC-VS01Biological
IBC-VS01
IBC-VS01 placeboBiological
IBC-VS01 placebo
| Study group | Role | What they receive |
|---|---|---|
| IBC-VS01 vaccine | Experimental | IBC-VS01 vaccine is administered twice. Receives: Biological: IBC-VS01 |
| Control Group | Placebo comparator | IBC-VS01 placebo is administered twice Receives: Biological: IBC-VS01 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical endpoints including adverse events, local reactions, routine physical exams, insulin dose, and laboratory tests
Measured: Throughout study
Secondary outcomes (4)
C-peptide levels in response to mixed meal tolerance test
Measured: Throughout study
HbA1c, GAD65Ab, IAA, IA2Ab, GAD65Ab isotypes
Measured: Throughout study
CD4- and CD8- Va24JaQ+
Measured: Throughout study
T cells' secretion of IL-4 and Interferon (IFN)-gamma
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2003 (estimated)
- Study startMar 2003
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin-dependent Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Responsible party
- Sponsor
- Investigators
- Tihamer Orban, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057499
- Sponsor's protocol ID
- DAIT ITN012AI
- Other IDs
- DAIT BD012
- Status last verified
- Feb 2017
- First submitted
- 3 Apr 2003
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data access is provided to the public in : 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools available to researchers; and 2.) TrialShare, the Immune Tolerance Network (ITN) portal.
Publications
Orban T, Farkas K, Jalahej H, Kis J, Treszl A, Falk B, Reijonen H, Wolfsdorf J, Ricker A, Matthews JB, Tchao N, Sayre P, Bianchine P. Autoantigen-specific regulatory T cells induced in patients with type 1 diabetes mellitus by insulin B-chain immunotherapy. J Autoimmun. 2010 Jun;34(4):408-15. doi: 10.1016/j.jaut.2009.10.005.
PubMed 19931408
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoantigen Vaccination in Human Type 1 Newly Diagnosed Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00057499
- Acronym / sponsor ID
- DAIT ITN012AI
- Keywords
- Juvenile diabetes, Diabetes, Insulin, Vaccine, Type 1 Diabetes, Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Study start
- Mar 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 4 Apr 2003 (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.
Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused by the destruction of insulin-producing cells in the pancreas. People with T1DM do not produce enough insulin, which is necessary for proper regulation of blood sugar levels.
T1DM is an autoimmune disease. An autoimmune disease is a disease in which the body's immune system attacks the body itself. In addition to regulating blood sugar, insulin may have the ability to protect cells in the pancreas from attack by the immune system. This study will evaluate whether an insulin-based vaccine can protect cells from autoimmune destruction.
Study hypothesis: IFA-enhanced human insulin B-chain vaccination will lead to the arrest or slowing of the ongoing autoimmunity, and this will result in an appreciable difference in functioning B cell mass compared to the placebo treated group by the end of the study.
Detailed description
The vaccine in this study, IBC-VSO1, is a synthetic, metabolically inactive form of insulin designed to prevent pancreatic beta-cell destruction. It does not cause fluctuations in blood sugar. This study will evaluate whether the vaccine protects against autoimmune attack at the onset of T1DM, before pancreas function has deteriorated. This experimental treatment must occur early because 60% to 85% of beta-cells are already destroyed by the time of T1DM diagnosis. If beta-cell destruction can be halted, a prolonged remission period after diagnosis may occur, with a subsequent delay in diabetes-related complications.
Participants must have been diagnosed with T1DM for no more than 3 months at the time of enrollment in this study. Participants will be randomly assigned to either a vaccine group or a control group. Participants in the vaccine group will receive one injection of IBC-VS01; participants in the control group will receive a placebo. Participants will then be monitored for 2 years. Participants will have ten follow-up visits, which will include blood tests for immunological and genetic analysis. Throughout the study, metabolic tests will also be performed to measure the remaining capacity of self insulin production of the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBC-VS01 vaccine | Experimental | Biological: IBC-VS01IBC-VS01 vaccine is administered twice. |
| Control Group | Placebo comparator | Biological: IBC-VS01 placeboIBC-VS01 placebo is administered twice |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with type 1 diabetes mellitus within 3 months prior to study entry
- Positive for IAA, GAD65, or IA2 antibodies OR positive for GAD65 or IA2 antibodies after 2 weeks of starting insulin treatment
Key exclusion criteria (8 listed)
- History of treatment with any oral hypoglycemic agent for more than 3 months
- Ongoing use of medications known to influence glucose tolerance
- History of immunosuppressive or steroid therapy for more than 3 months within the 2 years prior to study entry
- Severe active liver, heart, kidney, or immunodeficiency disease that may limit life expectancy or may require immunosuppression during the study
- Prior complications related to routine vaccinations
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 |
|---|---|---|
| IBC-VS01IBC-VS01 | Biological | IBC-VS01 vaccine |
| IBC-VS01 placeboIBC-VS01 placebo | Biological | Control Group |
Primary outcome
Clinical endpoints including adverse events, local reactions, routine physical exams, insulin dose, and laboratory tests
Time frame: Throughout study
4 secondary outcomes
C-peptide levels in response to mixed meal tolerance test
Time frame: Throughout study
HbA1c, GAD65Ab, IAA, IA2Ab, GAD65Ab isotypes
Time frame: Throughout study
CD4- and CD8- Va24JaQ+
Time frame: Throughout study
T cells' secretion of IL-4 and Interferon (IFN)-gamma
Time frame: Throughout study
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 8 Feb 2017.
- Results publication: PubMed 19931408Orban T, Farkas K, Jalahej H, Kis J, Treszl A, Falk B, Reijonen H, Wolfsdorf J, Ricker A, Matthews JB, Tchao N, Sayre P, Bianchine P. Autoantigen-specific regulatory T cells induced in patients with type 1 diabetes mellitus by insulin B-chain immunotherapy. J Autoimmun. 2010 Jun;34(4):408-15. doi: 10.1016/j.jaut.2009.10.005.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT) websiteLink provided by the sponsor.
- Immune Tolerance Network (ITN) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data access is provided to the public in : 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools available to researchers; and 2.) TrialShare, the Immune Tolerance Network (ITN) portal.
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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.
Tihamer Orban, MD principal investigator
Joslin Diabetes Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBC-VS01 in people with Insulin-dependent Diabetes Mellitus and Diabetes Mellitus, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 2 inclusion and 8 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 8 Feb 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. 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?
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?
Clinical endpoints including adverse events, local reactions, routine physical exams, insulin dose, and laboratory tests (time frame: Throughout study). 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 NCT00057499, which also lists 1 linked publication.
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 8 Feb 2017.