Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057499
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2003-04-03
Brief Title:
Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Autoantigen Vaccination in Human Type 1 Newly Diagnosed Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 An autoimmune disease is a disease in which the bodys 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
T1DM is an autoimmune disease An autoimmune disease is a disease in which the bodys 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAIT BD012 | None | None | None |