Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial
Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of autoimmunity, treatment with a target antigen can modulate aggressive autoimmunity. We aimed to assess whether immunisation with GAD formulated with aluminum hy...
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| Published in | The Lancet (British edition) Vol. 378; no. 9788; pp. 319 - 327 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Kidlington
Elsevier Ltd
23.07.2011
Elsevier Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of autoimmunity, treatment with a target antigen can modulate aggressive autoimmunity. We aimed to assess whether immunisation with GAD formulated with aluminum hydroxide (GAD-alum) would preserve insulin production in recent-onset type 1 diabetes.
Patients aged 3–45 years who had been diagnosed with type 1 diabetes for less than 100 days were enrolled from 15 sites in the USA and Canada, and randomly assigned to receive one of three treatments: three injections of 20 μg GAD-alum, two injections of 20 μg GAD-alum and one of alum, or 3 injections of alum. Injections were given subcutaneously at baseline, 4 weeks later, and 8 weeks after the second injection. The randomisation sequence was computer generated at the TrialNet coordinating centre. Patients and study personnel were masked to treatment assignment. The primary outcome was the baseline-adjusted geometric mean area under the curve (AUC) of serum C-peptide during the first 2 h of a 4-h mixed meal tolerance test at 1 year. Secondary outcomes included changes in glycated haemoglobin A
1c (HbA
1c) and insulin dose, and safety. Analysis included all randomised patients with known measurements. This trial is registered with
ClinicalTrials.gov, number
NCT00529399.
145 patients were enrolled and treated with GAD-alum (n=48), GAD-alum plus alum (n=49), or alum (n=48). At 1 year, the 2-h AUC of C-peptide, adjusted for age, sex, and baseline C-peptide value, was 0·412 nmol/L (95% CI 0·349–0·478) in the GAD-alum group, 0·382 nmol/L (0·322–0·446) in the GAD-alum plus alum group, and 0·413 nmol/L (0·351–0·477) in the alum group. The ratio of the population mean of the adjusted geometric mean 2-h AUC of C-peptide was 0·998 (95% CI 0·779–1·22; p=0·98) for GAD-alum versus alum, and 0·926 (0·720–1·13; p=0·50) for GAD-alum plus alum versus alum. HbA
1c, insulin use, and the occurrence and severity of adverse events did not differ between groups.
Antigen-based immunotherapy therapy with two or three doses of subcutaneous GAD-alum across 4–12 weeks does not alter the course of loss of insulin secretion during 1 year in patients with recently diagnosed type 1 diabetes. Although antigen-based therapy is a highly desirable treatment and is effective in animal models, translation to human autoimmune disease remains a challenge.
US National Institutes of Health. |
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| AbstractList | Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of autoimmunity, treatment with a target antigen can modulate aggressive autoimmunity. We aimed to assess whether immunisation with GAD formulated with aluminum hydroxide (GAD-alum) would preserve insulin production in recent-onset type 1 diabetes.
Patients aged 3–45 years who had been diagnosed with type 1 diabetes for less than 100 days were enrolled from 15 sites in the USA and Canada, and randomly assigned to receive one of three treatments: three injections of 20 μg GAD-alum, two injections of 20 μg GAD-alum and one of alum, or 3 injections of alum. Injections were given subcutaneously at baseline, 4 weeks later, and 8 weeks after the second injection. The randomisation sequence was computer generated at the TrialNet coordinating centre. Patients and study personnel were masked to treatment assignment. The primary outcome was the baseline-adjusted geometric mean area under the curve (AUC) of serum C-peptide during the first 2 h of a 4-h mixed meal tolerance test at 1 year. Secondary outcomes included changes in glycated haemoglobin A
1c (HbA
1c) and insulin dose, and safety. Analysis included all randomised patients with known measurements. This trial is registered with
ClinicalTrials.gov, number
NCT00529399.
145 patients were enrolled and treated with GAD-alum (n=48), GAD-alum plus alum (n=49), or alum (n=48). At 1 year, the 2-h AUC of C-peptide, adjusted for age, sex, and baseline C-peptide value, was 0·412 nmol/L (95% CI 0·349–0·478) in the GAD-alum group, 0·382 nmol/L (0·322–0·446) in the GAD-alum plus alum group, and 0·413 nmol/L (0·351–0·477) in the alum group. The ratio of the population mean of the adjusted geometric mean 2-h AUC of C-peptide was 0·998 (95% CI 0·779–1·22; p=0·98) for GAD-alum versus alum, and 0·926 (0·720–1·13; p=0·50) for GAD-alum plus alum versus alum. HbA
1c, insulin use, and the occurrence and severity of adverse events did not differ between groups.
Antigen-based immunotherapy therapy with two or three doses of subcutaneous GAD-alum across 4–12 weeks does not alter the course of loss of insulin secretion during 1 year in patients with recently diagnosed type 1 diabetes. Although antigen-based therapy is a highly desirable treatment and is effective in animal models, translation to human autoimmune disease remains a challenge.
US National Institutes of Health. Summary Background Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of autoimmunity, treatment with a target antigen can modulate aggressive autoimmunity. We aimed to assess whether immunisation with GAD formulated with aluminum hydroxide (GAD-alum) would preserve insulin production in recent-onset type 1 diabetes. Methods Patients aged 3–45 years who had been diagnosed with type 1 diabetes for less than 100 days were enrolled from 15 sites in the USA and Canada, and randomly assigned to receive one of three treatments: three injections of 20 μg GAD-alum, two injections of 20 μg GAD-alum and one of alum, or 3 injections of alum. Injections were given subcutaneously at baseline, 4 weeks later, and 8 weeks after the second injection. The randomisation sequence was computer generated at the TrialNet coordinating centre. Patients and study personnel were masked to treatment assignment. The primary outcome was the baseline-adjusted geometric mean area under the curve (AUC) of serum C-peptide during the first 2 h of a 4-h mixed meal tolerance test at 1 year. Secondary outcomes included changes in glycated haemoglobin A1c (HbA1c ) and insulin dose, and safety. Analysis included all randomised patients with known measurements. This trial is registered with ClinicalTrials.gov , number NCT00529399. Findings 145 patients were enrolled and treated with GAD-alum (n=48), GAD-alum plus alum (n=49), or alum (n=48). At 1 year, the 2-h AUC of C-peptide, adjusted for age, sex, and baseline C-peptide value, was 0·412 nmol/L (95% CI 0·349–0·478) in the GAD-alum group, 0·382 nmol/L (0·322–0·446) in the GAD-alum plus alum group, and 0·413 nmol/L (0·351–0·477) in the alum group. The ratio of the population mean of the adjusted geometric mean 2-h AUC of C-peptide was 0·998 (95% CI 0·779–1·22; p=0·98) for GAD-alum versus alum, and 0·926 (0·720–1·13; p=0·50) for GAD-alum plus alum versus alum. HbA1c , insulin use, and the occurrence and severity of adverse events did not differ between groups. Interpretation Antigen-based immunotherapy therapy with two or three doses of subcutaneous GAD-alum across 4–12 weeks does not alter the course of loss of insulin secretion during 1 year in patients with recently diagnosed type 1 diabetes. Although antigen-based therapy is a highly desirable treatment and is effective in animal models, translation to human autoimmune disease remains a challenge. Funding US National Institutes of Health. Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of autoimmunity, treatment with a target antigen can modulate aggressive autoimmunity. We aimed to assess whether immunisation with GAD formulated with aluminum hydroxide (GAD-alum) would preserve insulin production in recent-onset type 1 diabetes. Methods: Patients aged 3-45 years who had been diagnosed with type 1 diabetes for less than 100 days were enrolled from 15 sites in the USA and Canada, and randomly assigned to receive one of three treatments: three injections of 20 mu g GAD-alum, two injections of 20 mu g GAD-alum and one of alum, or 3 injections of alum. Injections were given subcutaneously at baseline, 4 weeks later, and 8 weeks after the second injection. The randomisation sequence was computer generated at the TrialNet coordinating centre. Patients and study personnel were masked to treatment assignment. The primary outcome was the baseline-adjusted geometric mean area under the curve (AUC) of serum C-peptide during the first 2 h of a 4-h mixed meal tolerance test at 1 year. Secondary outcomes included changes in glycated haemoglobin A sub(1c (HbA) sub(1)c) and insulin dose, and safety. Analysis included all randomised patients with known measurements. This trial is registered with [inline image]ClinicalTrials.gov, number [inline image]NCT00529399. Findings: 145 patients were enrolled and treated with GAD-alum (n=48), GAD-alum plus alum (n=49), or alum (n=48). At 1 year, the 2-h AUC of C-peptide, adjusted for age, sex, and baseline C-peptide value, was 0 super(.412 nmol/L (95% CI 0) super(.)349-0 super(.478) in the GAD-alum group, 0) super(.)382 nmol/L (0 super(.322-0) super(.)446) in the GAD-alum plus alum group, and 0 super(.413 nmol/L (0) super(.)351-0 super(.477) in the alum group. The ratio of the population mean of the adjusted geometric mean 2-h AUC of C-peptide was 0) super(.)998 (95% CI 0 super(.779-1) super(.)22; p=0 super(.98) for GAD-alum versus alum, and 0) super(.)926 (0 super(.720-1) super(.)13; p=0 super(.50) for GAD-alum plus alum versus alum. HbA) sub(1)c, insulin use, and the occurrence and severity of adverse events did not differ between groups. Interpretation: Antigen-based immunotherapy therapy with two or three doses of subcutaneous GAD-alum across 4-12 weeks does not alter the course of loss of insulin secretion during 1 year in patients with recently diagnosed type 1 diabetes. Although antigen-based therapy is a highly desirable treatment and is effective in animal models, translation to human autoimmune disease remains a challenge. Funding: US National Institutes of Health. BACKGROUND: Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of autoimmunity, treatment with a target antigen can modulate aggressive autoimmunity. We aimed to assess whether immunisation with GAD formulated with aluminum hydroxide (GAD-alum) would preserve insulin production in recent-onset type 1 diabetes. METHODS: Patients aged 3–45 years who had been diagnosed with type 1 diabetes for less than 100 days were enrolled from 15 sites in the USA and Canada, and randomly assigned to receive one of three treatments: three injections of 20 μg GAD-alum, two injections of 20 μg GAD-alum and one of alum, or 3 injections of alum. Injections were given subcutaneously at baseline, 4 weeks later, and 8 weeks after the second injection. The randomisation sequence was computer generated at the TrialNet coordinating centre. Patients and study personnel were masked to treatment assignment. The primary outcome was the baseline-adjusted geometric mean area under the curve (AUC) of serum C-peptide during the first 2 h of a 4-h mixed meal tolerance test at 1 year. Secondary outcomes included changes in glycated haemoglobin A₁c (HbA₁c) and insulin dose, and safety. Analysis included all randomised patients with known measurements. This trial is registered with ClinicalTrials.gov, number NCT00529399. FINDINGS: 145 patients were enrolled and treated with GAD-alum (n=48), GAD-alum plus alum (n=49), or alum (n=48). At 1 year, the 2-h AUC of C-peptide, adjusted for age, sex, and baseline C-peptide value, was 0·412 nmol/L (95% CI 0·349–0·478) in the GAD-alum group, 0·382 nmol/L (0·322–0·446) in the GAD-alum plus alum group, and 0·413 nmol/L (0·351–0·477) in the alum group. The ratio of the population mean of the adjusted geometric mean 2-h AUC of C-peptide was 0·998 (95% CI 0·779–1·22; p=0·98) for GAD-alum versus alum, and 0·926 (0·720–1·13; p=0·50) for GAD-alum plus alum versus alum. HbA₁c, insulin use, and the occurrence and severity of adverse events did not differ between groups. INTERPRETATION: Antigen-based immunotherapy therapy with two or three doses of subcutaneous GAD-alum across 4–12 weeks does not alter the course of loss of insulin secretion during 1 year in patients with recently diagnosed type 1 diabetes. Although antigen-based therapy is a highly desirable treatment and is effective in animal models, translation to human autoimmune disease remains a challenge. FUNDING: US National Institutes of Health. Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of autoimmunity, treatment with a target antigen can modulate aggressive autoimmunity. We aimed to assess whether immunisation with GAD formulated with aluminum hydroxide (GAD-alum) would preserve insulin production in recent-onset type 1 diabetes. Patients aged 3-45 years who had been diagnosed with type 1 diabetes for less than 100 days were enrolled from 15 sites in the USA and Canada, and randomly assigned to receive one of three treatments: three injections of 20 μg GAD-alum, two injections of 20 μg GAD-alum and one of alum, or 3 injections of alum. Injections were given subcutaneously at baseline, 4 weeks later, and 8 weeks after the second injection. The randomisation sequence was computer generated at the TrialNet coordinating centre. Patients and study personnel were masked to treatment assignment. The primary outcome was the baseline-adjusted geometric mean area under the curve (AUC) of serum C-peptide during the first 2 h of a 4-h mixed meal tolerance test at 1 year. Secondary outcomes included changes in glycated haemoglobin A(1c) (HbA(1c)) and insulin dose, and safety. Analysis included all randomised patients with known measurements. This trial is registered with ClinicalTrials.gov, number NCT00529399. 145 patients were enrolled and treated with GAD-alum (n=48), GAD-alum plus alum (n=49), or alum (n=48). At 1 year, the 2-h AUC of C-peptide, adjusted for age, sex, and baseline C-peptide value, was 0·412 nmol/L (95% CI 0·349-0·478) in the GAD-alum group, 0·382 nmol/L (0·322-0·446) in the GAD-alum plus alum group, and 0·413 nmol/L (0·351-0·477) in the alum group. The ratio of the population mean of the adjusted geometric mean 2-h AUC of C-peptide was 0·998 (95% CI 0·779-1·22; p=0·98) for GAD-alum versus alum, and 0·926 (0·720-1·13; p=0·50) for GAD-alum plus alum versus alum. HbA(1c), insulin use, and the occurrence and severity of adverse events did not differ between groups. Antigen-based immunotherapy therapy with two or three doses of subcutaneous GAD-alum across 4-12 weeks does not alter the course of loss of insulin secretion during 1 year in patients with recently diagnosed type 1 diabetes. Although antigen-based therapy is a highly desirable treatment and is effective in animal models, translation to human autoimmune disease remains a challenge. US National Institutes of Health. Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of autoimmunity, treatment with a target antigen can modulate aggressive autoimmunity. We aimed to assess whether immunisation with GAD formulated with aluminum hydroxide (GAD-alum) would preserve insulin production in recent-onset type 1 diabetes.BACKGROUNDGlutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of autoimmunity, treatment with a target antigen can modulate aggressive autoimmunity. We aimed to assess whether immunisation with GAD formulated with aluminum hydroxide (GAD-alum) would preserve insulin production in recent-onset type 1 diabetes.Patients aged 3-45 years who had been diagnosed with type 1 diabetes for less than 100 days were enrolled from 15 sites in the USA and Canada, and randomly assigned to receive one of three treatments: three injections of 20 μg GAD-alum, two injections of 20 μg GAD-alum and one of alum, or 3 injections of alum. Injections were given subcutaneously at baseline, 4 weeks later, and 8 weeks after the second injection. The randomisation sequence was computer generated at the TrialNet coordinating centre. Patients and study personnel were masked to treatment assignment. The primary outcome was the baseline-adjusted geometric mean area under the curve (AUC) of serum C-peptide during the first 2 h of a 4-h mixed meal tolerance test at 1 year. Secondary outcomes included changes in glycated haemoglobin A(1c) (HbA(1c)) and insulin dose, and safety. Analysis included all randomised patients with known measurements. This trial is registered with ClinicalTrials.gov, number NCT00529399.METHODSPatients aged 3-45 years who had been diagnosed with type 1 diabetes for less than 100 days were enrolled from 15 sites in the USA and Canada, and randomly assigned to receive one of three treatments: three injections of 20 μg GAD-alum, two injections of 20 μg GAD-alum and one of alum, or 3 injections of alum. Injections were given subcutaneously at baseline, 4 weeks later, and 8 weeks after the second injection. The randomisation sequence was computer generated at the TrialNet coordinating centre. Patients and study personnel were masked to treatment assignment. The primary outcome was the baseline-adjusted geometric mean area under the curve (AUC) of serum C-peptide during the first 2 h of a 4-h mixed meal tolerance test at 1 year. Secondary outcomes included changes in glycated haemoglobin A(1c) (HbA(1c)) and insulin dose, and safety. Analysis included all randomised patients with known measurements. This trial is registered with ClinicalTrials.gov, number NCT00529399.145 patients were enrolled and treated with GAD-alum (n=48), GAD-alum plus alum (n=49), or alum (n=48). At 1 year, the 2-h AUC of C-peptide, adjusted for age, sex, and baseline C-peptide value, was 0·412 nmol/L (95% CI 0·349-0·478) in the GAD-alum group, 0·382 nmol/L (0·322-0·446) in the GAD-alum plus alum group, and 0·413 nmol/L (0·351-0·477) in the alum group. The ratio of the population mean of the adjusted geometric mean 2-h AUC of C-peptide was 0·998 (95% CI 0·779-1·22; p=0·98) for GAD-alum versus alum, and 0·926 (0·720-1·13; p=0·50) for GAD-alum plus alum versus alum. HbA(1c), insulin use, and the occurrence and severity of adverse events did not differ between groups.FINDINGS145 patients were enrolled and treated with GAD-alum (n=48), GAD-alum plus alum (n=49), or alum (n=48). At 1 year, the 2-h AUC of C-peptide, adjusted for age, sex, and baseline C-peptide value, was 0·412 nmol/L (95% CI 0·349-0·478) in the GAD-alum group, 0·382 nmol/L (0·322-0·446) in the GAD-alum plus alum group, and 0·413 nmol/L (0·351-0·477) in the alum group. The ratio of the population mean of the adjusted geometric mean 2-h AUC of C-peptide was 0·998 (95% CI 0·779-1·22; p=0·98) for GAD-alum versus alum, and 0·926 (0·720-1·13; p=0·50) for GAD-alum plus alum versus alum. HbA(1c), insulin use, and the occurrence and severity of adverse events did not differ between groups.Antigen-based immunotherapy therapy with two or three doses of subcutaneous GAD-alum across 4-12 weeks does not alter the course of loss of insulin secretion during 1 year in patients with recently diagnosed type 1 diabetes. Although antigen-based therapy is a highly desirable treatment and is effective in animal models, translation to human autoimmune disease remains a challenge.INTERPRETATIONAntigen-based immunotherapy therapy with two or three doses of subcutaneous GAD-alum across 4-12 weeks does not alter the course of loss of insulin secretion during 1 year in patients with recently diagnosed type 1 diabetes. Although antigen-based therapy is a highly desirable treatment and is effective in animal models, translation to human autoimmune disease remains a challenge.US National Institutes of Health.FUNDINGUS National Institutes of Health. Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of autoimmunity, treatment with a target antigen can modulate aggressive autoimmunity. We aimed to assess whether immunisation with GAD formulated with aluminum hydroxide (GAD-alum) would preserve insulin production in recent-onset type 1 diabetes. Patients aged 3-45 years who had been diagnosed with type 1 diabetes for less than 100 days were enrolled from 15 sites in the USA and Canada, and randomly assigned to receive one of three treatments: three injections of 20 µg GAD-alum, two injections of 20 µg GAD-alum and one of alum, or 3 injections of alum. Injections were given subcutaneously at baseline, 4 weeks later, and 8 weeks after the second injection. The randomisation sequence was computer generated at the TrialNet coordinating centre. Patients and study personnel were masked to treatment assignment. The primary outcome was the baseline-adjusted geometric mean area under the curve (AUC) of serum C-peptide during the first 2 h of a 4-h mixed meal tolerance test at 1 year. Secondary outcomes included changes in glycated haemoglobin A^sub 1c^ (HbA^sub 1c^) and insulin dose, and safety. Analysis included all randomised patients with known measurements. This trial is registered with ClinicalTrials.gov, number NCT00529399. 145 patients were enrolled and treated with GAD-alum (n=48), GAD-alum plus alum (n=49), or alum (n=48). At 1 year, the 2-h AUC of C-peptide, adjusted for age, sex, and baseline C-peptide value, was 0.412 nmol/L (95% CI 0.349-0.478) in the GAD-alum group, 0.382 nmol/L (0.322-0.446) in the GAD-alum plus alum group, and 0.413 nmol/L (0.351-0.477) in the alum group. The ratio of the population mean of the adjusted geometric mean 2-h AUC of C-peptide was 0.998 (95% CI 0.779-1.22; p=0.98) for GAD-alum versus alum, and 0.926 (0.720-1.13; p=0.50) for GAD-alum plus alum versus alum. HbA^sub 1c^, insulin use, and the occurrence and severity of adverse events did not differ between groups. Antigen-based immunotherapy therapy with two or three doses of subcutaneous GAD-alum across 4-12 weeks does not alter the course of loss of insulin secretion during 1 year in patients with recently diagnosed type 1 diabetes. Although antigen-based therapy is a highly desirable treatment and is effective in animal models, translation to human autoimmune disease remains a challenge. US National Institutes of Health. |
| Author | Marks, Jennifer B Schatz, Desmond Palmer, Jerry P Herold, Kevan C Orban, Tihamer Raskin, Philip Monzavi, Roshanak Rodriguez, Henry Wherrett, Diane K Skyler, Jay S Moran, Antoinette Bundy, Brian Goland, Robin Greenbaum, Carla J Krischer, Jeffrey P Becker, Dorothy J Wilson, Darrell M Gitelman, Stephen E DiMeglio, Linda A Gottlieb, Peter A |
| Author_xml | – sequence: 1 givenname: Diane K surname: Wherrett fullname: Wherrett, Diane K organization: Hospital for Sick Children, University of Toronto, Toronto, ON, Canada – sequence: 2 givenname: Brian surname: Bundy fullname: Bundy, Brian organization: University of South Florida, Tampa, FL, USA – sequence: 3 givenname: Dorothy J surname: Becker fullname: Becker, Dorothy J organization: University of Pittsburgh, Pittsburgh, PA, USA – sequence: 4 givenname: Linda A surname: DiMeglio fullname: DiMeglio, Linda A organization: Indiana University School of Medicine, Indianapolis, IN, USA – sequence: 5 givenname: Stephen E surname: Gitelman fullname: Gitelman, Stephen E organization: University of California San Francisco, San Francisco, CA, USA – sequence: 6 givenname: Robin surname: Goland fullname: Goland, Robin organization: Columbia University, New York, NY, USA – sequence: 7 givenname: Peter A surname: Gottlieb fullname: Gottlieb, Peter A organization: University of Colorado Barbara Davis Center for Childhood Diabetes, Aurora, CO, USA – sequence: 8 givenname: Carla J surname: Greenbaum fullname: Greenbaum, Carla J organization: Benaroya Research Institute, Seattle, WA, USA – sequence: 9 givenname: Kevan C surname: Herold fullname: Herold, Kevan C organization: Yale University School of Medicine, New Haven, CT, USA – sequence: 10 givenname: Jennifer B surname: Marks fullname: Marks, Jennifer B organization: Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL, USA – sequence: 11 givenname: Roshanak surname: Monzavi fullname: Monzavi, Roshanak organization: Children's Hospital Los Angeles, Los Angeles, CA, USA – sequence: 12 givenname: Antoinette surname: Moran fullname: Moran, Antoinette organization: University of Minnesota, Minneapolis, MN, USA – sequence: 13 givenname: Tihamer surname: Orban fullname: Orban, Tihamer organization: Joslin Diabetes Center, Boston, MA, USA – sequence: 14 givenname: Jerry P surname: Palmer fullname: Palmer, Jerry P organization: University of Washington School of Medicine, Seattle, WA, USA – sequence: 15 givenname: Philip surname: Raskin fullname: Raskin, Philip organization: University of Texas Southwestern Medical School, Dallas, TX, USA – sequence: 16 givenname: Henry surname: Rodriguez fullname: Rodriguez, Henry organization: Indiana University School of Medicine, Indianapolis, IN, USA – sequence: 17 givenname: Desmond surname: Schatz fullname: Schatz, Desmond organization: University of Florida, Gainesville, FL, USA – sequence: 18 givenname: Darrell M surname: Wilson fullname: Wilson, Darrell M organization: Stanford University, Stanford, CA, USA – sequence: 19 givenname: Jeffrey P surname: Krischer fullname: Krischer, Jeffrey P organization: University of South Florida, Tampa, FL, USA – sequence: 20 givenname: Jay S surname: Skyler fullname: Skyler, Jay S email: jskyler@miami.edu organization: Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL, USA |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24366115$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/21714999$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Zafonte, Stephanie J Schatz, Desmond Nepom, Gerald Eberhard, Christopher Siegelman, Mark Bingley, Penelope Insel, Richard Wagner, John Sosenko, Jay M Eisenbarth, George S Becker, Dorothy Marks, Jennifer Clare-Salzler, Michael Greenbaum, Carla J Kenyon, Norma S Thomas, James Adams, Timothy Mahon, Jeffrey Gottlieb, Peter Palmer, Jerry P Orban, Tihamer Hering, Bernard Parkman, Robertson Peyman, John Bourcier, Katarzyna Badias, Franz Brown, David Abbondondolo, Michael Goland, Robin Russell, William Fathman, C Garrison Jordan, Stanley Roncarolo, Maria Grazia Gitelman, Stephen Ziegler, Anette Chase, H Peter Fradkin, Judith Greenbaum, Carla Buckner, Jane Colman, Peter Wilson, Darrell M Cowie, Catherine Sherwin, Robert Kaufman, Francine R Lachin, John M Rodriguez, Henry Krause-Steinrauf, Heidi Ford, Julie Skyler, Jay S Moran, Antoinette Nanto-Salonen, Kirsti Savage, Peter Bundy, Brian Bluestone, Jeffrey Winter, William DiMeglio, Linda Herold, Kevan Pugliese, Alberto Grave, Gilman Peakman, Mark Wherrett, Diane Boonstra, Matthew Guillette, Heather Blum, Jan |
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Badias, Franz – sequence: 79 givenname: Craig surname: Beam fullname: Beam, Craig – sequence: 80 givenname: Matthew surname: Boonstra fullname: Boonstra, Matthew – sequence: 81 givenname: David surname: Boulware fullname: Boulware, David – sequence: 82 givenname: David surname: Cuthbertson fullname: Cuthbertson, David – sequence: 83 givenname: Christopher surname: Eberhard fullname: Eberhard, Christopher – sequence: 84 givenname: Julie surname: Ford fullname: Ford, Julie – sequence: 85 givenname: Jinin surname: Ginem fullname: Ginem, Jinin – sequence: 86 givenname: Heather surname: Guillette fullname: Guillette, Heather |
| Copyright | 2011 Elsevier Ltd Elsevier Ltd 2015 INIST-CNRS Copyright © 2011 Elsevier Ltd. All rights reserved. Copyright Elsevier Limited Jul 23-Jul 29, 2011 |
| Copyright_xml | – notice: 2011 Elsevier Ltd – notice: Elsevier Ltd – notice: 2015 INIST-CNRS – notice: Copyright © 2011 Elsevier Ltd. All rights reserved. – notice: Copyright Elsevier Limited Jul 23-Jul 29, 2011 |
| CorporateAuthor | the Type 1 Diabetes TrialNet GAD Study Group Type 1 Diabetes TrialNet GAD Study Group |
| CorporateAuthor_xml | – name: the Type 1 Diabetes TrialNet GAD Study Group – name: Type 1 Diabetes TrialNet GAD Study Group |
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| DOI | 10.1016/S0140-6736(11)60895-7 |
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| Keywords | Endocrinopathy Human Immunopathology Enzyme Vaccination Patient Autoimmune disease Lyases Glutamate decarboxylase Vaccine Antigen Medicine Carbon-carbon lyases Randomization Treatment Age of onset Type 1 diabetes Carboxy-lyases Double blind study Clinical trial |
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| Snippet | Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of autoimmunity,... Summary Background Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of... BACKGROUND: Glutamic acid decarboxylase (GAD) is a major target of the autoimmune response that occurs in type 1 diabetes mellitus. In animal models of... |
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| SubjectTerms | Adolescent Alum Aluminum Aluminum hydroxide Animal models antigens Antigens - immunology Antigens - therapeutic use Autoimmune Diseases - immunology Autoimmune Diseases - therapy autoimmunity Biological and medical sciences blood serum c-peptide Canada Child Child, Preschool Clinical trials Data collection Diabetes Diabetes Mellitus, Type 1 - immunology Diabetes Mellitus, Type 1 - therapy Diabetes. Impaired glucose tolerance Double-Blind Method Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance Female General aspects Glutamate Decarboxylase - immunology Glutamate Decarboxylase - therapeutic use glutamic acid hemoglobin human resources Humans Immunization Immunotherapy Immunotherapy, Active insulin secretion insulin-dependent diabetes mellitus Internal Medicine Lines of credit Male Medical sciences Middle Aged National Institutes of Health patients Pharmaceuticals United States vaccines Young Adult |
| Title | Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial |
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