Trial reportJournal of autoimmunity2010
Autoantigen-specific regulatory T cells induced in patients with type 1 diabetes mellitus by insulin B-chain immunotherapy.
Trial report in Journal of autoimmunity, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00057499 (Autoantigen Vaccination in Human Type 1 Newly Diagnosed Diabetes Mellitus), which is not on this map. Cited by 58 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Autoantigen Vaccination in Human Type 1 Newly Diagnosed Diabetes Mellitus
Who cites it
58 citing papers in PubMed, 1 synthesis or guideline pooled it, 122 citations in OpenAlex.
- Antigen-based immunotherapies do not prevent progression of recent-onset autoimmune diabetes: a systematic review and meta-analysis.Endocrine · 2016Pooled it
- Trial
- GAD autoantibody epitope pattern after GAD-alum treatment in children and adolescents with type 1 diabetes.Pediatric diabetes · 2012Trial
- Review
- Cell-based therapies for the treatment of rheumatoid arthritis.Immunity, inflammation and disease · 2023Review
- Delivery route considerations for designing antigen-specific biomaterial strategies to combat autoimmunity.Advanced nanobiomed research · 2023Article
- Monitoring immunomodulation strategies in type 1 diabetes.Frontiers in immunology · 2023Review
- Mechanisms and therapeutic strategies of immune checkpoint molecules and regulators in type 1 diabetes.Frontiers in endocrinology · 2022Review
- Safety of the use of gold nanoparticles conjugated with proinsulin peptide and administered by hollow microneedles as an immunotherapy in type 1 diabetes.Immunotherapy advances · 2022Article
- Potential Therapeutic Application of Regulatory T Cells in Diabetes Mellitus Type 1.International journal of molecular sciences · 2021Review
- Biologia Futura: Emerging antigen-specific therapies for autoimmune diseases.Biologia futura · 2021Review
- Function and Role of Regulatory T Cells in Rheumatoid Arthritis.Frontiers in immunology · 2021Review
- A Novel Quantitative Approach to Staging and Assessing Recovery from Type 1 Diabetes Mellitus: The Type 1 Diabetes Mellitus Metabolic Recovery Index.International journal of molecular sciences · 2020Article
- Tolerogenic vaccine composited with islet-derived multipeptides and cyclosporin A induces pTreg and prevents Type 1 diabetes in murine model.Human vaccines & immunotherapeutics · 2020Article
- Induction of Antigen-Specific Tolerance in T Cell Mediated Diseases.Frontiers in immunology · 2020Review
- Tolerising cellular therapies: what is their promise for autoimmune disease?Annals of the rheumatic diseases · 2019Review
- Why Don't We Have a Vaccine Against Autoimmune Diseases? - A Review.Journal of clinical & cellular immunology · 2019Article
- Soluble antigen arrays disarm antigen-specific B cells to promote lasting immune tolerance in experimental autoimmune encephalomyelitis.Journal of autoimmunity · 2018Article
- Harnessing the power of regulatory T-cells to control autoimmune diabetes: overview and perspective.Immunology · 2018Review
- Multipeptide-coupled nanoparticles induce tolerance in 'humanised' HLA-transgenic mice and inhibit diabetogenic CD8Diabetologia · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 7 institutions in 3 countries.
Funding
Abstract
There is a growing body of evidence to suggest that the autoimmunity observed in type 1 diabetes mellitus (T1DM) is the result of an imbalance between autoaggressive and regulatory cell subsets. Therapeutics that supplement or enhance the existing regulatory subset are therefore a much sought after goal in this indication. Here, we report the results of a double blind, placebo controlled, phase I clinical trial of a novel antigen-specific therapeutic in 12 subjects with recently diagnosed T1DM. Our primary objective was to test its safety. The study drug, human insulin B-chain in incomplete Freund's adjuvant (IFA) was administered as a single intramuscular injection, with subjects followed for 2 years. All subjects completed therapy and all follow-up visits. The therapy was generally safe and well-tolerated. Mixed meal stimulated C-peptide responses, measured every 6 months, showed no statistical differences between arms. All patients vaccinated with the autoantigen, but none who received placebo, developed robust insulin-specific humoral and T cell responses. Up to two years following the single injection, in peripheral blood from subjects in the experimental arm, but not the control arm, insulin B-chain-specific CD4+ T cells could be isolated and cloned that showed phenotypic and functional characteristics of regulatory T cells. The induction of a lasting, robust immune response generating autoantigen-specific regulatory T cells provides strong justification for further testing of this therapy in type 1 diabetes. (clinicaltrials.gov identifier NCT00057499).
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.