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- W2166092022 abstract "Itamar Raz and colleagues' report (Nov 24, p 1749)1Raz I Elias D Avron A Tamir M Metzger M Cohen IR β-cell function in new-onset type 1 diabetes and immunomodulation with a heat-shock protein peptide (DiaPep277): a randomised, double-blind, phase II trial.Lancet. 2001; 358: 1749-1753Summary Full Text Full Text PDF PubMed Scopus (462) Google Scholar of their study of β-cell function in new-onset type 1 diabetes and immunomodulation with a peptide from HSP60 heat-shock protein, p277, is interesting, but we have several issues to raise in response. In patients with new-onset type 1 diabetes treated with p277, stimulated C-peptide concentrations improved and insulin doses fell after 10 months. On the other hand, haemaglobin A1c values did not improve, which might have been expected with improved β-cell function. Raz and colleagues report average results only, and substantial SDs were ascertained—eg, at 10 months the SD of stimulated C-peptide (0·35) constituted 38% of the mean value of 0·93 nmol/L. The difference compared with the control mean is suggested to be significant (p=0·039). However, it would have been desirable to have seen, presented in a figure, the values for the individual patients. Since there must be a wide range, do the values have a Gaussian distribution, allowing the use of t tests? A beneficial effect of vaccination in an autoimmune disease such as type 1 diabetes might be seen only in some patients, whereas others at best show no difference. The question is whether vaccination raises concentrations of regulatory T cells only, or whether effector T cells are also induced. In a study of p277 treatment given to diabetes-prone nonobese diabetic mice, we reported no change in the rate of diabetes and, moreover, an acceleration of the disease after administration of the whole 65 kDa heat-shock protein.2Funda DP Hartoft-Nielsen M-L Kaas A Buschard K Effect of intrathymic administration of mycobacterial heat shock protein 65 and peptide p277 on the development of diabetes in NOD mice: caution required in vaccination studies.APMIS. 1998; 106: 1009-1016Crossref PubMed Scopus (11) Google Scholar Thus, when doing and presenting vaccination studies, it is as important to see the overall effect as it is to see how many patients display no effect, and, furthermore, it is essential to assess whether there is any risk of an adverse effect. Vaccination studies in type 1 diabetesAuthors' reply Full-Text PDF" @default.
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- W2166092022 date "2002-08-01" @default.
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- W2166092022 title "Vaccination studies in type 1 diabetes" @default.
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- W2166092022 doi "https://doi.org/10.1016/s0140-6736(02)09646-0" @default.
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