Guidelines for assessing immunocompetency in clinical trials for autoimmune diseases.

Journal Article (Journal Article;Review)

Clinical trials testing the safety and efficacy of immunosuppressive agents for the treatment of autoimmune diseases should also be designed to evaluate immunocompetency. The most clinically relevant outcome for assessing immunocompetency is the infection rate. Therefore, a systematic approach to screening, monitoring, and reporting infections, modeled after the recommendations of the American Society of Transplantation, is presented. However, because the baseline infection rate in most autoimmune diseases is low, additional tests for immunocompetency should be considered. Evaluation of vaccine responses, an alternative clinically relevant approach, may be particularly useful. Other adjunctive approaches to evaluation of immunocompetency are discussed including immunization with non-vaccine neoantigens, surveillance of chronic viral infections, in vivo or in vitro assessment of cellular immunity, and analysis of innate immunity. Banking genetic material to allow genotyping should be considered particularly if a central repository for samples from different trials can be established.

Full Text

Duke Authors

Cited Authors

  • Looney, RJ; Diamond, B; Holers, VM; Levesque, MC; Moreland, L; Nahm, MH; St Clair, EW; Autoimmunity Centers of Excellence Immunocompetency Committee,

Published Date

  • June 2007

Published In

Volume / Issue

  • 123 / 3

Start / End Page

  • 235 - 243

PubMed ID

  • 17329169

Pubmed Central ID

  • PMC4564725

International Standard Serial Number (ISSN)

  • 1521-6616

Digital Object Identifier (DOI)

  • 10.1016/j.clim.2007.01.001


  • eng

Conference Location

  • United States