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Guidelines for assessing immunocompetency in clinical trials for autoimmune diseases.

Publication ,  Journal Article
Looney, RJ; Diamond, B; Holers, VM; Levesque, MC; Moreland, L; Nahm, MH; St Clair, EW; Autoimmunity Centers of Excellence Immunocompetency Committee,
Published in: Clin Immunol
June 2007

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.

Duke Scholars

Published In

Clin Immunol

DOI

ISSN

1521-6616

Publication Date

June 2007

Volume

123

Issue

3

Start / End Page

235 / 243

Location

United States

Related Subject Headings

  • Virus Diseases
  • Immunosuppressive Agents
  • Immunology
  • Immunocompromised Host
  • Immunocompetence
  • Immunity, Innate
  • Immunity, Cellular
  • Humans
  • Communicable Diseases
  • Clinical Trials as Topic
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Looney, R. J., Diamond, B., Holers, V. M., Levesque, M. C., Moreland, L., Nahm, M. H., … Autoimmunity Centers of Excellence Immunocompetency Committee, . (2007). Guidelines for assessing immunocompetency in clinical trials for autoimmune diseases. Clin Immunol, 123(3), 235–243. https://doi.org/10.1016/j.clim.2007.01.001
Looney, R John, Betty Diamond, V Michael Holers, Marc C. Levesque, Larry Moreland, Moon H. Nahm, E William St Clair, and E William Autoimmunity Centers of Excellence Immunocompetency Committee. “Guidelines for assessing immunocompetency in clinical trials for autoimmune diseases.Clin Immunol 123, no. 3 (June 2007): 235–43. https://doi.org/10.1016/j.clim.2007.01.001.
Looney RJ, Diamond B, Holers VM, Levesque MC, Moreland L, Nahm MH, et al. Guidelines for assessing immunocompetency in clinical trials for autoimmune diseases. Clin Immunol. 2007 Jun;123(3):235–43.
Looney, R. John, et al. “Guidelines for assessing immunocompetency in clinical trials for autoimmune diseases.Clin Immunol, vol. 123, no. 3, June 2007, pp. 235–43. Pubmed, doi:10.1016/j.clim.2007.01.001.
Looney RJ, Diamond B, Holers VM, Levesque MC, Moreland L, Nahm MH, St Clair EW, Autoimmunity Centers of Excellence Immunocompetency Committee. Guidelines for assessing immunocompetency in clinical trials for autoimmune diseases. Clin Immunol. 2007 Jun;123(3):235–243.
Journal cover image

Published In

Clin Immunol

DOI

ISSN

1521-6616

Publication Date

June 2007

Volume

123

Issue

3

Start / End Page

235 / 243

Location

United States

Related Subject Headings

  • Virus Diseases
  • Immunosuppressive Agents
  • Immunology
  • Immunocompromised Host
  • Immunocompetence
  • Immunity, Innate
  • Immunity, Cellular
  • Humans
  • Communicable Diseases
  • Clinical Trials as Topic