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Fit for purpose? A case study: validation of immunological endpoint assays for the detection of cellular and humoral responses to anti-tumour DNA fusion vaccines.

Fit for purpose? A case study: validation of immunological endpoint assays for the detection of cellular and humoral responses to anti-tumour DNA fusion vaccines.
Fit for purpose? A case study: validation of immunological endpoint assays for the detection of cellular and humoral responses to anti-tumour DNA fusion vaccines.
Clinical trials are governed by an increasingly stringent regulatory framework, which applies to all levels of trial conduct. Study critical immunological endpoints, which define success or failure in early phase clinical immunological trials, require formal pre-trial validation. In this case study, we describe the assay validation process, during which the sensitivity, and precision of immunological endpoint assays were defined. The purpose was the evaluation of two multicentre phase I/II clinical trials from our unit in Southampton, UK, which assess the effects of DNA fusion vaccines on immune responses in HLA-A2+ patients with carcinoembryonic antigen (CEA)-expressing malignancies and prostate cancer. Validated immunomonitoring is being performed using ELISA and IFNgamma ELISPOTs to assess humoral and cellular responses to the vaccines over time. The validated primary endpoint assay, a peptide-specific CD8+ IFNgamma ELISPOT, was tested in a pre-trial study and found to be suitable for the detection of low frequency naturally occurring CEA- and prostate-derived tumour-antigen-specific T cells in patients with CEA-expressing malignancies and prostate cancer.
immunotherapy, immunomonitoring, assay validation, DNA fusion vaccine, CEA, PSMA
0340-7004
789-800
Mander, Ann
2fcb3a33-6bb8-4463-8b06-79cd508e9d80
Chowdhury, Ferdousi
0af499d4-17c5-40cf-9426-0d509ab82595
Low, Lindsey
ec25c30c-369d-4516-b872-4cb3c135c10a
Ottensmeier, Christian H.
42b8a398-baac-4843-a3d6-056225675797
Mander, Ann
2fcb3a33-6bb8-4463-8b06-79cd508e9d80
Chowdhury, Ferdousi
0af499d4-17c5-40cf-9426-0d509ab82595
Low, Lindsey
ec25c30c-369d-4516-b872-4cb3c135c10a
Ottensmeier, Christian H.
42b8a398-baac-4843-a3d6-056225675797

Mander, Ann, Chowdhury, Ferdousi, Low, Lindsey and Ottensmeier, Christian H. (2009) Fit for purpose? A case study: validation of immunological endpoint assays for the detection of cellular and humoral responses to anti-tumour DNA fusion vaccines. Cancer Immunology Immunotherapy, 58 (5), 789-800. (doi:10.1007/s00262-008-0633-z).

Record type: Article

Abstract

Clinical trials are governed by an increasingly stringent regulatory framework, which applies to all levels of trial conduct. Study critical immunological endpoints, which define success or failure in early phase clinical immunological trials, require formal pre-trial validation. In this case study, we describe the assay validation process, during which the sensitivity, and precision of immunological endpoint assays were defined. The purpose was the evaluation of two multicentre phase I/II clinical trials from our unit in Southampton, UK, which assess the effects of DNA fusion vaccines on immune responses in HLA-A2+ patients with carcinoembryonic antigen (CEA)-expressing malignancies and prostate cancer. Validated immunomonitoring is being performed using ELISA and IFNgamma ELISPOTs to assess humoral and cellular responses to the vaccines over time. The validated primary endpoint assay, a peptide-specific CD8+ IFNgamma ELISPOT, was tested in a pre-trial study and found to be suitable for the detection of low frequency naturally occurring CEA- and prostate-derived tumour-antigen-specific T cells in patients with CEA-expressing malignancies and prostate cancer.

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More information

Published date: May 2009
Keywords: immunotherapy, immunomonitoring, assay validation, DNA fusion vaccine, CEA, PSMA

Identifiers

Local EPrints ID: 147685
URI: http://eprints.soton.ac.uk/id/eprint/147685
ISSN: 0340-7004
PURE UUID: befb99b8-a7ee-4093-866f-823c3291e48f

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Date deposited: 26 Apr 2010 11:37
Last modified: 14 Mar 2024 00:59

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Contributors

Author: Ann Mander
Author: Ferdousi Chowdhury
Author: Lindsey Low

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