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An in vitro functional assay to measure the biological activity of TB vaccine candidate H4-IC31

•In vitro assay measures biological activity of vaccine in human PBMC.•H4-IC31 stimulates PBMC IFNγ secretion in cells from BCG-immunized individual.•Assay serves as in vitro potency test for biological activity as part of product profile.•Assay discriminates responses to intact and heat treated mat... Full description

Journal Title: Vaccine 2019-05-16, Vol.37 (22), p.2960-2966
Main Author: Ming, Marin
Other Authors: Bernardo, Lidice , Williams, Kimberley , Kolattukudy, Pappachan , Kapoor, Nidhi , Chan, Leslie G , Pagnon, Anke , Piras, Fabienne , Su, Jin , Gajewska, Beata , Salha, Danielle , Gisonni-Lex, Lucy
Format: Electronic Article Electronic Article
Language: English
Subjects:
BCG
Quelle: Alma/SFX Local Collection
Publisher: Netherlands: Elsevier Ltd
ID: ISSN: 0264-410X
Link: https://www.ncbi.nlm.nih.gov/pubmed/31010716
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title: An in vitro functional assay to measure the biological activity of TB vaccine candidate H4-IC31
format: Article
creator:
  • Ming, Marin
  • Bernardo, Lidice
  • Williams, Kimberley
  • Kolattukudy, Pappachan
  • Kapoor, Nidhi
  • Chan, Leslie G
  • Pagnon, Anke
  • Piras, Fabienne
  • Su, Jin
  • Gajewska, Beata
  • Salha, Danielle
  • Gisonni-Lex, Lucy
subjects:
  • Assaying
  • Bacillus Calmette-Guerin vaccine
  • BCG
  • BCG vaccines
  • Biological activity
  • Blood & organ donations
  • Cell activation
  • Cell based potency
  • Cellular immune response
  • Clinical trials
  • Correlation analysis
  • Cytokines
  • Heat treatment
  • Immune response
  • Immune system
  • In vitro potency
  • Infections
  • Laboratory animals
  • Leukocytes (mononuclear)
  • Lymphocytes
  • Lymphocytes T
  • Manufacturers
  • Manufacturing
  • Medical research
  • Medicine, Experimental
  • Mycobacterium tuberculosis
  • Peptides
  • Peripheral blood mononuclear cells
  • Proteins
  • Quality assessment
  • Quality control
  • T cells
  • Tuberculosis
  • Tuberculosis vaccine
  • Tuberculosis vaccines
  • Vaccination
  • Vaccine evaluation
  • Vaccines
  • γ-Interferon
ispartof: Vaccine, 2019-05-16, Vol.37 (22), p.2960-2966
description: •In vitro assay measures biological activity of vaccine in human PBMC.•H4-IC31 stimulates PBMC IFNγ secretion in cells from BCG-immunized individual.•Assay serves as in vitro potency test for biological activity as part of product profile.•Assay discriminates responses to intact and heat treated material.•Assay response reflects immunostimulatory effects of adjuvant. Potency assays for vaccine products are an important regulatory requirement, and are used to assess product quality and consistency prior to lot release for clinical testing. Ideally they measure an established correlate of efficacy or protection. In cases where there is no known correlate of protection, however, a functional assay that measures a biological response to a vaccine can be applied as a potency assay. Here we describe an in vitro assay which quantitatively measures human T cell activation as a biological response to the TB vaccine candidate H4-IC31. The Cytokine Secretion Assay (CSA) is based on the ability of peripheral blood mononuclear cells (PBMCs) from a Bacillus Calmette-Guérin (BCG)-vaccinated human donor to process and respond to H4-IC31. The ability of H4-IC31 to stimulate a cellular immune response is measured through the quantification of secreted IFNγ and is reported as relative stimulatory activity (RSA) compared to an in-house reference standard. The CSA is specific to the H4-IC31 vaccine, determines the RSA of H4-IC31 in the range of 50% to 150% of the reference standard, and is stability indicating as it detects differences in RSA between intact and heat treated H4-IC31. Although the CSA does not provide a link to clinical efficacy, it fulfills the critical requirements for a biological potency test to assess TB vaccine candidates and can be used along with biochemical and immunochemical assays to define a product profile during clinical development, while eliminating the use of animals for product testing.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0264-410X
fulltext: fulltext
issn:
  • 0264-410X
  • 1873-2518
url: Link


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titleAn in vitro functional assay to measure the biological activity of TB vaccine candidate H4-IC31
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creatorMing, Marin ; Bernardo, Lidice ; Williams, Kimberley ; Kolattukudy, Pappachan ; Kapoor, Nidhi ; Chan, Leslie G ; Pagnon, Anke ; Piras, Fabienne ; Su, Jin ; Gajewska, Beata ; Salha, Danielle ; Gisonni-Lex, Lucy
creatorcontribMing, Marin ; Bernardo, Lidice ; Williams, Kimberley ; Kolattukudy, Pappachan ; Kapoor, Nidhi ; Chan, Leslie G ; Pagnon, Anke ; Piras, Fabienne ; Su, Jin ; Gajewska, Beata ; Salha, Danielle ; Gisonni-Lex, Lucy
description•In vitro assay measures biological activity of vaccine in human PBMC.•H4-IC31 stimulates PBMC IFNγ secretion in cells from BCG-immunized individual.•Assay serves as in vitro potency test for biological activity as part of product profile.•Assay discriminates responses to intact and heat treated material.•Assay response reflects immunostimulatory effects of adjuvant. Potency assays for vaccine products are an important regulatory requirement, and are used to assess product quality and consistency prior to lot release for clinical testing. Ideally they measure an established correlate of efficacy or protection. In cases where there is no known correlate of protection, however, a functional assay that measures a biological response to a vaccine can be applied as a potency assay. Here we describe an in vitro assay which quantitatively measures human T cell activation as a biological response to the TB vaccine candidate H4-IC31. The Cytokine Secretion Assay (CSA) is based on the ability of peripheral blood mononuclear cells (PBMCs) from a Bacillus Calmette-Guérin (BCG)-vaccinated human donor to process and respond to H4-IC31. The ability of H4-IC31 to stimulate a cellular immune response is measured through the quantification of secreted IFNγ and is reported as relative stimulatory activity (RSA) compared to an in-house reference standard. The CSA is specific to the H4-IC31 vaccine, determines the RSA of H4-IC31 in the range of 50% to 150% of the reference standard, and is stability indicating as it detects differences in RSA between intact and heat treated H4-IC31. Although the CSA does not provide a link to clinical efficacy, it fulfills the critical requirements for a biological potency test to assess TB vaccine candidates and can be used along with biochemical and immunochemical assays to define a product profile during clinical development, while eliminating the use of animals for product testing.
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subjectAssaying ; Bacillus Calmette-Guerin vaccine ; BCG ; BCG vaccines ; Biological activity ; Blood & organ donations ; Cell activation ; Cell based potency ; Cellular immune response ; Clinical trials ; Correlation analysis ; Cytokines ; Heat treatment ; Immune response ; Immune system ; In vitro potency ; Infections ; Laboratory animals ; Leukocytes (mononuclear) ; Lymphocytes ; Lymphocytes T ; Manufacturers ; Manufacturing ; Medical research ; Medicine, Experimental ; Mycobacterium tuberculosis ; Peptides ; Peripheral blood mononuclear cells ; Proteins ; Quality assessment ; Quality control ; T cells ; Tuberculosis ; Tuberculosis vaccine ; Tuberculosis vaccines ; Vaccination ; Vaccine evaluation ; Vaccines ; γ-Interferon
ispartofVaccine, 2019-05-16, Vol.37 (22), p.2960-2966
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description•In vitro assay measures biological activity of vaccine in human PBMC.•H4-IC31 stimulates PBMC IFNγ secretion in cells from BCG-immunized individual.•Assay serves as in vitro potency test for biological activity as part of product profile.•Assay discriminates responses to intact and heat treated material.•Assay response reflects immunostimulatory effects of adjuvant. Potency assays for vaccine products are an important regulatory requirement, and are used to assess product quality and consistency prior to lot release for clinical testing. Ideally they measure an established correlate of efficacy or protection. In cases where there is no known correlate of protection, however, a functional assay that measures a biological response to a vaccine can be applied as a potency assay. Here we describe an in vitro assay which quantitatively measures human T cell activation as a biological response to the TB vaccine candidate H4-IC31. The Cytokine Secretion Assay (CSA) is based on the ability of peripheral blood mononuclear cells (PBMCs) from a Bacillus Calmette-Guérin (BCG)-vaccinated human donor to process and respond to H4-IC31. The ability of H4-IC31 to stimulate a cellular immune response is measured through the quantification of secreted IFNγ and is reported as relative stimulatory activity (RSA) compared to an in-house reference standard. The CSA is specific to the H4-IC31 vaccine, determines the RSA of H4-IC31 in the range of 50% to 150% of the reference standard, and is stability indicating as it detects differences in RSA between intact and heat treated H4-IC31. Although the CSA does not provide a link to clinical efficacy, it fulfills the critical requirements for a biological potency test to assess TB vaccine candidates and can be used along with biochemical and immunochemical assays to define a product profile during clinical development, while eliminating the use of animals for product testing.
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titleAn in vitro functional assay to measure the biological activity of TB vaccine candidate H4-IC31
authorMing, Marin ; Bernardo, Lidice ; Williams, Kimberley ; Kolattukudy, Pappachan ; Kapoor, Nidhi ; Chan, Leslie G ; Pagnon, Anke ; Piras, Fabienne ; Su, Jin ; Gajewska, Beata ; Salha, Danielle ; Gisonni-Lex, Lucy
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abstract•In vitro assay measures biological activity of vaccine in human PBMC.•H4-IC31 stimulates PBMC IFNγ secretion in cells from BCG-immunized individual.•Assay serves as in vitro potency test for biological activity as part of product profile.•Assay discriminates responses to intact and heat treated material.•Assay response reflects immunostimulatory effects of adjuvant. Potency assays for vaccine products are an important regulatory requirement, and are used to assess product quality and consistency prior to lot release for clinical testing. Ideally they measure an established correlate of efficacy or protection. In cases where there is no known correlate of protection, however, a functional assay that measures a biological response to a vaccine can be applied as a potency assay. Here we describe an in vitro assay which quantitatively measures human T cell activation as a biological response to the TB vaccine candidate H4-IC31. The Cytokine Secretion Assay (CSA) is based on the ability of peripheral blood mononuclear cells (PBMCs) from a Bacillus Calmette-Guérin (BCG)-vaccinated human donor to process and respond to H4-IC31. The ability of H4-IC31 to stimulate a cellular immune response is measured through the quantification of secreted IFNγ and is reported as relative stimulatory activity (RSA) compared to an in-house reference standard. The CSA is specific to the H4-IC31 vaccine, determines the RSA of H4-IC31 in the range of 50% to 150% of the reference standard, and is stability indicating as it detects differences in RSA between intact and heat treated H4-IC31. Although the CSA does not provide a link to clinical efficacy, it fulfills the critical requirements for a biological potency test to assess TB vaccine candidates and can be used along with biochemical and immunochemical assays to define a product profile during clinical development, while eliminating the use of animals for product testing.
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