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Application of "Systems Vaccinology" to Evaluate Inflammation and Reactogenicity of Adjuvanted Preventative Vaccines.

Lewis DJ, Lythgoe MP - J Immunol Res (2015)

Bottom Line: Advances in "omics" technology (transcriptomics, proteomics, metabolomics, genomics/epigenomics, etc.) allied with statistical and bioinformatics tools are providing insights into basic mechanisms of vaccine and adjuvant efficacy or inflammation/reactogenicity.The identification of rare events (such as those observed with initial rotavirus vaccine or suspected autoimmune complications) will require interrogation of large data sets and population-based research before application of systems vaccinology.The Innovative Medicine Initiative funded public-private project BIOVACSAFE is an initial attempt to systematically identify biomarkers of relatively common inflammatory events after adjuvanted immunization using human, animal, and population-based models.

View Article: PubMed Central - PubMed

Affiliation: Clinical Research Centre, University of Surrey, Guildford GU2 7AX, UK.

ABSTRACT
Advances in "omics" technology (transcriptomics, proteomics, metabolomics, genomics/epigenomics, etc.) allied with statistical and bioinformatics tools are providing insights into basic mechanisms of vaccine and adjuvant efficacy or inflammation/reactogenicity. Predictive biomarkers of relatively frequent inflammatory reactogenicity may be identified in systems vaccinology studies involving tens or hundreds of participants and used to screen new vaccines and adjuvants in in vitro, ex vivo, animal, or human models. The identification of rare events (such as those observed with initial rotavirus vaccine or suspected autoimmune complications) will require interrogation of large data sets and population-based research before application of systems vaccinology. The Innovative Medicine Initiative funded public-private project BIOVACSAFE is an initial attempt to systematically identify biomarkers of relatively common inflammatory events after adjuvanted immunization using human, animal, and population-based models. Discriminatory profiles or biomarkers are being identified, which require validation in large trials involving thousands of participants before they can be generalized. Ultimately, it is to be hoped that the knowledge gained from such initiatives will provide tools to the industry, academia, and regulators to select optimal noninflammatory but immunogenic and effective vaccine adjuvant combinations, thereby shortening product development cycles and identifying unsuitable vaccine candidates that would fail in expensive late stage development or postmarketing.

No MeSH data available.


Related in: MedlinePlus

Integration of multiparametric “omics” data with clinical events from human clinical trials, together with population genetics, pediatric cohorts, and animal models in the BIOVACSAFE project.
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Related In: Results  -  Collection


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fig1: Integration of multiparametric “omics” data with clinical events from human clinical trials, together with population genetics, pediatric cohorts, and animal models in the BIOVACSAFE project.

Mentions: In 2011, the 5-year BIOVACSAFE project initiated, for the first time, a program of activities that integrate a systems biology approach with animal models and established clinical evaluation of reactogenicity after immunization or natural infection, and population-based genetics, to identify biomarkers of vaccine safety and reactogenicity (see Figure 1). The 30M€ project, coordinated by the University of Surrey, UK, and Novartis Vaccines, Italy, and funded by the Innovative Medicine Initiative, is a unique public-private partnership involving four EFPIA member pharmaceutical companies (GSK Bio, Sanofi Pasteur, Novartis Vaccines, and deCODE, AmGen) with 17 academic organizations, SMEs, and public institutions. Organized into work packages, it is the first truly systematic approach to apply systems vaccinology to vaccine and adjuvant safety rather than efficacy.


Application of "Systems Vaccinology" to Evaluate Inflammation and Reactogenicity of Adjuvanted Preventative Vaccines.

Lewis DJ, Lythgoe MP - J Immunol Res (2015)

Integration of multiparametric “omics” data with clinical events from human clinical trials, together with population genetics, pediatric cohorts, and animal models in the BIOVACSAFE project.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4562180&req=5

fig1: Integration of multiparametric “omics” data with clinical events from human clinical trials, together with population genetics, pediatric cohorts, and animal models in the BIOVACSAFE project.
Mentions: In 2011, the 5-year BIOVACSAFE project initiated, for the first time, a program of activities that integrate a systems biology approach with animal models and established clinical evaluation of reactogenicity after immunization or natural infection, and population-based genetics, to identify biomarkers of vaccine safety and reactogenicity (see Figure 1). The 30M€ project, coordinated by the University of Surrey, UK, and Novartis Vaccines, Italy, and funded by the Innovative Medicine Initiative, is a unique public-private partnership involving four EFPIA member pharmaceutical companies (GSK Bio, Sanofi Pasteur, Novartis Vaccines, and deCODE, AmGen) with 17 academic organizations, SMEs, and public institutions. Organized into work packages, it is the first truly systematic approach to apply systems vaccinology to vaccine and adjuvant safety rather than efficacy.

Bottom Line: Advances in "omics" technology (transcriptomics, proteomics, metabolomics, genomics/epigenomics, etc.) allied with statistical and bioinformatics tools are providing insights into basic mechanisms of vaccine and adjuvant efficacy or inflammation/reactogenicity.The identification of rare events (such as those observed with initial rotavirus vaccine or suspected autoimmune complications) will require interrogation of large data sets and population-based research before application of systems vaccinology.The Innovative Medicine Initiative funded public-private project BIOVACSAFE is an initial attempt to systematically identify biomarkers of relatively common inflammatory events after adjuvanted immunization using human, animal, and population-based models.

View Article: PubMed Central - PubMed

Affiliation: Clinical Research Centre, University of Surrey, Guildford GU2 7AX, UK.

ABSTRACT
Advances in "omics" technology (transcriptomics, proteomics, metabolomics, genomics/epigenomics, etc.) allied with statistical and bioinformatics tools are providing insights into basic mechanisms of vaccine and adjuvant efficacy or inflammation/reactogenicity. Predictive biomarkers of relatively frequent inflammatory reactogenicity may be identified in systems vaccinology studies involving tens or hundreds of participants and used to screen new vaccines and adjuvants in in vitro, ex vivo, animal, or human models. The identification of rare events (such as those observed with initial rotavirus vaccine or suspected autoimmune complications) will require interrogation of large data sets and population-based research before application of systems vaccinology. The Innovative Medicine Initiative funded public-private project BIOVACSAFE is an initial attempt to systematically identify biomarkers of relatively common inflammatory events after adjuvanted immunization using human, animal, and population-based models. Discriminatory profiles or biomarkers are being identified, which require validation in large trials involving thousands of participants before they can be generalized. Ultimately, it is to be hoped that the knowledge gained from such initiatives will provide tools to the industry, academia, and regulators to select optimal noninflammatory but immunogenic and effective vaccine adjuvant combinations, thereby shortening product development cycles and identifying unsuitable vaccine candidates that would fail in expensive late stage development or postmarketing.

No MeSH data available.


Related in: MedlinePlus