In this newsletter we will give you an update on the recent progress we have achieved in the development and characterisation of assays aimed at detecting NA-specific antibody responses for evaluating influenza vaccines immunogenicity.
We take advantage of this end-of-the-year newsletter to wish all of you a Merry Christmas and a Happy New Year.
Progress regarding assays to detect NA-specific antibody responses for evaluating influenza vaccines immunogenicity
The contribution of anti-NA responses to the immunogenicity of influenza vaccines has recently gained increased attention amongst manufacturers, researchers and regulators. Objective of this part of the FLUCOP work programme is to advance the understanding and application of NA-Antibody titration assays as tools for evaluating influenza vaccine performance.
The work has now focused on the Enzyme-Linked-Lectin-Assay (ELLA). A comprehensive compilation of all ELLA variable parameters has been established. The data generated during preliminary work has enabled the work package to define a common protocol and narrow the list of variable parameters to focus on.
The teams involved in this work progressed into the validation process where the performances of the consensus SOP have been evaluated by different laboratories using specifically designed experiments. The work started with studies aimed at evaluation of the precision and linearity of the consensus protocol. The subsequent step in the validation exercise was the evaluation of assay robustness. As conclusion, the work progress and the statistical analysis highlighted the good performance of the consensus protocol.
The leadership of this part of the work programme is not only executed at Paul-Ehrlich-Institute but also at GSK. As industrial partner GSK´s expertise in assay validation is highly valuable to develop, optimize, standardize and validate the ELLA assay.
Other involved partners are:
Public Health England, Universitetet i Bergen, University of Siena, National Institute for Biological Standards and Control, Sanofi Pasteur, Abbott Biologicals BV, Seqirus, GSK.
Inside FLUCOP: University of Bergen
The University of Bergen (UiB) is a modern, medium sized university with 16,500 students and 3,600 faculty and staff. UiB is an internationally recognised, research intensive institution and is currently the most cited university in Norway. A wide range of traditional disciplines are taught across seven faculties, spanning 54 specialised departments; multi-disciplinary research centres and institutes. UiB is engaged in the European Union’s Framework programmes for research and technological development and has been designated as a European Research Infrastructure and a Research Training Site in several scientific fields. The Influenza Centre is based at the Department for Clinical Science at the Faculty of Medicine. The Department conducts high quality medical research, teaching and training in a wide variety of paraclinical and clinical research areas including immunology, microbiology, genetics, haematology, respiration, oncology, endocrinology, medical biochemistry and pharmacology. Strong ties with Haukeland University Hospital influence the department’s strategies, which include focused translational research to generate new knowledge and advance research fields which deliver impact for patients. The Department hosts several advanced methodological platforms, including the clinical trials unit for healthy adults, flow cytometry and genomics core facility. Researchers are organised into 20 research groups, including the Influenza Centre, which is led by Prof. Rebecca Cox.
Professor Rebecca Jane Cox is Professor of Medical Virology and heads the Influenza Centre situated in a state-of-the-art laboratory building, at the University of Bergen and Haukeland University Hospital. The centre comprises 15 enthusiastic scientists and students with a vision to reduce the global burden of influenza by leading the international effort to develop new and improved influenza vaccines. Her research focuses on preclinical and clinical development of new influenza vaccines with focus on detailed characterisation of the immune response. The key competence of the Influenza Centre is human clinical trials of influenza vaccines focusing on immunology particularly B- and T-cells. The Centre specializes in preclinical (immunogenicity and protective efficacy) studies and human clinical phase 1-4 trials of new influenza vaccines under good clinical practice (GCP). Prof. Cox’s work at the Influenza Centre involves preclinical and clinical development of pandemic influenza vaccines (H1N1, H5N1, H7N1) and next generation influenza vaccines, as well as the evaluation of currently licensed vaccines to increase our understanding of immunological mechanisms of protection.
Picture below: Team of Prof. Cox at UiB
FLUCOP publications and conference contributions
Development of an Enzyme-Linked-Lectin-Assay to measure influenza A virus neuraminidase specific antibodies.
Sediri-Schön H., Bernard M.C., Commandeur S., Strauß L., Ho S., Waldock J., Hoschler K., Engelhardt O. andWagner, R.
International Society for Influenza and other Respiratory Diseases
Meeting on Immunological Assays and Correlates of Protection for Next Generation Influenza Vaccines
The FLUCOP project is supported by the Innovative Medicines Initiative Joint Undertaking under grant agreement 115672, resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP/2007-2013) and EFPIA companies’ in kind contribution. You can contact us at: http://www.flucop.eu/contact/