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Commissioned Research Support for Vaccine Development Principle Investigator Name Title Tel.: Mobile: Fax: E-mail: Name of Organization Mailing Address Country: Research Project Project Title Project Acronym (max 20 characters) Project Summary Total Budget Requested In most cases, initial discussions will need to occur with service provider to estimate budget request Requested Access to Service (Please check) Please be aware that all research support offered here must be applied for specifically as needed in the context of vaccine development. For specific questions regarding the individual services, please contact the providers directly Adjuvants Three independent adjuvants: sodium arsenite, gramacidine and dithiocarbonate and high throughput template to analyse sequentially molecular interactions between any other adjuvant and dendritic T and B cells with particular reference to the inflammasome and homeostatic pathways leading to immunological memory. Cost €39,000 (+overheads) . King’s College of London, T. Lehner ([email protected]). Animal models Mouse Model: Perform pre-clinical studies in the mouse model to assess the immunogenicity of vaccine formulations and prime-boost strategies. Studies will include the analysis of humoral and cellular responses. 7.200€ / vaccine group (of 6 mice), max 6 groups per study. University of Siena, D Medaglini ([email protected]) Chlamydia Challenge Mouse Model: Perform immunogenicity analysis and challenge experiment in the Chlamydia mouse model. Immunogenicity + Challenge of a group of 12 mice. The prize includes control groups (negative / positive). 12.000€ / vaccine group (of 10 mice) up to 4 groups Statens Serum Institut, Frank Follmann ([email protected]) TB Challenge Mouse Model: Perform immunogenicity analysis and challenge experiment in the TB mouse model. Immunogenicity + Challenge of a group of 10 mice. The prize includes control groups (negative / positive). 10.000€ / vaccine group (of 10 mice), up to 4 goups, Statens Serum Institut, Else Marie Agger ([email protected]) Influenza Challenge Mouse Model: Perform influenza challenge models following immunisation. Immunisation can be by various routes, both mucosal and systemic. Infection can be with H1N1, H3N2 or B strains, enabling homologous or heterologous infection and protection assessed by disease and viral load measurements. Assess immunogenicity in the same animals – both antibody and cellular. N=5 mice per group, max 6 groups per study. Cost TBD. Imperial College London, J Tregoning ([email protected]) Animal model to assess vaccination induced cellular immune responses and immune modulation: Perform pre-clinical studies to test vaccination induced cellular responses and immunomodulatory activity of peptides and proteins, delivered via the intradermal route. Groups of 10 animals with full cellular immunological monitoring following dermal vaccination. 8000€ per group, University Utrecht, Willem van Eden ([email protected]) Human Trials Support from concept through to completion Human Challenge Models for Typhoid and parathyphoid vaccination/infection Cost TBD. University of Oxford, A. Pollard ([email protected]). Human Trials support from concept through to completion (including infants) for systems immunology to study transcriptome, B/T cell immunology. Cost TBD. University of Oxford, A. Pollard ([email protected]). Clinical trial support from concept through to completion. Services can include: protocol design and review, regulatory submissions and approvals, sponsorship of clinical trials, project management of trial, pharmacovigilance and monitoring support, clinical trial delivery ,laboratory processing of samples, data management, statistical analysis and clinical study reporting. Cost TBD. Surrey Clinical Research Centre, D. Lewis ([email protected]) MLPA Assay Reverse Transcription Multiplex Ligation-dependent Probe Amplification is high throughput assay, which can rapidly profile mRNA expression of host. €25 per sample. Leiden University Medical Center, T.Ottenhoff ([email protected]) Multiplex detection of cytokine and chemokine biomarkers: evaluate the production of cell signaling proteins, such as cytokines, chemokines, and inflammatory biomarkers in multiple samples, using the Bio-Plex suspension array system. Cost/sample €125,00 University of Siena, A Ciabattini ([email protected]) Formulation of vaccine antigens onto biodegradable particles: Formulate sub-unit or vaccine components onto biodegradable particles, containing or not in their core, different immune-modulators, such as TLR or Nod ligands, by using passive adsorption process onto Poly Lactic Acid (PLA) particles of 150<x<200nm size. 5/6 per year. €30Ke/unit CNRS, B Verrier. ([email protected]) Toxicity studies of vaccine components (adjuvant, antigens): determines the acute or letal toxicity of chemicals on embryonic stages of fish. Newly fertilized zebrafish eggs are exposed to the selected chemical for a period of 96 hours including different increasing concentrations of the chemical tested and a control. Every 24 hours, several apical observations are recorded as indicators of lethality: (i) coagulation of fertilized eggs, (ii) lack of somite formation, (iii) lack of detachment of the tail-bud from the yolk sac, and (iv) lack of heartbeat V) mobility. At the end of the exposure period, acute toxicity is determined based on a positive outcome in any of the four apical observations recorded, and the LC50 is calculated. Cost 10 /unit, €10ke Systems biology analysis and mathematical modeling: Construction, simulation and identification of stochastic and deterministic dynamical mathematical models of adaptive immune response in animal models. Statistical analysis of experimental data (probability distribution function estimation, classification, etc.). Interference of gene regulation networks. COst €15000,00 Euro/unit, where the unit is PM. Università di Siena – Dipartimento di Ingegneria dell’Informazione e Scienze Matematiche, A Vicino ([email protected]) Description of laboratory Please describe your laboratory and its associated facilities in relation to this request Relevant Publications Please list here your publications (with d.o.i) relevant to your application -maximum 5 – 1. 2. 3. 4. 5. ADITEC Project Sclavo Vaccines Association Siena - Italy Email: [email protected] http://www.aditecproject.eu/home.html