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 Evaluation of potency of new exploratory adjuvants bench-marked against the established adjuvants systemically and/or mucosally as pertain to immune-profiling and functionality of the immune response in mice. University of Gothenburg, A. Harandi (ali.harandi@microbio.gu.se) 21,500€/adjuvant/1 full experiment with control and bench-mark arms. Pre-clinical QS-21 is available for use in their early vaccine formulations and GMP quality QS-21 for human clinical trials. Desert King International (ADITEC affiliated partner), D. Hiley (dfhiley@desertking.com). 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. King’s College of London, T. Lehner (thomas.lehner@kcl.ac.uk). CAF01 adjuvant for preclinical and clinical testing: 1) CAF01 is offered for free for preclinical evaluation with the limitation that an MTA has to be negotiated. And We can offer GMP quality CAF01 upon contract and price negotiation. Statens Serum Institut, Dennis Christensen (DEN@ssi.dk) Animal models Mouse Model: University of Siena, D Medaglini (Medaglini@unisi.it) Perform pre-clinical studies in the mouse model to assess the immunogenicity of vaccine formulations and prime-boost strategies. Chlamydia Challenge Mouse Model: Statens Serum Institut, Frank Follmann (FRF@ssi.dk) 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. TB Challenge Mouse Model: Statens Serum Institut, Else Marie Agger (EAG@ssi.dk) 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 Influenza Challenge Mouse Model: Imperial College London, J Tregoning (john.tregoning@imperial.ac.uk) 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. Non-Human Primate Model: CEA, Immuno-Virology & IDMIT infrastructure, R.LeGrand (roger.le-grand@cea.fr) NHP models for HIV, Flu, Chicungunya virus, Dengue, Chlamydia, Malaria Immuno-monitoring core : Flow Cytometry, Mass Cytometry (CyTof) In vivo imaging Human Trials Human Challenge Models for Typhoid and parathyphoid vaccination/infection University of Oxford, A. Pollard (andrew.pollard@paediatrics.ox.ac.uk). Human Trials (including infants) for systems immunology to study transcriptome, B/T cell immunology University of Oxford, A. Pollard (andrew.pollard@paediatrics.ox.ac.uk). 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. Surrey Clinical Research Centre, D. Lewis (D.J.Lewis@surrey.ac.uk) MLPA Assay Reverse Transcription Multiplex Ligation-dependent Probe Amplification is high throughput assay, which can rapidly profile mRNA expression of host. Leiden University Medical Center, T.Ottenhoff (T.H.M.Ottenhoff@lumc.nl) 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 University of Siena, A Ciabattini (annalisa.ciabattini@unisi.it) Formulation of vaccine antigens onto biodegradable particles: Formulate sub-unit or vaccine components onto biodegradable particles, containing or not in their core, different immunemodulators, such as TLR or Nod ligands, by using passive adsorption process onto Poly Lactic Acid (PLA) particles of 150<x<200nm size. CNRS, B Verrier. (bernard.verrier@ibcp.fr) 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. Università di Siena – Dipartimento di Ingegneria dell’Informazione e Scienze Matematiche, Antonio Vicino (vicino@ing.unisi.it) High-dimensional single cell characterization of the innate and adaptive response by CyTOF: Our laboratory established an innate and an adaptive antibody panel which are currently used to characterize immune responses in humans and NHP allowing for the deep exploration of the innate and adaptive immune response. The adaptive panel includes the detection of markers such as CD3, CD4 and CD8 to determine cell phenotype; CD45RA, CCR7, CD28 and CD95 to determine differentiation stages; IFN-γ, TNF-α, IL2, MIP-1β, CD154, CD137 to characterize T-cell function and several other markers to address the proliferative and cytotoxic capacity of the cells. The innate panel includes the detection of CD66, CD3, CD14, CD20, HLA-DR, CD11c, and CD123, to determine the cell phenotype together with antibody directed to cytokines, chemokines, TLR ligands, Fc receptors and activation markers. More than 100 different antibody clone /metal tag clones combinations were already tested and we have the capacity to establish a new antibody panel in around three months. Offer available for Public Health Organizations Only: New Vaccination Recommendations for the 50+ Generation Coordinate a study to gain knowledge about the levels of protection against vaccine-preventable diseases in different adult age groups and in different European member states and offer consultation about improved vaccination strategies. Institute for Biomedical Aging Research, Institute in Innsbruck, Beatrix Grubeck-Loebenstein. (beatrix.grubeck@uibk.ac.at) Evaluation of licensed vaccines in the elderly We offer to conduct clinical studies enrolling healthy volunteers aged 50-100 years in order to evaluate humoral and cellular immune responses against antigens of licensed vaccines. In addition to biological parameters vaccination history will be assessed in detail. Upon request we will design study protocols, conduct the clinical trial (regulatory documents, enrollment of participants, vaccination and sample collection etc.), perform laboratory analysis of humoral and cellular immune responses and data analysis. Institute for Biomedical Aging Research, Institute in Innsbruck, Beatrix Grubeck-Loebenstein. (beatrix.grubeck@uibk.ac.at) 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: info@sclavo.org http://www.aditecproject.eu/home.html