Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.4.2-1 | Award Amount: 7.88M | Year: 2014
Vancomycin is the critically important antibiotic to treat neonatal Late Onset Sepsis (LOS) due to Gram positive bacteria in neonates, including Coagulase Negative Staphylococci (CoNS) and Staphylococcus aureus. These organisms also create biofilms which are extremely resistant to antibiotics. The increased incidence of LOS due to bacteria such as CoNS and MRSA in NICUs has led to a marked increased use of vancomycin, which is now the third commonest antibiotic used in European NICUs. However, a standardised dosing regimen for premature infants has not yet been defined and there is no data about the serum concentrations needed to ensure bacterial kill for CoNS in humans. In view of the lack of any firm dosage for neonates and infants, vancomycin has been included in the EMA list of off-patent drugs addressing unmet therapeutic needs in children. Accordingly NeoVanc consortium has already submitted a Paediatric Investigation Plan (PIP) which has provisionally received a favourable 120 day opinion and this application is built on what is included in the approved PIP. This project aims to:-develop a new age-appropriate formulation of vancomycin; define the circulating concentration of vancomycin that is needed to kill CoNS in in vitro biofilm and animal model, and use that data to derive the concentration and best PD target that will be maximally effective in neonates; define the neonatal dosage that is needed to attain the concentration that can kill CoNS and enterococci by conducting a systematic meta-analysis of all available PK data and develop an optimal dosing and therapeutic drug monitoring regimen. NeoVanc will then conduct a Phase 2 b randomised clinical trial to compare the proportion of neonates reaching the PD target derived from the pre-clinical studies when treated with the current standard vs new optimised treatment regimens and to obtain data on dosing, efficacy and short and long-term safety to be included in the SPCs leading to a PUMA.
Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: HEALTH.2011.1.4-4 | Award Amount: 40.88M | Year: 2011
Vaccines so far have been developed mostly by following an empiric approach. To prevent and possibly cure unresolved and emerging infectious diseases we need to fully exploit the potential of the human immune system. Progress in science and technology makes it possible to achieve what was previously deemed impossible. The scope of this project is to produce knowledge necessary to develop novel and powerful immunization technologies for the next generation of human vaccines. This goal requires a multidisciplinary approach in which diverse but complementary scientific disciplines and technologies converge. Therefore some of the most competitive European research groups from public institutions and biotechs have agreed to join forces in ADITEC, together with top US groups on systems biology and adjuvants to support this enterprise. A systems biology approach will be used to study licensed and experimental vaccines in patient characterization studies and in clinical trials, to investigate the effect of adjuvants, vectors, formulations, delivery devices, routes of immunization, homologous and heterologous primeboost schedules, as well as the impact of host factors such as age, gender, genetics and pathologies. Animal models will be used to complement human studies, and to select novel immunization technologies to be advanced to the clinic. To address these issues in a coordinated manner, ADITEC is organised on a matrix structure in which research themes and experimental approaches feed into each other. Training curricula will be created to impact on the formation of the next generation of EU researchers in the field. ADITEC scientists and institutions are part of the Sclavo Vaccines Association (SVA), which is dedicated to vaccines and vaccine research. SVA, acting as the coordinating institution, guarantees the long-term commitment and sustainability of this initiative, beyond the duration of ADITEC itself.
Agency: Cordis | Branch: H2020 | Program: ERC-ADG | Phase: ERC-ADG-2014 | Award Amount: 2.35M | Year: 2016
Fifteen years ago it was widely believed that asthma was an allergic/atopic disease caused by allergen exposure in infancy; this produced atopic sensitization and continued exposure resulted in eosinophilic airways inflammation, bronchial hyper-responsiveness and reversible airflow obstruction. It is now clear that this model is at best incomplete. Less than one-half of asthma cases involve allergic (atopic) mechanisms, and most asthma in low-and-middle income countries is non-atopic. Westernization may be contributing to the global increases in asthma prevalence, but this process appears to involve changes in asthma susceptibility rather than increased exposure to established asthma risk factors. Understanding why these changes are occurring is essential in order to halt the growing global asthma epidemic.This will require a combination of epidemiological, clinical and basic science studies in a variety of environments. A key task is to reclassify asthma phenotypes. These are important to: (i) better understand the aetiological mechanisms of asthma; (ii) identify new causes; and (iii) identify new therapeutic measures. There are major opportunities to address these issues using new techniques for sample collection from the airways (sputum induction, nasal lavage), new methods of analysis (microbiome, epigenetics), and new bioinformatics methods for integrating data from multiple sources and levels. There is an unprecedented potential to go beyond the old atopic/non-atopic categorization of phenotypes. I will therefore conduct analyses to re-examine and reclassify asthma phenotypes. The key features are the inclusion of: (i) both high and low prevalence centres from both high income countries and low-and-middle income countries; (ii) much more detailed biomarker information than has been used for previous studies of asthma phenotypes; and (iii) new bioinformatics methods for integrating data from multiple sources and levels.
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-10-2014 | Award Amount: 4.15M | Year: 2015
The PHOCNOSIS project aims at the development and the preclinical validation of a nanotechnology-based handheld point-of-care testing (POCT) analysis device for its application in the early diagnosis of cardiovascular diseases (CVD). The diagnosis will be carried out by means of the fast (<10 minutes), ultra-sensitive (<1 ng/L) and label-free detection of multiple cardiac biomarkers, using a small volume of whole blood (<100 L). This POCT analysis device will significantly help in the implementation of mass screening programs, with the consequent impact on clinical management, reducing also costs of treatments, and increasing survival rates. The PHOCNOSIS analysis device will be based on two state-of-the-art technological elements in order to obtain a compact and highly sensitive final device. First, an integrated micro-/nanofluidic system will be used for biomarkers separation, purification and concentration, targeting an effective concentration increase by a factor greater than 1000x for the targeted biomarkers. Then, the concentrated biomarkers will be detected using a novel nanophotonic-based sensing technique, envisaging a final combined detection limit below 1 ng/L. This novel sensing technique allows us to obtain systems which are low-cost, compact and with a lower complexity, thus making them suitable for the development of portable devices for POCT. The PHOCNOSIS project will target the deployment of disposable biochips with an envisaged cost below 3 to be used in a handheld analysis device with an envisaged cost below 3000. Special attention will be paid within the PHOCNOSIS project to explore the potential deployment and commercialisation of the analysis device, by means of the involvement of relevant academic and industrial partners, as well as end users.
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.3.2-2 | Award Amount: 7.87M | Year: 2013
Diabetes (DM) triples the risk of developing tuberculosis (TB). Consequently, the alarming growth of type 2 DM in TB endemic countries and among people originating from TB-endemic countries poses a serious threat to global TB control. This project addresses the scarce evidence for many of the recently advocated guidelines for care and control of TB and DM, as well as our lack of understanding of the mechanisms underlying the effect of DM on TB susceptibility and treatment outcome. We will use a comprehensive and integrated approach combining clinical, epidemiological and cutting edge expertise in laboratory sciences, bringing together a multi-disciplinary consortium linking field sites in Romania, Peru, South Africa and Indonesia, with leading laboratories in Germany, United Kingdom and the Netherlands. We will define the optimal and most cost-effective ways of screening TB patients for DM diabetes, and determine the prevalence of DM among TB patients and of TB in DM patients in the four countries. With regard to treatment, we will determine the level of DM management required during and after TB treatment, the safety and pharmacokinetics of metformin when combined with rifampicin, and the effect of hyperglycemia control on TB treatment outcome. To help establish the cellular basis and immunological pathways underlying the link between DM and TB we will provide new data on: gene expression data of TB patients with and without DM; ex vivo and in vitro Mycobacterium tuberculosis stimulation data of different cell types, including macrophage subsets and adipocytes in the presence of high glucose and insulin; data regarding the role of common and more rare genetic variants in the combined susceptibility to TB and type 2 DM; and relevant functional genomics experiments. In summary, this project is expected to have significant impact both in improving basic knowledge on the link between TB and DM, as well as on prevention, therapeutic management and prognosis of TB-DM.