Statens Serum Institute | Date: 2015-04-09
The present invention is directed to a fusion protein, antigen cocktails and immunological compositions such as vaccines against infections caused by virulent mycobacteria, e.g. by Mycobacterium tuberculosis, Mycobacterium africanum, Mycobacterium bovis, Mycobacterium microti, Mycobacterium canettii, Mycobacterium pinnipedii or Mycobacterium mungi. The fusion protein, antigen cocktails and immunological compositions are based on proteins secreted by the ESAT-6 secretion system 1 (ESX-1) and are among the most immunodominant M. tuberculosis (MTB) antigens.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-08-2014 | Award Amount: 25.06M | Year: 2015
The TBVAC2020 proposal builds on the highly successful and long-standing collaborations in subsequent EC-FP5-, FP6- and FP7-funded TB vaccine and biomarker projects, but also brings in a large number of new key partners from excellent laboratories from Europe, USA, Asia, Africa and Australia, many of which are global leaders in the TB field. This was initiated by launching an open call for Expressions of Interest (EoI) prior to this application and to which interested parties could respond. In total, 115 EoIs were received and ranked by the TBVI Steering Committee using proposed H2020 evaluation criteria. This led to the prioritisation of 52 R&D approaches included in this proposal. TBVAC2020 aims to innovate and diversify the current TB vaccine and biomarker pipeline while at the same time applying portfolio management using gating and priority setting criteria to select as early as possible the most promising TB vaccine candidates, and accelerate their development. TBVAC2020 proposes to achieve this by combining creative bottom-up approaches for vaccine discovery (WP1), new preclinical models addressing clinical challenges (WP2) and identification and characterisation of correlates of protection (WP5) with a directive top-down portfolio management approach aiming to select the most promising TB vaccine candidates by their comparative evaluation using objective gating and priority setting criteria (WP6) and by supporting direct, head-to head or comparative preclinical and early clinical evaluation (WP3, WP4). This approach will both innovate and diversify the existing TB vaccine and biomarker pipeline as well as accelerate development of most promising TB vaccine candidates through early development stages. The proposed approach and involvement of many internationally leading groups in the TB vaccine and biomarker area in TBVAC2020 fully aligns with the Global TB Vaccine Partnerships (GTBVP).
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: SC1-PM-06-2016 | Award Amount: 23.70M | Year: 2017
A highly effective malaria vaccine against Plasmodium falciparum should help prevent half a million deaths from malaria each year. New vaccine technologies and antigen discovery approaches now make accelerated design and development of a highly effective multi-antigen multi-stage subunit vaccine feasible. Leading malariologists, vaccine researchers and product developers will here collaborate in an exciting programme of antigen discovery science linked to rapid clinical development of new vaccine candidates. Our approach tackles the toughest problems in malaria vaccine design: choice of the best antigens, attaining high immunogenicity, avoiding polymorphic antigens and increasing the durability of vaccine immunogenicity and efficacy. We take advantage of several recent advances in vaccinology and adopt some very new technologies: sequencing malaria peptides eluted from the HLA molecules, parasites expressing multiple transgenes, multi-antigen virus-like particles constructed with new bonding technologies, delayed release microcapsules, and liver-targeted immunisation with vaccine vectors. We enhance our chances of success by using a multi-stage multi-antigen approach, by optimising the magnitude and durability of well-characterised immune responses to key antigens, and using stringent infectious challenges and functional assays as established criteria for progression at each stage. The consortium comprises many of the foremost researchers in this field in Europe with leading groups in the USA, Australia and Africa. We link to EDCTP programmes and harmonise our timeline to fit with the recent roadmaps for malaria vaccine development. We include a major pharma partner and several excellent European biotech companies helping enhance Europes leading position in the commercial development of vaccines. This ambitious and exciting programme should have a high chance of success in tackling the major global health problem posed by malaria.
I-MOVE-plus - I-MOVE+ Integrated Monitoring of Vaccines Effects in Europe: a platform to measure and compare effectiveness and impact of influenza and pneumococcal vaccines and vaccination strategies in the elderly
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-17-2014 | Award Amount: 7.52M | Year: 2015
The I-MOVE\ Consortium includes European Union (EU) Public Health Institutes, SME and Universities. It aims at measuring and comparing the effectiveness (VE) and impact (VI) of influenza and Pneumococcal vaccines and vaccination strategies a in the elderly population in Europe. The goal is to develop a sustainable platform of primary care practices, hospitals and laboratory networks that share validated methods to evaluate post marketing vaccine performances. The objectives are to identify, pilot test, and disseminate in EU the best study designs to measure, on a real time basis, VE (direct effect) and the VI of vaccination programmes (indirect and overall effect) against laboratory confirmed cases of influenza (types/subtypes) and pneumococcal disease (serotypes), and clinical outcomes. Cost effectiveness analysis will be conducted. Results will allow to understand factors affecting specific VE, the duration of protection of influenza and pneumococcal vaccines, the interaction between vaccines, the role of repeated vaccinations, the occurrence of serotype replacement (pneumococcus); identify vaccine types and brands with low VE; guide the decision of the WHO committees on vaccine strain selection (influenza); provide robust benefit indicators (VE and VI) and cost benefit and effectiveness results; guide vaccination strategies (schedules, doses, boosters). This EU member state collaboration will respond to questions that require studies based on large sample sizes and sharing of expertise that cannot be achieved by one country alone. It will allow the best methods to be used and results to benefit to all EU countries whatever their current public health achievements. Results will be shared with international partners.
Kullberg B.J.,Radboud University Nijmegen |
Arendrup M.C.,Statens Serum Institute
New England Journal of Medicine | Year: 2015
Invasive candidiasis is the most common fungal disease among hospitalized patients in the developed world. Invasive candidiasis comprises both candidemia and deep-seated tissue candidiasis. Candidemia is generally viewed as the more common type of the disease, and it accounts for the majority of cases included in clinical trials. Deep-seated candidiasis arises from either hematogenous dissemination or direct inoculation of candida species to a sterile site, such as the peritoneal cavity (Fig. 1). Mortality among patients with invasive candidiasis is as high as 40%, even when patients receive antifungal therapy. In addition, the global shift in favor of nonalbicans candida species is troubling, as is the emerging resistance to antifungal drugs. During the past few years, new insights have substantially changed diagnostic and therapeutic strategies. Copyright © 2015 Massachusetts Medical Society. All rights reserved.
Geller F.,Statens Serum Institute
Nature Genetics | Year: 2014
Hypospadias is a common congenital condition in boys in which the urethra opens on the underside of the penis. We performed a genome-wide association study on 1,006 surgery-confirmed hypospadias cases and 5,486 controls from Denmark. After replication genotyping of an additional 1,972 cases and 1,812 controls from Denmark, the Netherlands and Sweden, 18 genomic regions showed independent association with P < 5 × 10-8. Together, these loci explain 9% of the liability to developing this condition. Several of the identified regions harbor genes with key roles in embryonic development (including HOXA4, IRX5, IRX6 and EYA1). Subsequent pathway analysis with GRAIL and DEPICT provided additional insight into possible genetic mechanisms causing hypospadias.