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The iHIVARNA strategy proposes using an mRNA-based therapeutic vaccine encoding HIV antigens as a novel and promising approach in HIV immunotherapy.

The four-year 6M€ European project iHIVARNA, funded by the European Commission, aims to successfully immunize antiretroviral-treated HIV-infected patients with 3 injections of the candidate universal HIV-TriMix-mRNA as an mRNA-based therapeutic vaccine with the final aim of improving the efficacy of therapeutic vaccination against HIV infection.

iHIVARNA is addressing the topic “Safety and efficacy of therapeutic vaccines” of the European Commission 7th Framework Programme Health 2013. The project brings together the expertise of a number of European groups (Spain, Belgium, and Netherlands) in dendritic cell targeting, rational design of immunogens, mRNA manufacturing and immuno-virological monitoring. This proposal continues the work in therapeutic vaccines performed in the last few years in the AIDS Research Unit of Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) leaded by Dr. Josep M Gatell and IrsiCaixa.

 

Our novel therapeutic vaccine candidate is going to be tested for the first time in two phase I and phase IIa clinical trials to assess if it is a valid alternative to lifelong cART treatment.

Dr. Felipe García, IDIBAPS

Dr. Josep M Gatell said: “Nowadays, over 30 million people worldwide are infected with HIV, most of them living in developing countries. Although combined antiretroviral therapy (cART) has proven to be highly effective to prevent clinical progression and death, by itself it is unable to eradicate the infection and other alternative approaches are urgently needed”. The consortium coordinator Dr. Felipe García, from IDIBAPS said: “Therapeutic vaccinations – vaccines targeting HIV infected patients with the ultimate aim of achieving a functional cure – have emerged as one of the most promising strategies that could restore HIV-specific T-cell responses in HIV infected patients and help them control viral replication without cART. Our novel therapeutic vaccine candidate is going to be tested for the first time in two phase I and phase IIa clinical trials to assess if it is a valid alternative to lifelong cART treatment.”

iHIVARNA-vaccine-candidate

 

The iHIVARNA vaccine candidate is the result of a long lasting scientific track record of the Consortium. The candidate is based on an innovative approach that uses naked mRNA, so far has only been recently applied in the cancer research field.  The HIV-TriMix-mRNA has two parts: HIV that has been rationally designed by IrsiCaixa based on data from large international cohorts; and TriMix designed by Vrije Universiteit Brussel to activate and target dendritic cells to improve the HIV antigen presentation. The combination of mRNA, rationally designed HIV antigen and TriMix is a very innovative approach for a therapeutic vaccine and is expected to improve the results of other more traditional strategies already tested.

Studies included in iHIVARNA comprise 1) the manufacturing of the HIV-TriMix-mRNA in GMP conditions, 2) a phase I dose escalation clinical trial and a phase IIa-proof-of-concept clinical trial to test safety, efficacy and immunogenicity of the vaccine candidate, and 3) ascertaining immune and viral predictors and correlates of protection.

For more information visit www.ihivarna.org

 

The General Assembly meetings take place twice per year and include senior representatives from each full partner of the ADVANCE project. The 2nd General Assembly meeting took place in Sitges, Spain between 27th-28th March 2014.

During the meeting, the Partners and Associate Partners shared updates on project progress to date and discussed how to move forward both at Work Package and Consortium levels. The two-day assembly was attended by over 65 people, including representatives from 25 of the full Partners, and 10 Associate Partners.

The meeting also allowed for several workshops to take place in relation to the ADVANCE Work Packages and thus contributed to good communication and working relations within and between the Work Packages.

In order to take further advantage of the gathering of Partners and Associate Partners; film-makers from the EU initiative CommHERE were also present at the meeting, where they had the opportunity to interview some of the key members of the ADVANCE Project. The footage will be used to develop a short video which will be used for communication on the outcome of the ADVANCE project to the media, the general public and other target groups including the EC in all of Europe and beyond.

For more information visit www.advance-vaccines.eu

 

EU grants a Project to build a platform to better recruit patients for clinical trials, especially those suffering from rare diseases

Barcelona hosts the kick-off meeting of the SEMCARE Project, which addresses the ever growing need to exploit medical data from clinical trials and for monitoring and improving healthcare delivery.

The two-year 1.5M€ European Project SEMCARE, funded by the European Commission, aims to build a semantic data platform able to identify patient cohorts based on clinical criteria (e.g. age, gender, diagnosis, indication, symptoms, lab results) scattered in heterogeneous clinical resources.

Currently, almost 80% of clinical trials fail to meet their patient enrolment quotas on time, causing delays in bringing new drugs to market. Exploiting patient-level data can optimize clinical studies in several ways, including better access to patients to new drugs and treatments and allowing pharmaceutical companies to earlier complete clinical trials, thus allowing drugs to reach the market in a shorter time frame.

SEMCARE is addressing the challenge “Technologies for Digital Content and Languages” of the European Commission 7th Framework Programme Information and Communication Technologies (ICT) 2013. The Project brings together the expertise of several EU players, including hospitals from three different European countries (Netherlands, UK and Austria) serving as pilot sites and with a particular interest in applying SEMCARE in their clinical research activities.

The Project addresses the “SME initiative on analytics” objective, which is oriented to help European Small and Medium Enterprises (SMEs) acquire the competences and resources they need to develop innovative content and data analytics services.

 

A better use of patient’s data will make a difference in addressing complex research and clinical challenges. We are proud to be part of a project that focuses on helping patients with rare diseases to ultimately have better diagnosis and treatment

Carlos Díaz - CEO of SYNAPSE

 

According to Mr. Carlos Díaz CEO of SYNAPSE, the Spanish project management partner of SEMCARE: “A better use of patient’s data will make a difference in addressing complex research and clinical challenges. We are proud to be part of a project that focuses on helping patients with rare diseases to ultimately have better diagnosis and treatment”. The Project Coordinator, Dr. Philipp Daumke, CEO of AVERBIS, a German SME specialized on text analytics, search technologies and data semantics applied to the healthcare sector, said: “Our long-term objective is to build a pan-European supported platform that hospitals all over Europe can use for patient identification in clinical trials and for diagnosis support, especially in the case of rare diseases.”

SEMCARE will integrate state-of-the-art text mining technologies and multilingual semantic resources (domain vocabularies, terminologies, nomenclatures, classifications, ontologies; in the following referred to as terminologies) to address specific idiosyncrasies of medical language like ambiguous terms, acronyms, compounds, derivations, spelling variants, uncorrected spelling errors, jargon, telegram style, etc.

SYNAPSE’s role in the project is focused on providing a management structure that both helps and monitors the project development and integration, which is a crucial tool for its success. Additionally, SYNAPSE will contribute to the development of the market analysis and play an important role in defining SEMCARE’s commercial exploitation and business planning.

By the end of 2016, the Project will produce a prototype that can provide diagnostic support and allows patient identification for device therapies or clinical trials (e.g., drugs, diagnostics, devices, therapy protocols) based on patient-level records.

 

ADVANCE_currentProjectsLeading organisations have joined forces to launch a unique project that will pave the way for a pan-European framework for rapidly assessing and communicating the benefits and risks of vaccines. Such a framework would make it easier for regulators and public health authorities to make fast, more informed decisions regarding vaccination strategies, and help to maintain public confidence in immunisation, particularly when questions are raised about the safety of specific vaccines.

The five-year, €10.7 million ADVANCE (‘Accelerated development of vaccine benefit-risk collaboration in Europe’) project is supported by the Innovative Medicines Initiative (IMI) and brings together the European Centre for Disease Prevention and Control (ECDC), the European Medicines Agency (EMA), as well as vaccine manufacturers, national public health and regulatory bodies, academic experts, and small and medium-sized enterprises (SMEs). ADVANCE is co-coordinated by the Erasmus University Medical Center in the Netherlands, the University of Basel / University Children’s Hospital Basel in Switzerland, GSK Vaccines (coordinating the vaccine manufacturers in the project) in Belgium, and Synapse Research Management Partners (Project Management) in Spain.


ADVANCE project (IMI website)

ADVANCE Press Release

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