Vaccino DNA-GTU di CUT’HIVAC

Il consorzio CUT’HIVAC (gathers knowledge’s and cutting-edge technologies in vaccinology and HIV) sta sponsorizzando un altro vaccino basato su DNA-GTU dell' Hiv.
Il vaccino non si inietta ma si applica sulla cute e mucose come un gel.

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CUT’HIVAC
Cutaneous and Mucosal HIV Vaccination

Framework programme: 7
Project number: 241904
EC contribution: € 11,929,250
Duration: 60 months
Funding scheme: Large scale integrating project (IP)
Starting date: 01/01/2010

Keywords HIV vaccine, Cutaneous vaccination, Mucosal vaccination, Vaccine strategy, AIDS, needle-free vaccination, clinical trial, transcutaneous route, HIV antigen, delivery system, infectious disease, poverty-related disease
Summary

Despite significant effort over the past decade to design and implement new vaccines strategies against HIV, no one has met its promise to prevent infection and/or to reduce viral load until reaching eradication of the HIV reservoir. To reach this goal, a translational research is critical to propose innovative approaches for an HIV vaccine enhancing broadly cross-reactive mucosal, humoral and cellular immune responses specific to HIV antigens. Composed by 13 partners from 5 European countries and 2 International Cooperation countries, the CUT’HIVAC consortium gathers knowledge’s and cutting-edge technologies in vaccinology and HIV diseases to raise the challenge of developing a new HIV strategy. The CUT’HIVAC approach is based on innovative transcutaneous and/or mucosal needle-free vaccination methods in a perspective that new vaccine candidates will redirect immune response toward cytotoxic CD8 and mucosal humoral responses. The trust of the project derives from the proof-of-concept that combination of routes of immunization and delivery systems will shape the immune responses towards its protective arms against HIV. Clinical trials will be implemented with last cutting-edge generation of HIV DNA-GTU® candidate applied by transcutaneous, intradermal routes and/or mucosal administration of HIV-envelop protein-based vaccine. Large efforts will be positioned on the new genetic design of HIV antigens and delivery systems for developed and developing countries. These new vaccines will be tested in innovative preclinical approaches with a special highlight on routes of vaccination that will be translated into 2nd round of clinical trials in a perspective that could help to prevent and eradicate HIV. Through its integrative and multidisciplinary approach, CUT’HIVAC will therefore provide the basis for a novel approach in vaccination with a view to wide its application to other infectious diseases such as malaria and tuberculosis.
Problem

The Human Immunodeficience Virus (HIV)/AIDS is one of the greatest health challenges the world faces today. Despite significant efforts over the past decade to design new vaccines including inactivated-live virus, peptides, proteins or non-replicative vectors, a truly effective HIV vaccine is not yet at hand and many problems related to specific properties and the diversity of the virus as well as the definition of immune correlate or lack of appropriate small animal models remain to be overcome.Thus, the devastating consequences of HIV disease for both individuals and society make the development of safe, effective and easily administrated vaccines a critical priority in the overall plan to contain the global AIDS epidemic.
Aim

The CUT’HIVAC project aims at assessing a new HIV vaccine strategy to prevent and control HIV infection based on transcutaneous and/or mucosal needle-free vaccination. CUT’HIVAC will combine transcutaneous and/or mucosal routes and immunogen delivery systems to preferentially promote and redirect immune responses towards high level of mucosal Abs and effector CD8 cell responses directed against various HIV antigens. Taking advantage of new genetic and immunological informations provided by scientific, industrial and academic partners, CUT’HIVAC will design, develop and validate innovative immunogens and delivery systems as well as immunization methods. Both clinical trials and preclinical models of immunogenicity of HIV vaccine candidates by transcutaneous and mucosal routes will be implemented. It also aims at rapidly translating preclinical approaches into prophylactic and therapeutic clinical trials in developed and developing countries.
Expected results

The CUT’HIVAC project will shed light on understanding mechanisms of vaccine’s penetration in skin and mucosa and will highlight their impact on the quality of immune responses. Based on strong scientific knowledge of HIV disease and new technical approaches in the field of vaccinology, CUT’HIVAC will redesign efficient vaccine candidates and use innovative routes (transcutaneous and mucosal) in clinical trials on healthy volunteers and HIV-infected individuals, which will provide the basis for the introduction of entirely novel vaccination systems into the clinic. It is also obvious that these new needle-free approaches in vaccination and targeting of specific arms of the immunity could be widely applied to other infectious diseases such as malaria and tuberculosis.
Potential applications
Transcutaneous needle-free vaccination in human, and new delivery routes for worldwide vaccination
Development of vaccine for other infectious and poverty-related diseases such as malaria and tuberculosis
Accelerating the development of new HIV vaccine for therapeutic, preventive and cost effective medical treatments
Reduction of animal testing thanks to new knowledge gained on human explants


Coordinator

Dr. Behazine COMBADIERE, PhD
Research Director, DR2 INSERM

Institution address
Team “Vaccination and Immune Memory”
INSERM U945 – 91 Boulevard de l’Hôpital
75013 PARIS
FRANCE
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Partners
No
Principal Scientific Participants
Official Address Other Information

1
Université Pierre et Marie Curie (FR)
Université Pierre et Marie Curie Team “Vaccination and Immune Memory”, INSERM U945 91 Boulevard de l’hôpital F-75013 Paris, France Email: B. Combadière [Devi essere iscritto e connesso per vedere questo link]

2 University of Regensburg (DE) University of Regensburg Molecular Microbiology & Gene Therapy Unit - Institute of Medical Microbiology and Hygiene Franz-Josef-Strauss-Allee 11 D-93053 Regensburg, Germany Email: R. Wagner
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3
IRSICAIXA Foundation (SP)
IRSICAIXA Foundation Laboratori de Retrovirologia, Fundació irsiCaixa, Hospital Universitari Germans Trias i Pujol Ctra del Canyet s/n 08916 Badalona Barcelona Cataloni, Spain Email: C. Brander
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4
FIT Biotech Oy Ltd (FI)
FIT Biotech Oy Ltd Biokatu 8 33520 Tamper Finland Email: I. Stanescu [Devi essere iscritto e connesso per vedere questo link]

5
CHARITE (DE)
CHARITE Universitätsmedizin Berlin Clinical Research Center for Hair and Skin Science Department of Dermatology and Allergy Charité, Charitéplatz 1 10117 Berlin, Germany Email: U. Blume-Peytavi
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6
Saint George’s University of London (UK)
Saint George’s University of London Departement of cellular and molecular Medicine – Department of Infectious Disease Cranmer Terrace London SW17 0RE UK Email: R. Shattock
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7
nvestigaciones Medicas En Salud (PE)
Investigaciones Medicas En Salud Jr. José de la Torre Ugarte 166, Lince L 14, LIMA Peru Email: J. Sanchez
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8
Centre National de la Recherche Scientifique (FR)
Centre National de la Recherche Scientifique Institut de Biologie et Chimie des Protéines, UMR 5086 CNRS/UCBL, 7 Passage du Vercors, 69367 LYON Cedex 07, France
Email: B. Verrier
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9
Medical Research Council (UK)
Medical Research Council MRC Clinical Trials Unit 222 Euston Road London NW1 2DA UK
Email: S. McCormack [Devi essere iscritto e connesso per vedere questo link]

10
Institut National de la Santé et de la Recherche Médicale (FR)
Institut National de la Santé et de la Recherche Médicale Hôpital Pitié-Salpêtrière Service Maladies Infectieuses et Tropicales 47/83 Boulevard de L'Hôpital 75651 Paris Cedex 13
Email: D. Costagliola [Devi essere iscritto e connesso per vedere questo link]

11
Instituto Nacional de Saúde (MO)
Instituto Nacional de Saúde Recinto do HCM P.O.Box 264 Maputo Mozambique
Email: I. Jani
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12
P2R S.A.S (FR)
P2R S.A.S Projets et Réseaux de Recherche 69, rue de la République 69002 Lyon, France
Email: M-L. Muiras
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13
GENEART AG (DE)
GENEART AG Im Gewerbepark B35 D-93059 Regensburg Germany
Email: F. Notka [Devi essere iscritto e connesso per vedere questo link]


Source: European Commission - Research - Health - Infectious Diseases - FP7 projects