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PRe-clinicAl studies of a PSA-based human vaccine candidate targeting visceral, cutaneOus and mucocutaneous Leishmaniasis and Development of the associated procedures for further clinical trials

Project information

Grant agreement ID: 223341

Status

Closed project

  • Start date

    1 January 2009

  • End date

    30 June 2012

Funded under:

FP7-HEALTH

  • Overall budget:

    € 4 004 911,30

  • EU contribution

    € 2 737 149

Coordinated by:

VIRBAC SA

France

Objective

The global aim of RAPSODI is : · to develop a human vaccine candidate against most or all Leishmania species that cause the most severe leishmaniasis in the world. An unique vaccinal solution will thus be provided to protect against the various clinical phenotypes (namely visceral, cutaneous and mucocutaneaous leishmaniasis, VL, CL and ML respectively). · to establish all the associated procedures required for the subsequent clinical trials, such as the selection of the appropriate patients and assessment of vaccine efficiency. For that purpose, an international consortium constituted of countries from endemic areas (India, Peru, Tunisia, Spain and France) and embracing multi-disciplinary approaches has been set-up. Based on successful results on VL dogs, the best VL animal model to date, RAPSODI will propose a second generation human-compatible vaccine candidate and confirm its activity in pre-clinical studies. As the chosen antigen is common to most, if not all, Leishmania species, an ambitious universal immunoprotective response is being sought. RAPSODI will also address the question of population selection in order to ascertain relevant and meaningful clinical trials and vaccination campaigns. Indeed, resistant individuals, when involved in either vaccinated or placebo groups, represent important bias to the analysis of the results. RAPSODI will investigate further the parasitological, immunological and genetic features of such clinical status, and will subsequently apply the generated knowledge to the development of assays and field tests, which represent stand-alone results. The package (vaccine candidate + diagnostic/prognostic tools) proposed by RAPSODI represents a global solution, and as such is believed to have a real impact on the worldwide leishmaniasis problem.

Coordinator

VIRBAC SA

Address

Rue 13eme Lid
06511 Carros

France

Activity type

Private for-profit entities (excluding Higher or Secondary Education Establishments)

EU Contribution

€ 565 024,60

Administrative Contact

Cherifa Hemadou (Ms.)

Participants (8)

INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT

France

EU Contribution

€ 404 093

INSTITUTO DE SALUD CARLOS III

Spain

EU Contribution

€ 554 300,80

INDIAN COUNCIL OF MEDICAL RESEARCHSOCIETY

India

EU Contribution

€ 330 840

UNIVERSIDAD PERUANA CAYETANO HEREDIA

Peru

EU Contribution

€ 444 351,70

INSTITUT PASTEUR DE TUNIS

Tunisia

EU Contribution

€ 300 175,70

AYMING

France

EU Contribution

€ 90 680

INSTIMED

France

EU Contribution

€ 4 500

SYNCROSOME SAS

France

EU Contribution

€ 43 183,20

Project information

Grant agreement ID: 223341

Status

Closed project

  • Start date

    1 January 2009

  • End date

    30 June 2012

Funded under:

FP7-HEALTH

  • Overall budget:

    € 4 004 911,30

  • EU contribution

    € 2 737 149

Coordinated by:

VIRBAC SA

France