WORK PACKAGE 1  |  Coordination

LED BY

European Vaccine Initiative,

Germany

The main objective of this work package is to set up an effective management framework to ensure that PREV_PKDL progresses towards its planned objectives in line with contractual commitments. The specific objectives are to:

  • Establish an efficient management infrastructure including management bodies, independent scientific advisory and ethics committee and management procedures and tools

  • Conduct the financial and contractual management of the consortium

  • Implement day-to-day operational PREV_PKDL management

  • Ensure observance of the required ethical standards

WORK PACKAGE 2  |  

Preparation and conduct of phase II clinical trial (LEISH3) up to interim safety evaluation

LED BY

Institute of Endemic Diseases, University of Khartoum,

Sudan

The main objective of this work package is the preparation and conduct of the safety and efficacy phase II clinical trial up to an interim safety analysis on 40 recruited patients. LEISH3 is a randomised double-blind placebo controlled trial to determine whether post treatment vaccination of VL patients with ChAd63-KH protects against subsequent development of PKDL. The sponsor of the clinical trial is the University of York. The study will be conducted at the Professor El Hasssan Centre for Tropical Medicine, Dooka, Um Al Kheir and Kassab Centres, Gedaref state, Eastern Sudan. LEISH3 will be prospectively registered on ISRCTN and clinicaltrials.gov. The clinical batch that will be used for the safety cohort (first 40 subjects) was previously manufactured with funds from the Wellcome Trust (https://wellcome.ac.uk/what-we-do/teams/innovations-team) and will be kindly donated to this project.

WORK PACKAGE 3  |  GMP Production and Immunology studies of ChAd63-KH

LED BY

University of York, 

United Kingdom

The main objective of this work package are:

  • Manufacture a new clinical lot of ChAd63-KH

  • Conduct bridging immunogenicity studies in rodents

  • Prepare documentation to support use of new clinical lot in subsequent human clinical trials (including LEISH3b)

WORK PACKAGE 4  | 

LEISH3 trial continuation following DSMB and sponsor approval

LED BY

The main objective of this work package is the continuation of the LEISH3 randomised placebo controlled trial started in WP2 following the interim safety evaluation (after vaccination of first 40 patients) and a positive Go/No Go from the DSMB. Additional 260 VL patients will be recruited under WP4.

Institute of Endemic Diseases, University of Khartoum,

Sudan

WORK PACKAGE 5  |

Multidimensional, multiparameter phenotyping of VL patients

LED BY

University of Gondar, Ethiopia

The main objective of this work package is to conduct research studies in patients treated for VL from different endemic countries (Sudan, Ethiopia, Kenya and Uganda) to better understand the pathogenesis of the disease and the underlying immune mechanisms. The results of these studies, and the development of research capacity for monitoring immune responses, will help to underpin future research and product evaluation.

WORK PACKAGE 6  |  Development of flow cytometry Centre of Excellence 

LED BY

University of York,

United Kingdom

The main objective of this work package is to strengthen immunology research capacity in the LEAP countries by promoting the development of a flow cytometry network across the sites. Flow cytometry is indeed a powerful tool for interrogating immune response status, indispensable for quantifying immune responses and monitoring changes in immune status. Particularly for multicentre studies, flow cytometry brings challenges, including access to expertise, equipment support, protocol harmonisation and data management. We will therefore build a network for training and sustainable development of flow cytometry capacity in the east African region. This has both direct value for the trials described here and legacy value that will underpin future vaccine (and drug) trials for leishmaniasis and other diseases affecting these regions.

PREV_PKDL will be a vehicle to promote North-South and South-South collaboration, providing opportunities for EU early career researchers to engage with researchers in Africa. This capacity strengthening, including investment in capital and people, will help LEAP to develop as a major force for research and training on poverty-related neglected diseases in the East African Region.

WORK PACKAGE 7  |  Dissemination, exploitation and communication

LED BY

European Vaccine Initiative,

Germany

The main objectives of this work package are to:

  • Ensure appropriate, effective communication, and dissemination of project information and results

  • Foster and support exploitation of results and knowledge generated.

The main activities aiming at maximising the long-term impact of PREV_PKDL will ensure that:

  • A comprehensive plan for communication and dissemination is elaborated at the beginning of the project

  • Dissemination and exploitation activities follow a clear strategy and be closely monitored

  • Scientific outcomes is widely disseminated

  • Project results are published in high quality peer-reviewed journals providing open access as early as possible

  • Intellectual property is identified and appropriately protected

  • Exploitation potential and interests are clearly documented

  • High visibility of the project is created among relevant target groups through a set of dedicated communication activities.

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This project is part of the EDCTP2 Programme supported by the European Union (RIA2016V-1640)

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