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Clinical development of a Pfs48/45-based malaria transmission blocking vaccine

Objective

Malaria vaccines are needed to reduce the unacceptably high burden of disease and death in particular in the lowest income countries. Malaria vaccines aim at interruption of the life cycle of the parasite Plasmodium falciparum by induced immune responses in the humans. Transmission-blocking vaccines (TBMV) specifically aim at an arrest sexual stage development preventing the generation of infectious mosquitoes. TBMVs are the most effective tools for reduction of the spread of malaria in the population. This is indispensible for sustained control, elimination and eventually eradication. Pfs48/45 is the most advanced EU-developed malaria TBMV candidate. PF10C is a subunit of Pfs48/45 that has been produced as R0-PF10C in a 20L fermentor. Immunization with 100% properly folded R0-PF10C induced transmission-blocking activity in 100% of immunized mice.

Objectives: 1) Manufacture R0-PF10C at cGMP grade and 2) Prepare for clinical trials with R0-PF10C in Africa.

Workplan: R0-PF10C production will be optimized and up-scaled for release of clinical grade batches for human trials. To prepare for clinical testing to Africa, preparation for Phase II will be initiated. A Phase II trial of a malaria TB vaccine will require a specific design. Important transmission parameters will be collected and introduced in a mathematical model to study the possible impact on transmission in the selected study area.
Milestones: 1) Batch release R0-PF10C for use in clinical trial; 2) Preparation of field site for phase IIb clinical trial with R0-PF10C vaccine

Call for proposal

FP7-HEALTH-2009-single-stage
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Coordinator

STICHTING RADBOUD UNIVERSITEIT
Address
Houtlaan 4
6525 XZ Nijmegen
Netherlands

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Annemieke Jansens (Dr.)
EU contribution
€ 1 151 400,30

Participants (5)

STATENS SERUM INSTITUT
Denmark
EU contribution
€ 357 600
Address
Artillerivej 5
2300 Kobenhavn S

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Activity type
Research Organisations
Administrative Contact
Michael Scheel Theisen (Dr.)
LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER
United Kingdom
EU contribution
€ 312 424,80
Address
Keppel Street
WC1E 7HT London

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jana Sabinovska (Ms.)
GENNOVA BIOPHARMACEUTICALS LIMITED
India
EU contribution
€ 1 026 469
Address
Emcure House T 184 Midc Bhosari
411026 Pune

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Santoshree Dasgupta (Ms.)
THE GOOD SAMARITAN FOUNDATION (KILIMANJARO CHRISTIAN MEDICAL CENTRE GSF KCMC)
Tanzania
EU contribution
€ 37 500
Address
Kilimanjaro Christian Medical Centre
- Moshi

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Activity type
Other
Administrative Contact
Gibson Kibiki (Prof.)
AFRICAN MALARIA NETWORK TRUST

Participation ended

Tanzania
EU contribution
€ 114 603,90
Address
Ring Street Off Rose Garden Road 302
33207 Dar Es Salaam

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Activity type
Research Organisations
Administrative Contact
Ramadhani Abdallah Noor (Dr.)