REDMAL
Clinical development of a Pfs48/45-based malaria transmission blocking vaccine
| Coordinatore | STICHTING KATHOLIEKE UNIVERSITEIT
Organization address
address: GEERT GROOTEPLEIN NOORD 9 contact info |
| Nazionalità Coordinatore | Netherlands [NL] |
| Totale costo | 4˙579˙673 € |
| EC contributo | 2˙999˙998 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2009-single-stage |
| Funding Scheme | CP-FP |
| Anno di inizio | 2010 |
| Periodo (anno-mese-giorno) | 2010-03-01 - 2014-11-30 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
STICHTING KATHOLIEKE UNIVERSITEIT
Organization address
address: GEERT GROOTEPLEIN NOORD 9 contact info |
NL (NIJMEGEN) | coordinator | 1˙151˙400.20 |
| 2 |
GENNOVA BIOPHARMACEUTICALS LIMITED
Organization address
address: EMCURE HOUSE T 184 MIDC BHOSARI contact info |
IN (PUNE) | participant | 1˙026˙469.00 |
| 3 |
STATENS SERUM INSTITUT
Organization address
address: ARTILLERIVEJ 5 contact info |
DK (KOBENHAVN S) | participant | 357˙600.00 |
| 4 |
LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE
Organization address
address: KEPPEL STREET contact info |
UK (LONDON) | participant | 312˙424.80 |
| 5 |
AFRICAN MALARIA NETWORK TRUST
Organization address
address: RING STREET OFF ROSE GARDEN ROAD 302 contact info |
TZ (DAR ES SALAAM) | participant | 114˙603.90 |
| 6 |
THE GOOD SAMARITAN FOUNDATION (KILIMANJARO CHRISTIAN MEDICAL CENTRE GSF KCMC)
Organization address
address: KILIMANJARO CHRISTIAN MEDICAL CENTRE contact info |
TZ (MOSHI) | participant | 37˙500.00 |
Mappa
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Obiettivo del progetto (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'