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Malaria is one of the major infectious diseases with enormous impact on the world population. A malaria vaccine is badly needed but not yet available. The disease is caused by mosquitoes that inject small numbers of sporozoites of the Plasmodium falciparum malaria parasite into humans while taking a blood meal.
There is strong experimental evidence from animal and human studies that immunization with sporozoites administered through bites of infected mosquitoes can confer effective and long-lasting protection. The objective of this consortium is to translate this finding into a tangible vaccine product. Such objective requires 1) safety conditions to prevent malaria disease during the immunization period and 2) availability of technology to administer sporozoites by needle and syringe. The former was recently developed by partner RUNMC introducing a safe and extremely efficient protocol for complete and long lasting human protection; sporozoite inoculation by mosquitoes was combined with concomitant administration of the anti-malaria drug chloroquine. The latter has been accomplished by partner Sanaria and the capacity of stored sporozoites to infect humans by needle and syringe has been demonstrated in the running TI Pharma project. Groundbreaking technology has been developed by partner LUMC to follow labeled live sporozoites after injection in a rodent model using in vivo real time imaging.
In this project these elements will be integrated into a clinical trial of a novel potential malaria vaccine PfSPZ-CVac, consisting of viable cryopreserved sporozoites administered to volunteers by needle injection whilst taking chloroquine. The rodent model will be used to guide decisions on the best way of sporozoite administration.
The project will provide critical information on clinical safety and protection induced by PfSPZ-CVac against two genetically different malaria parasites. Induced immune responses will be analyzed aiming at identification of bio-makers that can predict protection. This project has the potential to establish the efficacy of a very high effective malaria vaccine that could move to rapid development and licensure within a few years.
Full project title: Clinical Translation and Assessment of the Malaria Vaccine
PfPSZ-CVac Start date: 1 December 2011
End date: 31 December 2013
Goal: Evaluating the clinical safety and protection induced by a sporozoite vaccine against two genetically different malaria parasites
Principal investigator: Robert Sauerwein
Project size: 6.9 FTE's
Project budget: 2000 k€
Partners: Sanaria Inc, Radboud University Medical Center Nijmegen, Leiden University medical Center, Top Institute Pharma
“What TI Pharma can deliver from collaborations is more efficient healthcare, faster time to market and quicker patient benefit.”