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Heidelberg, Germany

Leroy O.,European Vaccine Initiative EVI | Geels M.,European Vaccine Initiative EVI | Korejwo J.,European Vaccine Initiative EVI | Dodet B.,Dodet Bioscience | And 2 more authors.

To consolidate the integration of the fragmented European vaccine development landscape, TRANSVAC - the European Network of Vaccine Research and Development, funded by the European Commission (EC) - has initiated the development of a roadmap through a process of stakeholder consultation. The outcome of this consultation highlighted the need for transnational cooperation and the opportunities that could be generated by such efforts. This cooperation can be achieved through the establishment of a European Vaccine Research and Development Infrastructure (EVRI). EVRI will support cooperation between existing vaccine Research and Development (R&D) organisations from the public and private sector and other networks throughout Europe. It will become sustainable over time by receiving support from multiple sources including the EC, European Union (EU) Member States, European vaccine companies, EVRI partner organisations, and by income generated. Different stakeholders have demonstrated support for the concept of a vaccine infrastructure and agree that such an infrastructure can function as leverage institution between public and private institutions thus making significant contributions to the vaccine field as a whole in its quest to develop vaccines. EVRI will be launched in three phases: preparatory (during which the legal and administrative framework will be defined and a business plan will be elaborated), implementation and operational. If sufficient political and financial commitment can be secured from relevant national and European entities as well as from the private sector and other stakeholders, it could enter into operational phase from 2017 onwards. In conclusion, EVRI can make vaccine R&D more efficient and help address European and global health challenges, help alleviate the burden and spread of infectious diseases, thus contributing to the sustainability of public healthcare systems. © 2014 The Authors. Source

Chitnis C.E.,International Center for Genetic Engineering and Biotechnology | Chitnis C.E.,Institute Pasteur Paris | Mukherjee P.,International Center for Genetic Engineering and Biotechnology | Mehta S.,Malaria Vaccine Development Program MVDP | And 18 more authors.

Background: A phase I randomised, controlled, single blind, dose escalation trial was conducted to evaluate safety and immunogenicity of JAIVAC-1, a recombinant blood stage vaccine candidate against Plasmodium falciparum malaria, composed of a physical mixture of two recombinant proteins, PfMSP-119, the 19 kD conserved, C-terminal region of PfMSP-1 and PfF2 the receptor-binding F2 domain of EBA175. Method: Healthy malaria naïve Indian male subjects aged 18-45 years were recruited from the volunteer database of study site. Fifteen subjects in each cohort, randomised in a ratio of 2:1 and meeting the protocol specific eligibility criteria, were vaccinated either with three doses (10μg, 25μg and 50μg of each antigen) of JAIVAC-1 formulated with adjuvant Montanide ISA 720 or with standard dosage of Hepatitis B vaccine. Each subject received the assigned vaccine in the deltoid muscle of the upper arms on Day 0, Day 28 and Day 180. Results: JAIVAC-1 was well tolerated and no serious adverse event was observed. All JAIVAC-1 subjects sero-converted for PfF2 but elicited poor immune response to PfMSP-1 19. Doseresponse relationship was observed between vaccine dose of PfF2 and antibody response. The antibodies against PfF2 were predominantly of IgG1 and IgG3 isotype. Sera from JAIVAC-1 subjects reacted with late schizonts in a punctate pattern in immunofluorescence assays. Purified IgG from JAIVAC-1 sera displayed significant growth inhibitory activity against Plasmodium falciparum CAMP strain. Conclusion: Antigen PfF2 should be retained as a component of a recombinant malaria vaccine but PfMSP-1 19 construct needs to be optimised to improve its immunogenicity. © 2015, Public Library of Science. All rights reserved. Source

Murphy S.C.,University of Washington | Hermsen C.C.,Radboud University Nijmegen | Douglas A.D.,University of Oxford | Edwards N.J.,University of Oxford | And 15 more authors.

Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA) program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log 10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide. Source

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