title: Clinical development of placental malaria vaccines and immunoassays harmonization: a workshop report.
abstract: Placental malaria caused by Plasmodium falciparum infection constitutes a major health problem manifesting as severe disease and anaemia in the mother, impaired fetal development, low birth weight or spontaneous abortion. Prevention of placental malaria currently relies on two key strategies that are losing efficacy due to spread of resistance: long-lasting insecticide-treated nets and intermittent preventive treatment during pregnancy. A placental malaria vaccine would be an attractive, cost-effective complement to the existing control tools. Two placental malaria vaccine candidates are currently in Phase Ia/b clinical trials. During two workshops hosted by the European Vaccine Initiative, one in Paris in April 2014 and the other in Brussels in November 2014, the main actors in placental malaria vaccine research discussed the harmonization of clinical development plans and of the immunoassays with a goal to define standards that will allow comparative assessment of different placental malaria vaccine candidates. The recommendations of these workshops should guide researchers and clinicians in the further development of placental malaria vaccines.
authors.affiliation: Unité Biologie Intégrée du Globule Rouge, Laboratoire d'Excellence GR-Ex, Université Sorbonne Paris Cité, Université Paris Diderot, Inserm, Institut National de la Transfusion Sanguine, Paris, France.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Chêne
authors.affiliation: European Vaccine Initiative, UniversitätsKlinikum Heidelberg, Voßstraße 2, 69115, Heidelberg, Germany.
authors.forename: Sophie
authors.initials: S
authors.lastname: Houard
authors.affiliation: Centre for Medical Parasitology at Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.|Department of Infectious Diseases, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.
authors.forename: Morten A
authors.initials: MA
authors.lastname: Nielsen
authors.affiliation: European Vaccine Initiative, UniversitätsKlinikum Heidelberg, Voßstraße 2, 69115, Heidelberg, Germany.
authors.forename: Sophia
authors.initials: S
authors.lastname: Hundt
authors.affiliation: European Vaccine Initiative, UniversitätsKlinikum Heidelberg, Voßstraße 2, 69115, Heidelberg, Germany.
authors.forename: Flavia
authors.initials: F
authors.lastname: D'Alessio
authors.affiliation: Centre National de Recherche et de Formation sur le Paludisme, 01 BP 2208, Ouagadougou 01, Burkina Faso.
authors.forename: Sodiomon B
authors.initials: SB
authors.lastname: Sirima
authors.affiliation: IRD MERIT UMR 216, 75006, Paris, France.|COMUE Sorbonne Paris Cité, Université Paris Descartes, Faculté des Sciences Pharmaceutiques et Biologiques, 75270, Paris, France.
authors.forename: Adrian J F
authors.initials: AJ
authors.lastname: Luty
authors.affiliation: Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Disease, National Institutes of Health, Rockville, MD, USA.
authors.forename: Patrick
authors.initials: P
authors.lastname: Duffy
authors.affiliation: European Vaccine Initiative, UniversitätsKlinikum Heidelberg, Voßstraße 2, 69115, Heidelberg, Germany.
authors.forename: Odile
authors.initials: O
authors.lastname: Leroy
authors.affiliation: Unité Biologie Intégrée du Globule Rouge, Laboratoire d'Excellence GR-Ex, Université Sorbonne Paris Cité, Université Paris Diderot, Inserm, Institut National de la Transfusion Sanguine, Paris, France.
authors.forename: Benoit
authors.initials: B
authors.lastname: Gamain
authors.affiliation: European Vaccine Initiative, UniversitätsKlinikum Heidelberg, Voßstraße 2, 69115, Heidelberg, Germany. nicola.viebig@euvaccine.eu.
authors.forename: Nicola K
authors.initials: NK
authors.lastname: Viebig
mesh_terms: D001530:Belgium; D017321:Clinical Trials, Phase I as Topic; D004493:Education; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D017780:Malaria Vaccines / Q000276:immunology* / Q000302:isolation & purification*; D016778:Malaria, Falciparum / Q000175:diagnosis* / Q000517:prevention & control*; D010297:Paris; D010922:Placenta Diseases / Q000175:diagnosis* / Q000517:prevention & control*; D063245:Plant Development; D011247:Pregnancy
chemical_list: D017780:Malaria Vaccines
keywords: Clinical trial; Harmonization; Immunoassays; Placental malaria; Vaccine development