Clinical development of placental malaria vaccines and immunoassays harmonization: a workshop report

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作者
Arnaud Chêne
Sophie Houard
Morten A. Nielsen
Sophia Hundt
Flavia D’Alessio
Sodiomon B. Sirima
Adrian J. F. Luty
Patrick Duffy
Odile Leroy
Benoit Gamain
Nicola K. Viebig
机构
[1] Université Sorbonne Paris Cité,Unité Biologie Intégrée du Globule Rouge, Laboratoire d’Excellence GR
[2] Université Paris Diderot,Ex
[3] Inserm,European Vaccine Initiative
[4] Institut National de la Transfusion Sanguine,Centre for Medical Parasitology at Department of Immunology and Microbiology, Faculty of Health and Medical Sciences
[5] UniversitätsKlinikum Heidelberg,Department of Infectious Diseases
[6] University of Copenhagen,COMUE Sorbonne Paris Cité
[7] Copenhagen University Hospital (Rigshospitalet),Laboratory of Malaria Immunology and Vaccinology
[8] Centre National de Recherche et de Formation sur le Paludisme,undefined
[9] IRD MERIT UMR 216,undefined
[10] Université Paris Descartes,undefined
[11] Faculté des Sciences Pharmaceutiques et Biologiques,undefined
[12] National Institute of Allergy and Infectious Disease,undefined
[13] National Institutes of Health,undefined
来源
关键词
Placental malaria; Vaccine development; Clinical trial; Immunoassays; Harmonization;
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摘要
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.
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