title: Randomized double-blind controlled Phase I/IIa trial to assess the efficacy of malaria vaccine PfCS102 to protect against challenge with P. falciparum.
abstract: The aim of this Phase I/IIa double-blind controlled trial was to test the efficacy of the sporozoite-based malaria vaccine PfCS 282-383 (PfCS102) to protect against Plasmodium falciparum parasitaemia. 16 volunteers were randomized to receive twice 30 μg of PfCS102 formulated in Montanide ISA 720 or ISA 720 alone (control). Two weeks after 2nd immunization, volunteers were challenged using 5 infected mosquitoes. All vaccinees developed antibodies against PfCS102 versus none control. 8/8 vaccinees and 6/6 controls challenged developed malaria parasitaemia. The duration from infection to onset of patent parasitaemia was similar in both groups (214 h in vaccinees and 216 in controls). PfCS102 is safe and immunogenic but provides no protection against artificial challenge in its current formulation.
authors.affiliation: Department of Ambulatory Care and Community Medicine, University of Lausanne, Switzerland. Blaise.genton@hospvd.ch
authors.forename: Blaise
authors.initials: B
authors.lastname: Genton
authors.forename: Valérie
authors.initials: V
authors.lastname: D'Acremont
authors.forename: Floriana
authors.initials: F
authors.lastname: Lurati-Ruiz
authors.forename: Daniele
authors.initials: D
authors.lastname: Verhage
authors.forename: Régine
authors.initials: R
authors.lastname: Audran
authors.forename: Cornelus
authors.initials: C
authors.lastname: Hermsen
authors.forename: Liselotte
authors.initials: L
authors.lastname: Wolters
authors.forename: Christophe
authors.initials: C
authors.lastname: Reymond
authors.forename: François
authors.initials: F
authors.lastname: Spertini
authors.forename: Robert
authors.initials: R
authors.lastname: Sauerwein
mesh_terms: D000328:Adult; D000818:Animals; D000913:Antibodies, Protozoan / Q000097:blood; D009033:Culicidae; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017780:Malaria Vaccines / Q000276:immunology*; D016778:Malaria, Falciparum / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D018512:Parasitemia / Q000276:immunology / Q000517:prevention & control*; D010446:Peptide Fragments / Q000276:immunology*; D010963:Plasmodium falciparum / Q000276:immunology; D015800:Protozoan Proteins / Q000276:immunology*; D055815:Young Adult
chemical_list: D000913:Antibodies, Protozoan; D017780:Malaria Vaccines; D010446:Peptide Fragments; D015800:Protozoan Proteins; C432063:circumsporozoite protein (282-383), Plasmodium falciparum