title: Safety, immunogenicity and efficacy of a pre-erythrocytic malaria candidate vaccine, ICC-1132 formulated in Seppic ISA 720.
abstract: ICC-1132, a recombinant virus-like particle comprising of a modified hepatitis B core protein with a B cell (NANP) and two T cell epitopes of Plasmodium falciparum circumsporozoite protein (CSP), was administered i.m. as a single 50 microg dose in Seppic ISA 720 to 11 volunteers. Local reactogenicity and systemic side effects were acceptable with the predominant finding being mild pain at the injection site. This regimen induced anti-NANP antibodies in 10/11 and modest T cell responses. There was no evidence of protection from experimental challenge with P. falciparum sporozoites. Other formulations and/or multi-dose regimens will be required to enhance the immunogenicity and efficacy of ICC-1132.
authors.affiliation: Nuffield Department of Clinical Medicine, Centre for Clinical Vaccinology and Tropical Medicine, Oxford University, Old Road, Headington, Oxford OX3 7LJ, UK. Michael.walther@ndm.ox.ac.uk
authors.forename: Michael
authors.initials: M
authors.lastname: Walther
authors.forename: Susanna
authors.initials: S
authors.lastname: Dunachie
authors.forename: Sheila
authors.initials: S
authors.lastname: Keating
authors.forename: Jenni M
authors.initials: JM
authors.lastname: Vuola
authors.forename: Tamara
authors.initials: T
authors.lastname: Berthoud
authors.forename: Annette
authors.initials: A
authors.lastname: Schmidt
authors.forename: Carolin
authors.initials: C
authors.lastname: Maier
authors.forename: Laura
authors.initials: L
authors.lastname: Andrews
authors.forename: Rikke F
authors.initials: RF
authors.lastname: Andersen
authors.forename: Sarah
authors.initials: S
authors.lastname: Gilbert
authors.forename: Ian
authors.initials: I
authors.lastname: Poulton
authors.forename: Daniel
authors.initials: D
authors.lastname: Webster
authors.forename: Filip
authors.initials: F
authors.lastname: Dubovsky
authors.forename: Eveline
authors.initials: E
authors.lastname: Tierney
authors.forename: Pramod
authors.initials: P
authors.lastname: Sarpotdar
authors.forename: Simon
authors.initials: S
authors.lastname: Correa
authors.forename: Angela
authors.initials: A
authors.lastname: Huntcooke
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Butcher
authors.forename: Jack
authors.initials: J
authors.lastname: Williams
authors.forename: Robert E
authors.initials: RE
authors.lastname: Sinden
authors.forename: George B
authors.initials: GB
authors.lastname: Thornton
authors.forename: Adrian V S
authors.initials: AV
authors.lastname: Hill
mesh_terms: D000328:Adult; D000595:Amino Acid Sequence; D000818:Animals; D018984:Epitopes, T-Lymphocyte / Q000008:administration & dosage / Q000276:immunology; D004912:Erythrocytes / Q000276:immunology* / Q000469:parasitology*; D005260:Female; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D006801:Humans; D017780:Malaria Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000235:genetics / Q000276:immunology*; D016778:Malaria, Falciparum / Q000276:immunology* / Q000469:parasitology / Q000517:prevention & control; D008297:Male; D010963:Plasmodium falciparum / Q000276:immunology*; D034101:Sporozoites / Q000276:immunology
chemical_list: D018984:Epitopes, T-Lymphocyte; D017780:Malaria Vaccines