title: EV01: a phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium.
abstract: NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag, pol, env and nef antigens, was tested in a phase I study in healthy, HIV negative volunteers in London and Lausanne. Twenty-four participants were randomised to receive NYVAC-C (20) or matching placebo (4) at weeks 0 and 4, and assessed for safety and immunogenicity over 48 weeks. There were no serious adverse events, and no clinical or laboratory abnormalities or other events that led to withdrawal, interruption or dose reduction of the NYVAC-C/placebo. Half of the 10 assessed responded in the ELISpot assay under stringent criteria, which informed the sample size for a DNA-NYVAC-C comparison to NYVAC-C alone.
authors.affiliation: Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
authors.forename: Pierre-Alexandre
authors.initials: PA
authors.lastname: Bart
authors.forename: Ruth
authors.initials: R
authors.lastname: Goodall
authors.forename: Tristan
authors.initials: T
authors.lastname: Barber
authors.forename: Alexandre
authors.initials: A
authors.lastname: Harari
authors.forename: Ana
authors.initials: A
authors.lastname: Guimaraes-Walker
authors.forename: Mona
authors.initials: M
authors.lastname: Khonkarly
authors.forename: Neil C
authors.initials: NC
authors.lastname: Sheppard
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Bangala
authors.forename: Marie-Joelle
authors.initials: MJ
authors.lastname: Frachette
authors.forename: Ralf
authors.initials: R
authors.lastname: Wagner
authors.forename: Peter
authors.initials: P
authors.lastname: Liljeström
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Kraehenbuhl
authors.forename: Marc
authors.initials: M
authors.lastname: Girard
authors.forename: Jaap
authors.initials: J
authors.lastname: Goudsmit
authors.forename: Mariano
authors.initials: M
authors.lastname: Esteban
authors.forename: Jonathan
authors.initials: J
authors.lastname: Heeney
authors.forename: Quentin
authors.initials: Q
authors.lastname: Sattentau
authors.forename: Sheena
authors.initials: S
authors.lastname: McCormack
authors.forename: Abdel
authors.initials: A
authors.lastname: Babiker
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pantaleo
authors.forename: Jonathan
authors.initials: J
authors.lastname: Weber
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000737:chemistry / Q000276:immunology*; D000328:Adult; D005260:Female; D015658:HIV Infections / Q000517:prevention & control; D015497:HIV-1 / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000737:chemistry; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000737:chemistry / Q000276:immunology* / Q000627:therapeutic use
chemical_list: D016915:AIDS Vaccines; C078787:NYVAC vaccine; D010455:Peptides; D014765:Viral Vaccines