title: EV02: a Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone.
abstract: The aim of this randomised controlled trial was to see if the addition of 4 mg/ml DNA-C priming given by the intramuscular route at weeks 0 and 4 to NYVAC-C at weeks 20 and 24, safely increased the proportion of participants with HIV-specific T-cell responses measured by the interferon (IFN)-gamma ELISpot assay at weeks 26 and/or 28 compared to NYVAC-C alone. Although 2 individuals discontinued after the first DNA-C due to adverse events (1 vaso-vagal; 1 transient, asymptomatic elevation in alanine transaminase), the vaccines were well tolerated. Three others failed to complete the regimen (1 changed her mind; 2 lost to follow-up). Of the 35 that completed the regimen 90% (18/20) in the DNA-C group had ELISpot responses compared to 33% (5/15) that received NYVAC-C alone (p=0.001). Responses were to envelope in the majority (21/23). Of the 9 individuals with responses to envelope and other peptides, 8 were in the DNA-C group. These promising results suggest that DNA-C was an effective priming agent, that merits further investigation.
authors.affiliation: MRC Clinical Trials Unit, 222 Euston Road, London NW1 2DA, UK. smc@ctu.mrc.ac.uk
authors.forename: Sheena
authors.initials: S
authors.lastname: McCormack
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Stöhr
authors.forename: Tristan
authors.initials: T
authors.lastname: Barber
authors.forename: Pierre-Alexandre
authors.initials: PA
authors.lastname: Bart
authors.forename: Alexandre
authors.initials: A
authors.lastname: Harari
authors.forename: Christiane
authors.initials: C
authors.lastname: Moog
authors.forename: Donatella
authors.initials: D
authors.lastname: Ciuffreda
authors.forename: Cristina
authors.initials: C
authors.lastname: Cellerai
authors.forename: Miranda
authors.initials: M
authors.lastname: Cowen
authors.forename: Romilda
authors.initials: R
authors.lastname: Gamboni
authors.forename: Séverine
authors.initials: S
authors.lastname: Burnet
authors.forename: Ken
authors.initials: K
authors.lastname: Legg
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Brodnicki
authors.forename: Hans
authors.initials: H
authors.lastname: Wolf
authors.forename: Ralf
authors.initials: R
authors.lastname: Wagner
authors.forename: Jonathan
authors.initials: J
authors.lastname: Heeney
authors.forename: Marie-Joëlle
authors.initials: MJ
authors.lastname: Frachette
authors.forename: Jim
authors.initials: J
authors.lastname: Tartaglia
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 / Q000276:immunology / Q000627:therapeutic use*; D000328:Adult; D000956:Antigens, Viral / Q000096:biosynthesis / Q000235:genetics / Q000276:immunology*; D015195:Drug Design; D005260:Female; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control*; D015497:HIV-1 / Q000145:classification / Q000235:genetics / Q000276:immunology; D006801:Humans; D007117:Immunization, Secondary; D007273:Injections, Intramuscular; D008297:Male; D012449:Safety; D014765:Viral Vaccines / Q000008:administration & dosage / Q000737:chemistry* / Q000276:immunology*; D054299:env Gene Products, Human Immunodeficiency Virus / Q000235:genetics
chemical_list: D016915:AIDS Vaccines; D000956:Antigens, Viral; C078787:NYVAC vaccine; D014765:Viral Vaccines; D054299:env Gene Products, Human Immunodeficiency Virus