title: Clinical safety of HIV lipopeptides used as vaccines in healthy volunteers and HIV-infected adults.
abstract: BACKGROUND
  HIV-1 lipopeptides have been developed by the French National Agency for AIDS Research (ANRS) for use as candidate vaccine against HIV since 1994. Between 1996 and 2005, four different lipopeptide constructs were tested alone or in combination with recombinant canarypox HIV vaccines in 10 trials conducted in France. The aim of this study was to review clinical safety of HIV lipopeptides.
  
  
  METHODS
  A meta-analysis based on individual subject data examined clinical safety data collected in eight preventive trials and two therapeutic trials enrolling 200 HIV-1-uninfected healthy volunteers and 48 HIV-1-infected patients.
  
  
  RESULTS
  Of 248 trial participants, eight (3.2%) did not complete follow-up: seven among the 200 healthy volunteers, and one among the 48 HIV-1 infected patients. During the 354 person-years of follow-up, 860 lipopeptides injections were administered. Local reactions were common. However, in trials where lipopeptides were tested without adjuvant and appropriate diluents, none of the vaccinees experienced severe local response. Systemic reactions were generally mild and transient. No grade 4 reaction was reported; 18 subjects experienced grade 3 systemic events related to the vaccination, mainly asthenia, fever, headache and arthralgia. Multivariate analysis showed that female sex, number of injections and diluent (more reactions in 5% glucose alone than in combination with Tris-HCl buffer) significantly increased systemic reactions related to the vaccination.
  
  
  CONCLUSIONS
  These data demonstrate that reactogenicity and systemic safety of HIV lipopeptides vaccine are acceptable both in healthy volunteers and HIV-infected adults.
authors.affiliation: INSERM SC10, 16 Avenue Paul-Caillant Couturier, 94800 Villejuif, France. c.durier@vjf.unserm.fr
authors.forename: Christine
authors.initials: C
authors.lastname: Durier
authors.forename: Odile
authors.initials: O
authors.lastname: Launay
authors.forename: Vincent
authors.initials: V
authors.lastname: Meiffrédy
authors.forename: Yacine
authors.initials: Y
authors.lastname: Saïdi
authors.forename: Dominique
authors.initials: D
authors.lastname: Salmon
authors.forename: Yves
authors.initials: Y
authors.lastname: Lévy
authors.forename: Jean-Gérard
authors.initials: JG
authors.lastname: Guillet
authors.forename: Gilles
authors.initials: G
authors.lastname: Pialoux
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Aboulker
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D000328:Adult; D018771:Arthralgia / Q000139:chemically induced; D001247:Asthenia / Q000139:chemically induced; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000139:chemically induced; D015658:HIV Infections / Q000517:prevention & control*; D015497:HIV-1 / Q000276:immunology*; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007267:Injections; D008074:Lipoproteins / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D012737:Sex Factors
chemical_list: D016915:AIDS Vaccines; D008074:Lipoproteins