title: Immunogenicity and safety of an HIV-1 lipopeptide vaccine in healthy adults: a phase 2 placebo-controlled ANRS trial.
abstract: BACKGROUND
  French National Agency for Research on AIDS and Viral Hepatitis's HIV-LIPO-5 vaccine includes five HIV-1 peptides, containing multiple CD8 and CD4 T-cell epitopes and coupled to a palmitoyl tail. Whether HIV-LIPO-5 immunogenicity varies with the dose is unknown.
  
  
  METHODS
  HIV-negative volunteers were randomized to receive HIV-LIPO-5 vaccine at 50 microg/lipopeptide (N = 32), 150 microg/lipopeptide (N = 32), 500 microg/lipopeptide (N = 33) or placebo (N = 34) at weeks 0, 4, 12 and 24. HIV-1-specific CD8 (interferon-gamma ELISpot on peripheral blood mononuclear cells cultured for 12 days) and CD4 responses (peripheral blood mononuclear cell lymphoproliferation) were assessed at baseline, after each injection and at week 48.
  
  
  RESULTS
  Local reactions were dose-dependent but no differences in systemic reactions appeared between groups. Sustained (at least on two separate occasions) CD8 response rates to at least one given HIV-1 pool were obtained in 22 of 32 (69%), 21 of 33 (64%) and 21 of 34 (62%) individuals for LIPO-5 50, 150 and 500 groups, respectively (P < or = 0.0001 for all comparisons to the placebo). Cumulative CD4 response rates were obtained in 15 of 32 (47%), 18 of 33 (55%) and 15 of 34 (44%) individuals (P < 0.0001 for all comparisons to placebo). At week 48, CD8 responses persisted in 47 of 91 (52%) HIV-LIPO-5 recipients.
  
  
  CONCLUSIONS
  Doses of 50, 150 and 500 microg of French National Agency for Research on AIDS and Viral Hepatitis's HIV-LIPO-5 vaccine were able to elicit HIV-specific sustained CD8 and CD4 T-cell responses in healthy adults. Safety is good and all doses appear appropriate in further 'prime-boost' trials.
authors.affiliation: Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Cochin, France. dominique.salmon@cch.aphp.fr
authors.forename: Dominique
authors.initials: D
authors.lastname: Salmon-Céron
authors.forename: Christine
authors.initials: C
authors.lastname: Durier
authors.forename: Corinne
authors.initials: C
authors.lastname: Desaint
authors.forename: Lise
authors.initials: L
authors.lastname: Cuzin
authors.forename: Mathieu
authors.initials: M
authors.lastname: Surenaud
authors.forename: Nadine Ben
authors.initials: NB
authors.lastname: Hamouda
authors.forename: Jean-Daniel
authors.initials: JD
authors.lastname: Lelièvre
authors.forename: Bénédicte
authors.initials: B
authors.lastname: Bonnet
authors.forename: Gilles
authors.initials: G
authors.lastname: Pialoux
authors.forename: Isabelle
authors.initials: I
authors.lastname: Poizot-Martin
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Aboulker
authors.forename: Yves
authors.initials: Y
authors.lastname: Lévy
authors.forename: Odile
authors.initials: O
authors.lastname: Launay
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000276:immunology*; D000328:Adult; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D049109:Cell Proliferation; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular / Q000276:immunology*; D007273:Injections, Intramuscular; D007371:Interferon-gamma; D055666:Lipopeptides / Q000187:drug effects / Q000276:immunology; D008297:Male; D008875:Middle Aged
chemical_list: D016915:AIDS Vaccines; D055666:Lipopeptides; D007371:Interferon-gamma