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Methods We performed a phase I, single centre, placebo-controlled, double-blinded and dose-escalating study to evaluate the safety and preliminary immunogenicity of a novel vaccine approach Opal-HIV-Gag(c). This vaccine is constituted by 120 15mer peptides, overlapping by 11 amino acids spanning the entire HIV Gag C Durban consensus sequence proteome, pulsed on white blood cells enriched from whole blood using a closed system, followed by intravenously reinfusion. Patients with well controlled HIV on HAART received four vaccinations administered at week 0, 4, 8 and 12, and were followed up for 12 weeks posttreatment. Eighteen people were enrolled in three groups: 12mg (n=6), 24mg (n=6) or matching placebo (n=6). An additional group (48mg, n=2) was not evaluable. Immunogenicity was assessed by IFNg ELIspot/ICS.

Immune response after vaccination of HIV infected individuals receiving HAART with overlapping gag peptides pulsed on autologous cells