Abstract
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.
Highlights
Immune response after vaccination of HIV infected individuals receiving HAART with overlapping gag peptides pulsed on autologous cells
HIV Gag specific CD4+ and CD8+ T cell responses are important for HIV immune control
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
Summary
HIV Gag specific CD4+ and CD8+ T cell responses are important for HIV immune control. Pulsing overlapping Gag peptides on autologous cells (Opal) has proven immunogenic and effective in reducing viral loads in multiple macaque studies, warranting clinical evaluation
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