Transient and treatment specific lymphopenia after vaccination.

<p>Total lymphocyte counts were performed before, during and at follow up after vaccination as indicated on the x-axis for the three groups (0 mg, 12 mg and 24 mg) and shown as mean values (million lymphocytes per ml whole blood) for the 6 subjects within each group with normal high and low values for HIV positive individuals indicated by dotted lines (A). Arrows indicate vaccinations. The percent (%) change of lymphocyte count from baseline (week 0) is shown as mean values for the three dose groups with error bars representing standard error of mean (SEM) (B). Only one subject (024) was available for the 48 mg dose group at week 0 and 4.</p

OPAL-HIV-Gag(c) and CMV peptide pool specific CD4+ T-cell responses before and after vaccination.

<p>All six subjects from each dose group (0 mg, 12 mg and 24 mg) were tested for OPAL-HIV-Gag(c) specific or no peptide (mock) responses by ICS shown as IFNγ+/MIP1β+ double positive CD4+ T-cells processed from frozen PBMCs derived at week 0, 13 and 14 after first vaccination expressed as the mean of triplicate stimulations (A) and expressed as median values within dose groups with error bars representing inter quartile ranges for OPAL-HIV-Gag(c) (B) and for CMV specific CD4+ T-cell responses (C).</p

OPAL-HIV-Gag(c) and CMV peptide pool specific CD8+ T-cell responses before and after vaccination.

<p>All six subjects from each dose group (0 mg, 12 mg and 24 mg) were tested for OPAL-HIV-Gag(c) specific or no peptide (no stimulation) responses by ICS shown as IFNγ+/MIP1β+ double positive CD8+ T-cells processed from frozen PBMCs derived at week 0, 13 and 14 after first vaccination expressed as the mean of triplicate stimulations (A) and expressed as median values within dose groups with error bars representing inter quartile ranges for OPAL-HIV-Gag(c) (B) and for CMV specific CD8+ T-cell responses (C).</p

OPAL-HIV-Gag(c) peptide pool specific responses before and after vaccination.

<p>All six subjects from each dose group (0 mg, 12 mg and 24 mg) were tested for OPAL-HIV-Gag(c) specific or no peptide (mock) responses by IFNγ ex vivo ELIspot performed from fresh cells at week 0, 10, 12, 13, 14 and 16 after first vaccination expressed as the mean SFU per million cells of triplicate stimulations (A) and expressed as median values within dose groups with error bars representing inter quartile ranges (B).</p

Magnitude and expansion potential of pre-existing OPAL-HIV-Gag(c) specific responses.

<p>Eighteen subjects completing the study were tested for IFNγ ELIspot responses expressed as SFU per million inpuT-cells to OPAL-HIV-Gag(c) peptides or mock (media only) from fresh ex vivo PBMCs (A) or from 10 day cultured OPAL-HIV-Gag(c) peptide expanded PBMCs (B) from screening samples available at 2–6 weeks prior to baseline. The expansion capacity was determined as the fold change of magnitude for the cultured ELIspot over the ex vivo ELIspot (C). ND not done.</p

Study subject disposition and allocation to dosing cohorts.

<p>(A): Thirty eight subjects were screened for the study, with 23 randomised and 18 completing the study. (B): Diagram showing the planned study allocation to dose escalating cohorts (5∶2) and with sentinel cohorts (1∶1) shown for the 12 mg, 24 mg and 48 mg dose groups.</p

HIV-1 seropositive subjects under HAART treatment used for ‘Opal-HIV-Gag(c)’ vaccine administration.

a<p>Values obtained at baseline defined as day of first vaccination.</p>b<p>Withdrawn from study after two administrations (014) or after one administration (019 and 024).</p