Table 1.
HVTN 087 study schema.
Fig 1.
HVTN 087 CONSORT flow diagram.
Table 2.
Study population baseline characteristics.
Fig 2.
Visual analog scale pain scores after DNA/placebo and VSV-Gag/placebo vaccine delivery.
Participants rated their pain between 0 (no pain) and 10 (worst possible pain). The graph shows the mean and 95% CI of VAS scores at 3 timepoints indicating minutes after injection, shown by injection visits and treatment arms. The 95% CI was estimated using t-distribution with n-1 degrees of freedom. Pain scores were maximal at 0 minutes after electroporation, and significantly lower in T4 compared to other treatment arms at that timepoint.
Fig 3.
Maximum local reactogenicity, prime vs boost, by treatment group.
Bar graphs show the percentage of participants in each treatment group reporting the specified maximum severity during the reactogenicity period. Left panels (Prime) indicate the maximum severity over all 3 priming injections. P values indicated are for comparisons across all treatment arms. The increased reactogenicity of the Prime compared to Boost is significant for T1-T4 (p<0.01), and the increased reactogenicityexperienced by T1-T4 compared to placebo for the VSV-Gag boost, upper right panel, is significant (p = 0.01).
Fig 4.
Maximum systemic reactogenicity, prime vs boost, by treatment group.
Bar graphs show the percentage of participants in each treatment group reporting the specified maximum severity during the reactogenicity period. Left panels (Prime) indicate the maximum severity over all 3 priming injections. P values indicated are for comparisons across all treatment arms. Maximum systemic symptoms were significantly more severe in T1-T4 groups than the placebo group following the VSV-Gag boost.
Table 3.
Related adverse events in treatment groups with or without IL-12 pDNA adjuvant.
Fig 5.
Decreases in peripheral blood absolute lymphocyte counts and absolute neutrophil counts after VSV-Gag.
Counts at 1 and 3 days after VSV-Gag boost were assessed for Groups 1 and 3 only. Placebo data from P1 and P3 are pooled, shown in blue. Data from T1 and T3 are displayed together, with T1 values in black and T3 in red. Bold lines represent median values for each treatment group, superimposed on the individual profiles.
Fig 6.
Changes in numbers of cell populations assessed by Trucount™ after vaccination.
Absolute counts for CD3+ T cells (A), NK cells (B) and granulocytes (C) are shown. Placebo data from P1 and P3 are pooled, shown in blue. Data from T1 and T3 are displayed together, with T1 values in black and T3 in red. Bold lines represent median values for each treatment group, superimposed on the individual profiles.
Fig 7.
Willingness to undergo electroporation, by treatment group.
Bar graphs show the percentage of participants in each treatment group reporting willingness to undergo EP, in response to these questions, as assessed 2 weeks after the last injection with EP: Left panel: How willing would you be to undergo electroporation if it were required for a new vaccine against a serious disease if you were at risk for that disease? Right panel: How willing would you be to undergo electroporation if it increased the effectiveness of a vaccine we already have, such as the influenza vaccine?