Table 1.
RV158 Study Design.
Figure 1.
Consort clinical trial participant flow diagram (panel A).
Chronological schematic diagram showing all pre-enrollment, vaccination and blood collection visits for RV158 (panel B). Immunogenicity testing visits 3, 6, 8, 9 and 10 correspond to days 0, 42, 98, 168 and 252 post-vaccination initiation respectively.
Figure 2.
Systemic and local vaccine related reactogenicity for each dose and route of vaccination.
The number and percent of subjects experiencing one or more local (panel A) or systemic (panel B) reactions is shown for each group after stratification by severity. The most severe reaction experienced by a volunteer determined the stratification into none, moderate, mild or severe categories. No serious or life threatening adverse events were reported.
Table 2.
Cross-sectional frequency of positive CD8 CTL responses as measured in the 51Cr-release assay.
Table 3.
Cross-sectional vaccine responsiveness as measured by the Interferon-γ Elispot assay*.
Figure 3.
Lymphocyte proliferation responses for each dose and route.
Lymphocyte proliferation responses against recombinant proteins (TH023 gp140 and LAI p24) are shown for all doses and routes of vaccination (panels A and B). HIV whole inactivated virus (WIV) antigens CM235WIV (CRF01_AE vaccine matched isolate) and MNWIV (subtype B heterologous isolate) are shown for all doses and routes of vaccination in panels C and D respectively. The Y-axis represents the LSI (scale = log2) and the dotted line designates an LSI of 5 (cut-off for positive responses). Blue and red circles represent pre- and post-vaccination (day 0 and day 252) samples respectively.
Table 4.
Cross-sectional vaccine responsiveness by Whole Blood ICS assay*.
Figure 4.
Cumulative analysis of all qualitative cellular immune response assays.
The number of positive responders for HIV antigens (Env or Gag) in the 51Cr-release, Elispot, lymphocyte proliferation and whole blood ICS assays was tallied for all groups and compared with the placebo recipients. The figure graphically displays the summed cumulative positive responders for each of the 4 assay platforms. The total number of tests performed in each group is denoted below the dose and route. The top and bottom tables summarize the statistical analyses for Env and Gag respectively.
Figure 5.
Multifunctional flow cytometry analysis for HIV Env-specific T cells.
Analysis was based on the cumulative positive cells in all Boolean subsets for all volunteers who were scored as positive by single cytokine analysis in the high-dose (108 pfu) intra-muscular vaccine recipients (Table 5). The legend shows the Pie Chart arcs representing each cytokine (or function). Pie Chart wedges show the relative sizes of the subsets of cells expressing the combination of functions represented in the surrounding Pie chart arcs.
Table 5.
Multi-Functional Flow Cytometry Results (Env peptide pool responses)*.
Table 6.
Geometric Mean Antibody Titers and Response Frequency to HIV Proteins and Vaccinia*.
Table 7.
Cumulative frequency of post-vaccination positive ADCC responses.