Table 1. Cell mediated activities in the DNA/Ad and AdCA trials at post-Ad time point (4–5 days before challenge).
ELISpot sfc/m | ICS/Flow cytometry | |||||||
CD8+ % | CD8+ CM % | CD8+ EM % | ||||||
CSP | AMA1 | CSP | AMA1 | CSP | AMA1 | CSP | AMA1 | |
A. DNA/Ad | ||||||||
Protected volunteers | ||||||||
v06 | 80 | 312 | <0.03 | 0.08 | <0.03 | 0.04 | <0.03 | <0.03 |
v10 | 55 | 810 | <0.03 | 0.22 | <0.03 | 0.09 | <0.03 | 0.07 |
v11 | 408 | 1046 | 0.21 | 0.98 | 0.08 | 0.21 | 0.05 | 0.46 |
v18 | 398 | 1270 | 0.10 | 0.52 | 0.06 | 0.17 | <0.03 | 0.27 |
No. positive1/total number | 2/4 | 4/4 | 2/4 | 3/4 | 2/4 | 3/4 | 1/4 | 3/4 |
Non-protected volunteers | ||||||||
Geometric mean | 68 | 262 | 0.04 | 0.11 | <0.03 | 0.05 | <0.03 | <0.03 |
Range | 13–217 | 88–787 | <0.03–0.293 | 0.05–0.19 | <0.03–0.133 | <0.03–0.16 | <0.03–0.03 | <0.03–0.07 |
No. positive1/total number | 2/11 | 8/11 | 2/11 | 8/11 | 2/11 | 5/11 | 0/11 | 0/11 |
No. with higher activity than highest protected2 | 0/11 | 0/11 | 13/11 | 0/11 | 13/11 | 0/11 | 0/11 | 0/11 |
B. AdCA Non-protected | ||||||||
Geometric mean | 273 | 1303 | 0.12 | 0.49 | 0.05 | 0.31 | <0.03 | 0.08 |
Range | 38–2550 | 435–4594 | 0.05–0.57 | 0.13–2.44 | 0–0.38 | 0.08–1.54 | <0.03–0.09 | <0.03–0.33 |
No. positive1/total number | 14/18 | 18/18 | 13/16 | 16/16 | 8/16 | 15/16 | 3/16 | 10/16 |
No. with higher activity than highest protected2 | 5/18 | 11/18 | 5/16 | 2/16 | 5/16 | 11/16 | 3/16 | 0/164 |
C. Comparisons of geometric mean activities of non-protected volunteers | ||||||||
DNA/Ad Non-protected: ADCA Non-protected p value5 | 0.0018 | <0.0001 | 0.0069 | 0.0002 | 0.0025 | 0.0001 | 0.0500 | 0.0014 |
A volunteer was considered positive for an assay if activity to one or more CSP or AMA1 peptide pools was positive (see Methods). For individual protected volunteers, positive activities are in bold.
The number of volunteers with values higher than the highest value among the four protected DNA/Ad volunteers.
Highest values are for v15.
Two protected volunteers (v10 and v18) were lower than the highest AdCA activity.
p value: non-protected volunteers were included in the comparison. Statistical comparisons are included as an exploratory analysis, since the different trials were not designed or powered for a formal statistical comparison. No. = Number.