Table 1.
Summary of wk28/wk1 immunological predictors of Vacc-4x effect.
| Assay | Biomarker | Endpoint | Groupa | Effectb (95% CI) | Interaction p (q) value |
|---|---|---|---|---|---|
| Luminex | IFN-γ | Week 44 VL | 25%-ile | 0.444 (− 0.265, 1.154) | 0.047 (0.070) |
| 75%-ile | − 0.376 (− 0.921, 0.169) | ||||
| TNF-α | Week 44 VL | 25%-ile | 0.223 (− 0.326, 0.772) | 0.045 (0.070) | |
| 75%-ile | − 0.288 (− 0.806, 0.231) | ||||
| Week 48 VL | 25%-ile | 0.349 (− 0.239, 0.936) | 0.028 (0.077) | ||
| 75%-ile | − 0.246 (− 0.801, 0.308) | ||||
| Week 52 VL | 25%-ile | 0.347 (− 0.370, 1.064) | 0.037 (0.074) | ||
| 75%-ile | − 0.324 (− 0.995, 0.347) | ||||
| IL-6 binary | Week 48 VL | IL6 < median | 0.572 (− 0.122, 1.267) | 0.017 (0.052) | |
| IL6 ≥ median | − 0.576 (− 1.254, 0.101) | ||||
| CFSE | CD4+ binary | Week 48 CD4 | CD4+ < median | 0.141 (0.013, 0.269) | 0.036 (0.036) |
| CD4+ ≥ median | − 0.062 (− 0.203, 0.079) | ||||
| Week 52 CD4 | CD4+ < median | 0.123 (0.002, 0.244) | 0.040 (0.080) | ||
| CD4+ ≥ median | − 0.065 (− 0.193, 0.063) |
a
Group: for continuous markers, Group indicates the 25th and 75th percentiles of the identified marker; for binary markers, Group indicates the dichotomized subgroups based on the identified marker.
b
Effect: the effect was estimated as the log10 difference between Vacc-4x and placebo in the given Group. P-values (< 0.05) and q values (< 0.1) were considered significant.