Table 2. Multivariate analyses of the determinants of biological outcomes in Geneva.
Multivariate analyses were conducted to assess the association between the signature and biological outcomes adjusting for the vaccine dose. Linear regression models were used. For the factor dose, placebo was the reference category (denoted “Ref”): The regression coefficients for LD and HD represent the mean difference in the biological outcome compared with placebo, adjusted for the signature. The P value parallel to the reference category is the P value for testing the global association between the vaccine dose (all doses) and the outcomes. The regression coefficients for the signature represent the mean increase in biological outcomes for an increase in signature of one unit, adjusted for the vaccine dose. For some biological outcomes (peak VSV and VSV viremia at day 1 and at day 3), a log10 transformation was applied to fulfill the assumptions of a linear regression model. n denotes the number of volunteers included in the analyses (that is, those without any missing data for the outcomes and the signature).
| Outcomes | Predictors | Estimate (SE) | P | |
|---|---|---|---|---|
|
Peak VSV (log10) (n = 112) |
Dose | Placebo | Ref | <0.001 |
| Low | 0.04 (0.16) | 0.78 | ||
| High | 1.03 (0.19) | <0.001 | ||
| Signature | Per unit | 0.20 (0.07) | 0.003 | |
| VSV viremia (log10) | ||||
| Day 1 (n = 113) | Dose | Placebo | Ref | <0.001 |
| Low | 0.01 (0.17) | 0.95 | ||
| High | 0.97 (0.21) | <0.001 | ||
| Signature | Per unit | 0.15 (0.07) | 0.035 | |
| Day 3 (n = 112) | Dose | Placebo | Ref | <0.001 |
| Low | −0.01 (0.17) | 0.97 | ||
| High | 0.68 (0.21) | 0.001 | ||
| Signature | Per unit | 0.24 (0.07) | 0.001 | |
| Lymphopenia | ||||
| Day 1 (n = 113) | Dose | Placebo | Ref | <0.001 |
| Low | −0.12 (0.06) | 0.060 | ||
| High | −0.26 (0.08) | <0.001 | ||
| Signature | Per unit | −0.19 (0.03) | <0.001 | |
| Day 3 (n = 113) | Dose | Placebo | Ref | 0.014 |
| Low | −0.14 (0.07) | 0.043 | ||
| High | −0.01 (0.08) | 0.88 | ||
| Signature | Per unit | −0.04 (0.03) | 0.13 | |
| Thrombocytopenia | ||||
| Day 1 (n = 113) | Dose | Placebo | Ref | 0.55 |
| Low | 0.00 (0.02) | 0.92 | ||
| High | −0.02 (0.03) | 0.53 | ||
| Signature | Per unit | −0.04 (0.01) | <0.001 | |
| Day 3 (n = 113) | Dose | Placebo | Ref | 0.022 |
| Low | −0.07 (0.02) | 0.008 | ||
| High | −0.08 (0.03) | 0.013 | ||
| Signature | Per unit | −0.03 (0.01) | 0.003 | |
| Monocytosis | ||||
| Day 1 (n = 113) | Dose | Placebo | Ref | 0.14 |
| Low | 0.23 (0.13) | 0.088 | ||
| High | 0.32 (0.16) | 0.049 | ||
| Signature | Per unit | −0.04 (0.06) | 0.48 | |
| Day 3 (n = 113) | Dose | Placebo | Ref | 0.048 |
| Low | 0.32 (0.14) | 0.025 | ||
| High | 0.18 (0.17) | 0.30 | ||
| Signature | Per unit | −0.04 (0.06) | 0.45 | |
| Neutropenia | ||||
| Day 1 (n = 112) | Dose | Placebo | Ref | 0.59 |
| Low | 0.10 (0.13) | 0.44 | ||
| High | 0.02 (0.15) | 0.88 | ||
| Signature | Per unit | 0.15 (0.05) | 0.006 | |
| Day 3 (n = 111) | Dose | Placebo | Ref | <0.001 |
| Low | −0.26 (0.07) | <0.001 | ||
| High | −0.34 (0.09) | <0.001 | ||
| Signature | Per unit | −0.05 (0.03) | 0.10 | |