Table 2.
Association with CD4 count at the time of first vaccination. Odds ratio and adjusted odds ratio, by fitting a logistic regression model, of the probability of failing to achieve a robust/above-average anti-S/RBD response post-vaccination, with VE90% (Panel A) and OCOnAbs (Panel B) endpoints.
| Panel A (VE90% Endpoint) |
Unadjusted Odds Ratio (95% CI) | p-Value | Adjusted * Odds Ratio (95% CI) | p-Value | & Type III p-Value |
|---|---|---|---|---|---|
| CD4 count at T1 | Failed to achieve VE90% after primary cycle (T3) | ||||
| HCD4 | 1 | 1 | 0.029 | ||
| ICD4 | 1.80 (1.36, 2.38) | <0.001 | 1.61 (0.92, 2.81) | 0.097 | |
| LCD4 | 3.84 (2.12, 6.97) | <0.001 | 3.36 (1.23, 9.16) | 0.018 | |
| Per 1 SD lower (log2 scale) | 1.65 (1.42, 1.91) | <0.001 | 1.71 (1.24, 2.36) | 0.001 | |
| CD4 count at T1 | Failed to achieve VE90% after first booster dose (T5) | ||||
| HCD4 | 1 | 1 | 0.937 | ||
| ICD4 | 1.37 (0.89, 2.13) | 0.157 | 0.91 (0.41, 2.03) | 0.814 | |
| LCD4 | 2.00 (1.08, 3.72) | 0.028 | 0.81 (0.24, 2.75) | 0.733 | |
| Per 1 SD lower (log2 scale) | 1.42 (1.16, 1.74) | <0.001 | 1.19 (0.78, 1.83) | 0.421 | |
| Panel B (OCOnAbs Endpoint) |
Unadjusted OR
(95% CI) |
p -Value | Adjusted * OR (95% CI) | p -Value | & Type III p-Value |
| CD4 count at T1 | Failed to achieve OCOnAbs after primary cycle (T3) | ||||
| HCD4 | 1 | 1 | 0.367 | ||
| ICD4 | 1.60 (1.18, 2.18) | 0.003 | 1.53 (0.84, 2.78) | 0.162 | |
| LCD4 | 2.90 (1.51, 5.58) | 0.001 | 1.30 (0.47, 3.54) | 0.612 | |
| Per 1 SD lower (log2 scale) | 1.46 (1.25, 1.72) | <0.001 | 1.34 (0.96, 1.85) | 0.082 | |
| CD4 count at T1 | Failed to achieve OCOnAbs after first booster dose (T5) | ||||
| HCD4 | 1 | 1 | 0.925 | ||
| ICD4 | 1.29 (0.84, 1.98) | 0.244 | 0.87 (0.40, 1.89) | 0.730 | |
| LCD4 | 1.72 (0.93, 3.19) | 0.083 | 0.83 (0.26, 2.67) | 0.759 | |
| Per 1 SD lower (log2 scale) | 1.35 (1.11, 1.65) | 0.003 | 1.19 (0.79, 1.80) | 0.409 | |
* Adjusted for age, VL ≤ 50 cps/mL at 1st vaccination, no. of comorbidities and nadir CD4 count; & from the adjusted model; abbreviations: HCD4, high CD4 count (>500/mm3); ICD4, intermediate CD4 count (200–500/mm3); LCD4, low CD4 count (0–200/mm3); OR, odds ratio.