Table 2.
Results for Month 6.5 Primary and Secondary Immune Responses of Per-Protocol Vaccine Recipients
| Response Type | Variable | HR Scale | HR (95% CI) | Adjusted P | |
|---|---|---|---|---|---|
| Univariate results | |||||
| Primary variables | Cytokine-secreting T-cell | CD4+ PFS ZM96 | Per 1-SD | 1.16 (.84–1.61) | .79 |
| Binding antibody | IgG A244 V1V2 | Per 1-SD | .92 (.58–1.45) | .79 | |
| Binding antibody | IgG3 1086 V1V2 | Per 1-SD | 1.28 (.83–1.98) | .79 | |
| Cytokine-secreting T-cell | CD4+ PFS ZM96 | High vs low | 1.67 (.65–4.26) | .19 | |
| Cytokine-secreting T-cell | CD4+ PFS ZM96 | Medium vs low | 2.62 (.94–7.33) | ||
| Binding antibody | IgG A244 V1V2 | High vs low | 1.45 (.54–3.89) | .12 | |
| Binding antibody | IgG A244 V1V2 | Medium vs low | .38 (.13–1.12) | ||
| Binding antibody | IgG3 1086 V1V2 | Pos vs neg | 2.77 (1.04–7.38) | .12 | |
| Secondary variables | Cytokine-secreting T-cell | CD4+ PFS 1086 | Per 1-SD | 1.23 (.88–1.72) | 1.00 |
| Cytokine-secreting T-cell | CD4+ PFS TV1 | Per 1-SD | 1.20 (.83–1.73) | 1.00 | |
| Cytokine-secreting T-cell | CD4+ IFN-γ+/IL-2+/CD40L+ ZM96 | Per 1-SD | 1.39 (1.00–1.94) | .32 | |
| Binding antibody | IgG A1.con.env03 140 CF | Per 1-SD | 1.15 (.74–1.77) | 1.00 | |
| Binding antibody | IgG A244 gp120 | Per 1-SD | 1.08 (.72–1.63) | 1.00 | |
| Binding antibody | IgA score | Per 1-SD | 1.01 (.64–1.58) | 1.00 | |
| Cytokine-secreting T-cell | CD4+ PFS 1086 | High vs low | 1.32 (.52–3.37) | 1.00 | |
| Cytokine-secreting T-cell | CD4+ PFS 1086 | Medium vs low | 1.22 (.47–3.21) | ||
| Cytokine-secreting T-cell | CD4+ PFS TV1 | High vs low | 1.87 (.67–5.21) | 1.00 | |
| Cytokine-secreting T-cell | CD4+ PFS TV1 | Medium vs low | 1.29 (.50–3.32) | ||
| Cytokine-secreting T-cell | CD4+ IFN-γ+/IL-2+/CD40L+ ZM96 | High vs low | 2.01 (.75–5.37) | 1.00 | |
| Cytokine-secreting T-cell | CD4+ IFN-γ+/IL-2+/CD40L+ ZM96 | Medium vs low | 1.11 (.40–3.02) | ||
| Binding antibody | IgG A1.con.env03 140 CF | High vs low | 1.48 (.57–3.82) | 1.00 | |
| Binding antibody | IgG A1.con.env03 140 CF | Medium vs low | 1.10 (.57–3.93) | ||
| Binding antibody | IgG A244 gp120 | High vs low | 1.55 (.61–3.95) | 1.00 | |
| Binding antibody | IgG A244 gp120 | Medium vs low | 1.50 (.40–3.01) | ||
| Binding antibody | IgA score | High vs low | 1.45 (.53–3.97) | 1.00 | |
| Binding antibody | IgA score | Medium vs low | 1.04 (.40–2.70) | ||
| Multivariate resultsa | |||||
| Model 1, primary variables, magnitude | Cytokine-secreting T-cell | CD4+ PFS ZM96 | Per 1-SD | 1.04 (.71–1.53) | .84 |
| Binding antibody | IgG A244 V1V2 | Per 1-SD | .76 (.42–1.36) | .71 | |
| Binding antibody | IgG3 1086 V1V2 | Per 1-SD | 1.46 (.78–2.73) | .70 | |
| Model 2, primary variables, categorical | Cytokine-secreting T-cell | CD4+ PFS ZM96 | High vs low | 1.30 (.42–4.07) | .88 |
| Cytokine-secreting T-cell | CD4+ PFS ZM96 | Medium vs low | 1.33 (.38–4.61) | ||
| Binding antibody | IgG A244 | High vs low | 1.20 (.32–4.53) | .25 | |
| Binding antibody | IgG A244 | Medium vs low | .35 (.11–1.16) | ||
| Binding antibody | IgG3 1086 V1V2 | Pos vs neg | 1.88 (.52–6.77) | .66 | |
Univariate and multivariate Cox proportional hazards regression results are shown for the primary and secondary immune response variables, adjusted for the baseline covariates age (≤ 25, >25 years) and a previously derived categorical HIV risk score for women.
Abbreviations: CI, confidence interval; HR, hazard ratio; Neg, negative; Pos, positive.
Multivariate models 1 and 2 differ with respect to the immune response variables included: model 1 includes quantitative CD4+ polyfunctionality scores to ZM96, IgG binding antibody magnitude to A244, and IgG3 binding antibody magnitude to 1086 V1V2; model 2 replaces quantitative magnitude and polyfunctionality score variables with categorical low/medium/high or binary positive/negative response indicators.