Fig. 4: Correlate of risk analyses in the Vaccine Group for antibodies measured at Peak.

Analyses used eligible COVID-19 cases and non-cases in the Per-protocol Serum Immunogenicity Analysis Set in the Vaccine Group (N = 115). a, b Covariate-adjusted hazard ratios (HRs) of COVID-19 [follow-up: a 7 to 92 days post-Peak; b 7 to 230 days-post Peak] per 10-fold Peak immune marker increase. Blue squares are point estimates and horizontal lines are 95% confidence intervals. P-values are from a two-sided Wald test. Holm-Bonferroni family-wise error rate (FWER) adjusted two-sided p-values are also shown. Cases acquired a COVID-19 endpoint a 7 through 92 days post Peak or b 7 through 230 days post Peak. HRs were estimated using inverse probability sampling weighted Cox regression models; 95% confidence intervals (CIs) and two-sided Wald-based p-values are shown. Analyses adjusted for: a HIV status and baseline risk score; b whether enrolled in South Africa, HIV status, TB status, enrolment period, and baseline risk score. c–f Controlled risk plots for Vaccine Group (N = 115) antibody markers at Peak. Covariate-adjusted probability of COVID-19 by c, d 92 days post Peak or e, f 165 days post-Peak is estimated under hypothetical assignments of all participants to the Vaccine Group and the marker value on the x-axis. c, e Peak IgG Spike BA.4/5 concentration; d, f Peak nAb ID50 BA.4/5 titer. Controlled risk was estimated using a monotone-constrained nonparametric method with covariate adjustment and restricted to the middle 95% quantiles of the available marker data. Solid lines indicate point estimates; dotted lines and shading indicate pointwise 95% CIs. Horizontal gray lines: overall cumulative incidence of COVID-19 from 7 to 92 (or 165) days post-Peak in the Vaccine Group. Background kernel density plots show marker distributions at M0 or at Peak. Analyses adjusted for whether enrolled in South Africa, HIV status, TB status, enrolment period, and baseline risk score. AU, arbitrary units; FWER, family-wise error rate adjusted p-value; N, Nucleocapsid protein; nAb-ID50, 50% inhibitory serum dilution neutralizing antibody titer; Peak, 4 weeks post-last vaccine dose (M2 for Vaccine Group).