Table 2.
Relationship of HZ to gpELISA Titers 6 Weeks After Vaccination
| Immunogenicity End Point | ZV Recipients (n=1164)a |
Placebo Recipients (n=1223)a |
||
|---|---|---|---|---|
| No.b | Observed Response (95% CI) | No.b | Observed Response (95% CI) | |
| GMT | ||||
| Developed HZ | 24 | 454.1 (300.2–687.0)c | 89 | 178.3 (140.0–227.1)c |
| Did not develop HZ | 1086 | 659.3 (624.1–696.6) | 1079 | 294.2 (275.7–313.9) |
| GMFR from d 1 | ||||
| Developed HZ | 24 | 1.6 (1.2–1.9) | 89 | 1.0 (0.9–1.0) |
| Did not develop HZ | 1085 | 2.3 (2.2–2.4) | 1078 | 1.0 (1.0–1.0) |
Abbreviations: CI, confidence interval; GMFR, geometric mean fold rise; GMT, geometric mean titer; gpELISA, glycoprotein enzyme-linked immunosorbent assay; HZ, herpes zoster; ZV, zoster vaccine.
a Case-cohort population, which includes the 10% immunogenicity subcohort plus all subjects who developed suspected HZ.
b Number of subjects contributing to the immunogenicity analysis; subjects who developed HZ before the 6-week date were excluded from this analysis.
c In both arms, GMT differed significantly between subjects who developed HZ and those who did not (ZV group, P = .02; placebo group, P < .01; 1-sided 2 sample t test).