Table 3.
VZV-Specific Antibody Observed Response by gpELISA in Auto-HSCT Recipients and Patients With STMc, by HZ Confirmation (Per-Protocol Population)
| gpELISA Units/mLa | Patients With Confirmed HZ | Patients Without Confirmed HZ | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ZVIN | Placebo | ZVIN | Placebo | |||||||
| No. | Observed Response (90% CI) | No. | Observed Response (90% CI) | No. | Observed Response (90% CI) | No. | Observed Response (90% CI) | |||
| Auto-HSCT | Number of patients vaccinated: ZVIN, 554; placebo, 556 | |||||||||
| Baseline | GMT | 28 | 81.3 (51.5–128.4) | 75 | 138.3 (112.9–169.5) | 346 | 109.2 (96.9–123.0) | 309 | 108.3 (96.3–121.8) | |
| ~28 days post–dose 4 | GMT | 4 | 152.2 (9.2–2521.6) | 14 | 108.0 (64.1–181.7) | 98 | 246.4 (189.6–320.2) | 94 | 105.4 (82.3–135.1) | |
| GMFRb | 4 | 1.62 (0.47–5.58) | 14 | 0.71 (0.54–0.94) | 97 | 2.15 (1.70–2.71) | 92 | 1.02 (0.86–1.22) | ||
| STMc | Number of patients vaccinated: ZVIN, 1326; placebo, 1349 | |||||||||
| Baseline | GMT | 21 | 177.1 (118.3–265.1) | 57 | 144.1 (114.5–181.3) | 1239 | 153.5 (146.1–161.4) | 1230 | 151.2 (143.5–159.3) | |
| ~28 days post–dose 4 | GMT | 14 | 307.9 (200.0–474.2) | 40 | 141.0 (108.9–182.5) | 943 | 293.8 (280.4–307.8) | 971 | 158.4 (149.7–167.6) | |
| GMFRb | 14 | 1.71 (1.34–2.18) | 39 | 1.00 (0.93–1.08) | 938 | 1.95 (1.87–2.02) | 960 | 1.03 (1.00–1.06) |
Abbreviations: auto-HSCT, autologous hematopoietic stem cell transplant; GMFR, geometric mean fold rise; gpELISA, glycoprotein enzyme-linked immunosorbent assay; HZ, herpes zoster; No., number of patients contributing to the immunogenicity analysis; STMc, solid tumor malignancies receiving chemotherapy; ZVIN, inactivated varicella zoster.
aResults for the gpELISA are reported as concentration of antibody in gpELISA units/mL.
bFrom day 1.