Table 3.
Immunogenicity of NDV-3A – Baseline and Day 14 IgG and IgA1 GMT, NDV-3A vs. Placebo; Day 14 GMFR, NDV-3A vs. Placebo.
| Time Point and Immunology Endpoint | NDV-3A, n = 27 | Placebo, n = 14 |
|---|---|---|
| Visit 1 (pre-vaccination) | ||
| GMT (95% CI) | ||
| Als3-IgG | 374 (221–633) | 682 (251–1,858) |
| Als3-IgA1 | 3,892 (1,852–8,178) | 19,724 (7,074–54,998) |
| Visit 3 (Day 14) | ||
| GMT (95% CI) | ||
| Als3-IgG | 63,397 (33,686–119,313) | 666 (213–2,084) |
| Als3-IgA1 | 110,541 (60,541–201,833) | 17,044 (5,358–54,223) |
| GMFR (95% CI)a | ||
| Als3-IgG | 169.7 (80.5–357.7) | 1.0 (0.7–1.3) |
| Als3-IgA1 | 28.4 (12.0–67.5) | 0.9 (0.6–1.3) |
| Seroconversion %, ≥4-Fold Rise (95% CI)b Als3-IgG | 100 (87.2–100) | 7.1 (0.2–33.9) |
| Visit 4 (Day 28) | ||
| Als3-IgG GMT (95% CI) | 37,601 (19,423–72,791) | 700 (238–2,060) |
| Als3-IgG GMFR (95% CI)a | 100.6 (44.7–226.4) | 1.0 (0.8–1.4) |
| Als3-IgG Seroconversion %, ≥4-Fold Rise (95% CI)b | 96.3 (81.0–99.9) | 0 (0–23.2) |
| Visit 5 (Day 56) | ||
| Als3-IgG GMT (95% CI) | 28,184 (15,537–51,125) | 766 (256–2,292) |
| Als3-IgG GMFR (95% CI)a | 75.4 (36.1–157.4) | 1.1 (0.7–1.8) |
| Als3-IgG Seroconversion %, ≥4-Fold Rise (95% CI)b | 92.6 (75.7–99.1) | 7.1 (0.2–33.9) |
| Visit 6 (Day 90–115) | ||
| Als3-IgG GMT (95% CI) | 11,774 (4,890–28,349) | 402 (122–1,325) |
| Als3IgG GMFR (95% CI)a | 31.5 (11.1–89.8) | 0.6 (0.2–2.0) |
| Als3IgG Seroconversion %, ≥4-Fold Rise (95% CI)b | 88.9 (70.8–97.6) | 7.1 (0.2–33.9) |
| Peak Titer c | ||
| Als3-IgG GMT (95% CI) | 65,051 (34,474–122,746) | 882 (290–2,685) |
| Als3-IgG GMFR (95% CI)a | 174.1 (82.5–367.2) | 1.3 (0.8–2.1) |
| Als3-IgG Seroconversion %, ≥4-Fold Rise (95% CI)b | 100 (87.2–100) | 14.3 (1.8–42.8) |
CI – confidence interval; GMFR – geometric mean fold rise; GMT – geometric mean titer.
a
GMFR represents geometric mean fold rise in antibody compared to the pre-vaccination study Visit 1.
b
Seroconversion % represents the percentage of subjects with at least a 4-Fold Rise in antibody titer compared to pre-vaccination (Visit 1).
c
Peak titer summarizes the maximum post-baseline result for each subject.