Table 3.
Saliva Snow Mountain Virus Immunoglobulin A (IgA) Over Total IgA Geometric Mean Fold Rise and Seroresponse (4-Fold Rise) Results by Time Point and Treatment Group, Modified Intention-to-Treat Population
| Study Day | Statistic | SMV Challenge Dose (GEC), mITT Population | ||||
|---|---|---|---|---|---|---|
| 1.2 × 104 (n = 9) | 1.2 × 106 (n = 9) | 1.2 × 107 S-Pos (n = 12) |
1.2 × 107 S-Neg (n = 8) |
Placebo (n = 6) | ||
| 2 | n; GMFRa (95% CI) | 9; 0.8 (.5–1.2) | 9; 1.0 (.8–1.3) | 12; 1.0 (.9–1.2) | 8; 1.2 (.7–1.8) | 6; 1.1 (.5–2.2) |
| 4-fold riseb (95% CI) | 0 (0–34) | 0 (0–34) | 0 (0–26) | 0 (0–37) | 0 (0–46) | |
| 3 | n; GMFRa (95% CI) | 9; 0.8 (.6–1.0) | 8; 1.0 (.8–1.3) | 12; 1.3 (1.0–1.6) | 8; 0.9 (.7–1.3) | 6; 0.6 (.3–1.2) |
| 4-fold riseb (95% CI) | 0 (0–34) | 0 (0–37) | 0 (0–26) | 0 (0–37) | 0 (0–46) | |
| 4 | n; GMFRa (95% CI) | 9; 0.8 (.5–1.2) | 7; 0.9 (.6–1.2) | 12; 0.9 (.7–1.2) | 8; 1.0 (.7–1.4) | 6; 1.0 (.6–1.8) |
| 4-fold riseb (95% CI) | 0 (0–34) | 0 (0–41) | 0 (0–26) | 0 (0–37) | 0 (0–46) | |
| 5 | n; GMFRa (95% CI) | 9; 0.9 (.6–1.3) | 7; 0.7 (.5–1.0) | 12; 1.0 (.7–1.2) | 8; 0.8 (.5–1.3) | 6; 0.9 (.4–2.0) |
| 4-fold riseb (95% CI) | 0 (0–34) | 0 (0–41) | 0 (0–26) | 0 (0–37) | 0 (0–46) | |
| 6 | n; GMFRa (95% CI) | 9; 0.9 (.6–1.3) | 7; 0.9 (.7–1.2) | 12; 1.2 (.8–1.7) | 8; 1.2 (.8–1.8) | 6; 1.0 (.6–1.8) |
| 4-fold riseb (95% CI) | 0 (0–34) | 0 (0–41) | 0 (0–26) | 0 (0–37) | 0 (0–46) | |
| 15 | n; GMFRa (95% CI) | 9; 0.6 (.4–.9) | 7; 1.7 (.8–3.7) | 12; 4.2 (2.3–7.9) | 8; 3.0 (1.4–6.3) | 6; 1.1 (.7–1.8) |
| 4-fold riseb (95% CI) | 0 (0–34) | 14 (0–58) | 42 (15–72) | 38 (9–76) | 0 (0–46) | |
| 30 | n; GMFRa (95% CI) | 9; 0.5 (.3–.9) | 7; 1.3 (.7–2.3) | 12; 2.7 (1.6–4.8) | 8; 2.1 (1.1–3.8) | 5; 1.4 (.6–3.4) |
| 4-fold riseb (95% CI) | 0 (0–34) | 14 (0–58) | 33 (10–65) | 25 (3–65) | 20 (1–72) | |
| 45 | n; GMFRa (95% CI) | 9; 0.8 (.5–1.2) | 7; 2.1 (1.2–3.8) | 10; 2.2 (1.2–4.2) | 7; 1.4 (.7–2.8) | 5; 1.3 (.6–2.8) |
| 4-fold riseb (95% CI) | 0 (0–34) | 14 (0–58) | 20 (3–56) | 14 (0–58) | 0 (0–52) | |
| Any time | n; GMFRa (95% CI) | 9; 1.3 (.9–1.7) | 9; 2.3 (1.5–3.5) | 12; 4.4 (2.4–8.0) | 8; 3.4 (1.9–6.2) | 6; 1.8 (1.0–3.2) |
| 4-fold riseb (95% CI) | 0 (0–34) | 11 (0–48) | 42 (15–72) | 38 (9–76) | 17 (0–64) | |
Abbreviations: CI, confidence interval; GEC, genome equivalent copies; GMFR, geometric mean fold rise; mITT, modified intention-to-treat; SMV, Snow Mountain virus; S-Neg, secretor-negative; S-Pos, secretor-positive.
GMFR in the ratio of SMV-specific immunoglobulin A (IgA) over total IgA compared to prechallenge (day 1). Any time represents the geometric mean of the maximum fold rise.
Four-fold rise represents the percentage of subjects with at least a 4-fold rise in the ratio of SMV-specific IgA over total IgA compared to prechallenge (day 1).