Table 1.
N (%) or Median (IQR)a | ||||
---|---|---|---|---|
Immune Marker by Sample Type | Day | nOPV2-c1 (n = 15) | nOPV2-c2 (n = 15) | P Valueb |
Serum samples: PV type 2 serum neutralization titer | 0 | 56.9 (36.0–181) | 36.0 (22.6–90.5) | .10 |
28 | 1150 (576–1450) | 724 (362–1150) | .27 | |
Stool samplesc | ||||
Detectable PV type 2 stool neutralization, No. (%)d | 0 | 1 (6.7) | 0 (0) | .31 |
14 | 4 (26.7) | 4 (26.7) | >.99 | |
21 | 3 (20.0) | 2 (13.3) | .62 | |
28 | 5 (33.3) | 5 (33.3) | >.99 | |
All | 6 (40.0) | 7 (46.7) | .71 | |
PV type 2 stool neutralization titer | 0 | 2 (2–2) | 2 (2–2) | .32 |
14 | 2 (2–2.7) | 2 (2–2.5) | .96 | |
21 | 2 (2–2) | 2 (2–2) | .59 | |
28 | 2 (2–4) | 2 (2–7) | .79 | |
PV type 2 stool IgA MFI | 0 | 11.3 (2.0–14.1) | 12.0 (3.5–17.0) | .26 |
14 | 6.8 (3.2–22.3) | 7.4 (5.6–38.1) | .42 | |
21 | 10.8 (5.0–19.5) | 10.0 (2.5–46.5) | .72 | |
28 | 14.5 (2.0–29.5) | 12.3 (1.5–112) | .76 | |
PV type 1 stool IgA MFI | 0 | 6.3 (2.0–21.5) | 13.0 (5.9–22.5) | .25 |
14 | 8.0 (1.5–11.3) | 9.0 (4.4–24.0) | .42 | |
21 | 4.3 (0–8.0) | 3.5 (0–16.0) | .72 | |
28 | 6.3 (0–12.0) | 4.5 (0–28.0) | .68 | |
PV type 3 stool IgA MFI | 0 | 5.9 (3.5–31.0) | 13.8 (2.0–40.5) | .56 |
14 | 3.5 (0–15.0) | 8.3 (3.4–20.0) | .16 | |
21 | 0 (0–4.8) | 6.0 (0–18.5) | .15 | |
28 | 2.0 (0–14.5) | 1.0 (0–18.8) | .73 |
Abbreviations: IgA, immunoglobulin A; IQR, interquartile range; MFI, mean fluorescence intensity; nOPV2-c1and nOPV2-c2, novel type 2 oral poliovirus vaccine candidates; PV, poliovirus.
aData represent median (IQR) values unless otherwise specified.
b P values based on χ 2 or Mann-Whitney U tests.
cBecause stool samples were not available for all participants on all days, we described the aggregate of the measurements obtained from samples collected days on − 2 to 0 (before vaccination) for day 0, days 12–16 for day 14, days 19–23 for day 21, and days 26–30 for day 28. If ≥2 stool samples were collected within each window for a given participant, we calculated the geometric mean of the stool neutralization titer or IgA MFI.
dWe considered any poliovirus type 2–specific stool neutralization titer >2 to be detectable.