Table 4.
Pan-Immunoglobulin (Pan-Ig), Immunoglobulin A (IgA), and Histo-Blood Group Antigen (HBGA)–Blocking Antibody (Ab) Responses Against Norovirus GI.1 and GII.4 at the Indicated Time Points in the Per-Protocol Set, by Study Group
| Pan-Ig Ab, Titer (95% CI) |
IgA Ab, Titer (95% CI) |
HBGA-Blocking Ab, Titer (95% CI) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Genotype, Time, Variable | Placebo (n = 151) | 15/50 Vaccine Group (n=140) | 50/50 Vaccine Group (n = 151) | Placebo (n = 151) | 15/50 Vaccine Group (n=140) | 50/50 Vaccine Group (n = 151) | Placebo (n = 151) | 15/50 Vaccine Group (n=140) | 50/50 Vaccine Group (n = 151) |
| GI.1 | |||||||||
| Baseline | |||||||||
| GMT | 287 (213–386) | 346 (253–473) | 335 (248–452) | 21 (17–26) | 21 (17–27) | 25 (19–32) | 19 (17–21) | 19 (17–21) | 20 (18–23) |
| Day 3 | |||||||||
| GMT | 284 (195–415) | 338 (244–467) | 340 (243–475) | 18 (14–24) | 21 (16–28) | 25 (18–34) | 18 (16–20) | 19 (17–22) | 19 (17–22) |
| SR, %a | 3.5 (1.0–8.7) | 1.8 (.2–6.4) | 1.8 (.2–6.4) | 0.9 (0–4.8) | 1.8 (0.2–6.4) | 0 (0–3.3) | 0.9 (0–4.8) | 0 (0–3.3) | 0 (0–3.3) |
| Day 5 | |||||||||
| GMT | 318 (234–433) | 622 (454–852) | 784 (588–1045) | 20 (16–26) | 49 (36–66) | 76 (56–104) | 19 (17–21) | 26 (22–31) | 29 (24–52) |
| SR, %a | 4.7 (1.9–9.5) | 19.4 (13.1–27.1) | 27.0 (20.1–34.9) | 0.7 (0–3.7) | 25.4 (18.3–33.6) | 34.5 (26.8–42.7) | 0.7 (0–3.7) | 8.2 (4.2–14.2) | 11.0 (6.4–17.2) |
| Day 7–10 | |||||||||
| GMT | 284 (208–386) | 12 893 (9912–16 770) | 23 150 (17 939–29 875) | 20 (16–26) | 1852 (1319–2601) | 3783 (2755–5196) | 19 (17–22) | 209 (162–270) | 332 (253–436) |
| SR, %a | 4.1 (1.5–8.6) | 84.6 (77.4–90.2) | 93.2 (87.8–96.7) | 0.7 (0–3.7) | 93.4 (87.8–96.9) | 95.2 (90.4–98.1) | 0 (0–2.5) | 78.0 (70.0–84.8) | 81.1 (73.7–87.2) |
| GMFR | 1.0 (.86–1.13) | 38.0 (27.4–52.6) | 69.8 (51.9–94.0) | 1.0 (.91–1.03) | 89.1 (65.7–121) | 148 (109–202) | 1.0 (1.00–1.06) | 10.7 (8.29–13.7) | 16.4 (12.5–21.5) |
| Day 28 | |||||||||
| GMT | 367 (273–493) | 13 023 (10 616–15 977) | 18 712 (15 070–23 233) | 21 (17–27) | 760 (551–1047) | 1363 (1055–1760) | 21 (18–24) | 172 (137–216) | 210 (168–261) |
| SR, %a | 8.6 (4.7–14.3) | 91.4 (85.5–95.5) | 90.1 (84.1–94.3) | 3.3 (1.1–7.6) | 92.1 (86.4–96.0) | 95.4 (90.7–98.1) | 3.3 (1.1–7.6) | 74.3 (66.2–81.3) | 80.8 (73.6–86.8) |
| GMFR | 1.3 (1.03–1.59) | 37.6 (27.8–50.9) | 55.9 (42.0–74.4) | 1.0 (.89–1.19) | 36.0 (27.3–47.5) | 55.6 (43.7–70.7) | 1.1 (1.02–1.21) | 8.9 (7.19–11.1) | 10.5 (8.53–12.8) |
| GII.4 | |||||||||
| Baseline | |||||||||
| GMT | 880 (660–1172) | 1055 (811–1373) | 1164 (921–1471) | 75 (57–100) | 92 (70–120) | 98 (76–125) | 77 (61–98) | 84 (67–107) | 87 (69–108) |
| Day 3 | |||||||||
| GMT | 792 (565–1109) | 1001 (748–1341) | 1197 (889–1612) | 64 (46–89) | 100 (75–135) | 92 (68–123) | 64 (49–83) | 79 (60–103) | 89 (68–115) |
| SR, %a | 1.8 (.2–6.2) | 0.9 (0–4.9) | 3.6 (1.0–9.0) | 0 (0–3.2) | 2.7 (.6–7.7) | 0 (0–3.3) | 0.9 (0–4.8) | 0 (0–3.3) | 0.9 (0–5.0) |
| Day 5 | |||||||||
| GMT | 894 (668–1195) | 1628 (1276–2076) | 1637 (1314–2039) | 76 (57–102) | 157 (119–207) | 154 (121–196) | 77 (60–98) | 130 (102–167) | 123 (98–155) |
| SR, %a | 2.0 (0.4–5.8) | 11.2 (6.4–17.8) | 5.4 (2.4–10.4) | 0.7 (0–3.7) | 12.7 (7.6–19.5) | 7.4 (3.9–12.9) | 0.7 (0–3.7) | 11.9 (7.0–18.7) | 8.1 (4.3–13.7) |
| Day 7–10 | |||||||||
| GMT | 875 (656–1167) | 13 819 (11 677–16 353) | 11 713 (9690–14 158) | 71 (54–94) | 1976 (1537–2541) | 1591 (1252–2020) | 75 (59–96) | 1234 (987–1541) | 973 (787–1204) |
| SR, %a | 1.4 (.2–4.8) | 76.5 (68.4–83.3) | 74.0 (66.1–80.9) | 0 (0–2.5) | 81.6 (74.1–87.7) | 80.8 (73.5–86.9) | 0.7 (0–3.7) | 75.0 (66.9–82.0) | 72.6 (64.6–79.7) |
| GMFR | 1.0 (.94–1.06) | 13.6 (10.4–17.9) | 10.0 (7.89–12.7) | 1.0 (.91–1.01) | 22.2 (16.7–29.4) | 16.0 (12.3–20.9) | 1.0 (.93–1.04) | 15.1 (11.4–20.0) | 11.3 (8.87–14.5) |
| Day 28 | |||||||||
| GMT | 956 (736–1241) | 11 276 (9757–13 030) | 8668 (7330–10 250) | 72 (54–96) | 816 (654–1017) | 642 (523–787) | 80 (63–101) | 804 (658–984) | 631 (528–755) |
| SR, %a | 4.6 (1.9–9.3) | 75.0 (67.0–81.9) | 69.5 (61.5–76.8) | 1.3 (0.2–4.7) | 70.0 (61.7–77.4) | 60.9 (52.7–68.8) | 2.6 (0.7–6.6) | 71.2 (62.9–78.6) | 68.2 (60.1–75.5) |
| GMFR | 1.1 (0.97–1.22) | 10.7 (8.36–13.7) | 7.4 (6.10–9.09) | 1.0 (0.87–1.06) | 8.9 (6.92–11.4) | 6.6 (5.46–7.87) | 1.0 (0.95–1.14) | 9.7 (7.65–12.2) | 7.3 (6.05–8.82) |
Abbreviations: CI, confidence interval; GMFR, geometric mean fold rise in antibody titer; GMT, geometric mean antibody titer.
a Seroresponse rates (SRs) denote the percentage showing a ≥4-fold increase in titer over baseline. The 95% confidence CIs are calculated on the basis of the Clopper-Pearson method.