Table 3.
Percentages of participants with hSBA ≥5 and geometric mean hSBA titers (95% CI) against serogroup B strains at different timepoints – FAS Immunogenicity Kinetics.
| % of participants with hSBA ≥5 (95% CI) |
GMT (95% CI) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Group III | Group VI |
Group VII |
Group III | Group VI | Group VII | |||||
| a | b | a | b | |||||||
| Strains (antigens) | Timepoint | N=33 | N=23 | N=23 | N=26 | N=24 | N=33 | N=46 | N=50 | |
| H44/76 (fHbp) | Booster/Dose 1 | Pre | 27 (13.3–45.5) | 9 (1.1–28.0) | 0 (0–14.8) | 12 (2.4–30.2) | 8 (1.0–27.0) | 2.33 (1.57–3.45) | 1.21 (1.03–1.42) | 1.44 (1.14–1.80) |
| D3 | 21 (9.0–38.9) | 4 (0.11–21.9) | — | — | — | 2.58 (1.78–3.75) | 1.38 (1.05–1.81)* | — | ||
| D7 | 94 (79.8–99.3) | — | 14 (2.9–34.9) | — | — | 64 (38–109) | 1.84 (1.18–2.89)* | — | ||
| D30 | 97 (84.2–99.92) | 52 (30.6–73.2) | 52 (30.6–73.2) | 73 (52.2–88.4) | 46 (25.6–67.2) | 98 (57–170) | 5.78 (3.59–9.31) | 7.27 (4.53–12) | ||
| Dose 2 | D3 | — | — | — | 69 (48.2–85.7) | — | — | — | 8.91 (4.62–17)** | |
| D7 | — | — | — | — | 96 (78.9–99.89) | — | — | 35 (20–60)*** | ||
| D30 | — | 78 (56.3–92.5) | 91 (72–98.9 | 96 (79.6–99.9) | 79 (57.8–92.9) | — | 16 (10–24) | 32 (21–49) | ||
| M14459 (fHbp) | Booster/Dose 1 | Pre | 18 (7.0–35.5) | 9 (1.1–28.0) | 0 (0–14.8) | 8 (0.9–25.1) | 8 (1.0–27.0) | 2.04 (1.46–2.83) | 1.37 (1.12–1.69) | 1.48 (1.18–1.85) |
| D3 | 21 (9.0–38.9) | 4 (0.1–21.9) | — | — | — | 1.99 (1.44–2.75) | 1.22 (0.96–1.54)* | — | ||
| D7 | 79 (61.1–91.0) | — | 14 (2.9–34.9) | — | — | 17 (9.31–30) | 1.52 (1.05–2.20)* | — | ||
| D30 | 85 (68.1–94.9) | 35 (16.4–57.3) | 27 (10.7–50.2) | 46 (26.6–66.6) | 33 (15.6–55.3) | 24 (14–42) | 2.83 (1.88–4.24) | 4.02 (2.67–6.06) | ||
| Dose 2 | D3 | — | — | — | 42 (23.4–63.1) | — | — | — | 5.06 (2.96–8.66)** | |
| D7 | — | — | — | — | 71 (48.9–87.4) | — | — | 9.16 (5.35–16)*** | ||
| D30 | — | 43 (23.2–65.5) | 48 (26.8–69.4) | 80 (59.3–93.2) | 54 (32.8–74.4) | — | 3.50 (2.33–5.26) | 9.78 (6.42–15) | ||
| 5/99 (NadA) | Booster/Dose 1 | Pre | 70 (51.3–84.4) | 22 (7.5–43.7) | 13 (2.8–33.6) | 19 (6.6–39.4) | 13 (2.7–32.4) | 13 (7.29–22) | 1.78 (1.36–2.34) | 1.90 (1.42–2.53) |
| D3 | 79 (61.1–91.0) | 9 (1.1–28.0) | — | — | — | 17 (9.56–31) | 1.99 (1.36–2.92)* | — | ||
| D7 | 100 (89.4–100) | — | 9 (1.1–29.2) | — | — | 1768 (1204–2596) | 1.97 (0.88–4.42)* | — | ||
| D30 | 100 (89.4–100) | 78 (56.3–92.5) | 78 (56.3–92.5) | 85 (65.1–95.6) | 79 (57.8–92.9) | 1426 (940–2164) | 19 (11–34) | 25 (15–42) | ||
| Dose 2 | D3 | — | — | — | 85 (65.1–95.6) | — | — | — | 40 (18–90)*** | |
| D7 | — | — | — | — | 100 (85.8–100) | — | — | 432 (273–683)*** | ||
| D30 | — | 100 (85.2–100) | 100 (85.2–100) | 100 (86.3–100) | 100 (85.8–100) | — | 110 (76–159) | 256 (194–338) | ||
| M01-0240364 (NadA) | Booster/Dose 1 | Pre | 13 (3.6–29.8) | 9 (1.1–29.2) | 0 (0–15.4) | 4 (0.1–19.6) | 4 (0.1–21.1) | 2.26 (1.26–4.08) | 1.14 (0.97–1.35) | 1.23 (1.02–1.47) |
| D3 | 17 (5.6–34.7) | 4 (0.1–21.9) | — | — | — | 2.50 (1.25–5.02) | 1.36 (1.02–1.82)* | — | ||
| D7 | 93 (77.2–99.2) | — | 10 (1.2–30.4) | — | — | 525 (257–1074) | 1.65 (0.79–3.43)* | — | ||
| D30 | 97 (82.8–99.9) | 29 (11.3–52.2) | 22 (7.5–43.7) | 33 (15.6–55.3) | 24 (8.2–47.2) | 601 (339–1064) | 3.05 (1.77–5.26) | 3.11 (1.76–5.51) | ||
| Dose 2 | D3 | — | — | — | 40 (21.1–61.3) | — | — | 5.13 (2.17-12)** | ||
| D7 | — | — | — | — | 82 (59.7–94.8) | — | — | 75 (29–199)*** | ||
| D30 | — | 65 (42.7–83.6) | 65 (42.7–83.6) | 70 (47.1–86.8) | 71 (48.9–87.4) | — | 16 (8.77–31) | 21 (11–38) | ||
| 96217 (NadA) | Booster/Dose 1 | Pre | 61 (42.1–77.1) | 22 (7.5–43.7) | 22 (7.5–43.7) | 42 (23.4–63.1) | 29 (12.6–51.1) | 16 (8.89–28) | 2.35 (1.51–3.64) | 4.08 (2.52–6.62) |
| D3 | 70 (51.3–84.4) | 39 (19.7–61.5) | — | — | — | 1211 (823–1781) | 3.77 (1.81–7.89)* | — | ||
| D7 | 100 (89.4–100) | — | 36 (17.2–59.3) | — | — | 970 (687–1369) | 4.20 (1.75–10)* | — | ||
| D30 | 100 (89.4–100) | 57 (34.5–76.8) | 74 (51.6–89.8) | 73(52.2–88.4) | 75(53.3–90.2) | — | 15 (7.83–27) | 19 (11–33) | ||
| Dose2 | D3 | — | — | — | 77 (56.4–91.0) | — | — | — | 29 (13–67)** | |
| D7 | — | — | — | — | 100 (85.8–100) | — | — | 309 (203–469)*** | ||
| D30 | — | 100 (85.2–100) | 100 (85.2–100) | 100 (86.3–100) | 100 (85.8–100) | — | 63 (38–103) | 169 (129–222) | ||
| M10713 (NHBA) | Booster/Dose 1 | Pre | 48 (30.8–66.5) | 48 (26.8–69.4) | 17 (5.0–38.8) | 38 (20.2–59.4) | 38 (18.8–59.4) | 3.66 (2.38–5.62) | 2.56 (1.74–3.75 ) | 3.10 (2.16–4.45) |
| D3 | 56 (37.7–73.6) | 39 (19.7–61.5) | — | — | — | 4.16 (2.70–6.41) | 3.73 (2.10-6.65)* | — | ||
| D7 | 79 (61.1–91.0) | — | 32 (13.9–54.9) | — | — | 15 (9.26–23) | 2.03 (1.30–3.17)* | — | ||
| D30 | 85 (68.1–94.9) | 70 (47.1–86.8) | 35 (16.4–57.3) | 62 (40.6–79.8) | 54 (32.8–74.4) | 20 (13–31) | 5.51 (3.45–8.79) | 7.70 (5.04–12) | ||
| Dose 2 | D3 | — | — | — | 57 (34.5–76.8) | — | — | — | 6.70 (3.37–13)*** | |
| D7 | — | — | — | — | 67 (44.7–84.4) | — | — | 8.94 (4.91–16)*** | ||
| D30 | — | 65 (42.7–83.6) | 43 (23.2–65.5) | 68 (46.5–85.1) | 63 (40.6–81.2) | — | 2.70 (1.94–3.77) | 8.73 (5.80–13) | ||
| NZ98/254 (PorA) | Booster/Dose 1 | Pre | 15 (5.1–31.9) | 4 (0.11–21.9) | 0 (0–14.8) | 8 (0.9–25.1) | 4 (0.11–21.1) | 1.81 (1.30–2.51) | 1.35 (1.15–1.59) | 1.45 (1.18–1.77) |
| D3 | 12 (3.4–28.2) | 13 (2.8–33.6) | — | — | — | 1.90 (1.41–2.57) | 1.89 (1.38–2.59)** | — | ||
| D7 | 67 (48.2–82) | — | 9 (1.1–29.2) | — | — | 8.19 (5.45–12) | 1.52 (1.12–2.06)* | — | ||
| D30 | 82 (64.5–93.0) | 48 (26.8–69.4) | 26 (10.2–48.4) | 58 (36.9–76.6) | 46 (25.6–67.2) | 13 (8.50–18) | 3.57 (2.37–5.38) | 5.75 (3.95–8.37) | ||
| Dose 2 | D3 | — | — | — | 50 (29.9–70.1) | — | — | — | 6.93 (4.02–12)** | |
| D7 | — | — | — | — | 75 (53.3–90.2) | — | — | 7.92 (5.03–12)*** | ||
| D30 | — | 52 (30.6–73.2) | 39 (19.7–61.5) | 72 (50.6–87.9) | 50 (29.1–70.9) | 9.15 (4.78–18) | 4.61 (3.22–6.60) | 7.50 (5.12–11) | ||
hSBA, human serum bactericidal assay; CI, confidence interval; FAS, full analysis set; N, number of participants in a group; GMT, geometric mean titer; fHbp, factor H binding protein; NadA, Neisseria adhesin A; NHBA, Neisserial heparin-binding antigen; PorA, porin A. Pre, pre-vaccination; D3, 3 days after vaccine booster/dose 1 or 2; D7, 7 days after vaccine booster/dose 1 or 2; D30, 30 days after vaccine booster/dose 1 or 2;
*
n=23,
**
n=26,
***
n=24, maximum number of participants with results at day 3 and day 7 in subgroups VIa, VIb, VIIa and VIIb. A “–“ is placed in the cells where no analysis was planned for those specific time points.