Table 3. hSBA GMTs against the three test strains in the individual study groups and as totals in those given 1, 2, or 3 doses at baseline (before dose 1), and 1 mo (from previous study11) and 18–24 mo after the last dose of 4CMenB, in the indicated schedules, and in vaccine-naïve subjects.
| One dose | Two doses | Three doses | Naive | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Schedule (mon)a | 0 | 6 | Total | 0,1 | 0,2 | 0,6 | Total | 0,1,2 | 0,1,6 | 0,2,6 | Total | - | |
| N | 95 | 51 | 146 | 102 | 106 | 49 | 257 | 153 | 53 | 57 | 263 | 151 | |
| Strain 44/76SL (fHbp) | |||||||||||||
| Baseline | 3.8 (2.8–5.1) |
4.3 (2.9–6.6) |
4.0 (3.1–5.1) |
2.7 (2.0–3.7) |
3.2 (2.4–4.3) |
2.8 (1.9–4.3) |
3.0 (2.5–3.6) |
3.9 (3.0–4.9) |
3.6 (2.4–5.3) |
2.8 (1.9–4.1) |
3.5 (2.9–4.3) |
||
| 1 Month after last dose | 47 (36–60) |
62 (44–86) |
52 (42–63) |
189 (149–241) |
227 (179–287) |
227 (161–320) |
211 (181–247) |
253 (208–309) |
316 (227–439) |
265 (192–365) |
268 (230–312) |
||
| 18–24 Months after last dose | 16 (11–23) |
19 (12–32) |
17 (12–23) |
29 (20–42) |
34 (24–49) |
27 (16–45) |
31 (24–39) |
42 (31–56) |
50 (30–83) |
44 (27–73) |
44 (35–55) |
4.5 (3.5–5.8) |
|
| Strain 5/99 (NadA) | |||||||||||||
| Baseline | 2.7 (2.0–3.4) |
2.7 (1.9–3.8) |
2.7 (2.2–3.3) |
2.2 (1.7–2.9) |
2.4 (1.8–3.0) |
2.3 (1.6–3.3) |
2.3 (2.0–2.7) |
2.6 (2.1–3.2) |
2.6 (1.8–3.6) |
1.7 (1.2–2.4) |
2.4 (2.0–2.8) |
||
| 1 Month after last dose | 63 (49–81) |
68 (49–94) |
65 (53–79) |
445 (352–562) |
727 (577–916) |
802 (574–1121) |
610 (523–710) |
605 (499–735) |
1181 (856–1630) |
1105 (808–1510) |
790 (679–920) |
||
| 18–24 Months after last dose | 7.1 (5.2–9.6) |
9.9 (6.6–15) |
8.0 (6.2–10) |
40 (30–54) |
43 (33–58) |
65 (43–98) |
46 (38–55) |
73 (57–92) |
121 (82–180) |
100 (68–146) |
86 (72–104) |
2.1 (1.7–2.6) |
|
| Strain NZ98/254 (NZOMV) | |||||||||||||
| Baseline | 2.7 (2.0–3.5) |
2.7 (1.8–3.9) |
2.7 (2.1–3.4) |
2.2 (1.6–2.8) |
2.6 (2.0–3.4) |
2.7 (1.8–3.9) |
2.4 (2.0–2.9) |
2.8* (2.2–3.4) |
3.7 (2.5–5.4) |
2.2 (1.6–2.8) |
2.8# (2.3–3.3) |
||
| 1 Month after last dose | 33 (25–43) |
43 (30–62) |
36 (29–45) |
78 (60–100) |
115 (89–148) |
154 (107–221) |
104 (88–123) |
129* (105–160) |
174 (123–248) |
170 (121–238) |
146# (124–172) |
||
| 18–24 Months after last dose | 8.7 (6.1–12) |
9.2 (5.7–15) |
8.9 (6.7–12) |
17 (12–24) |
19 (14–27) |
27 (17–43) |
20 (16–24) |
23 (18–31) |
42 (26–66) |
41 (26–64) |
30 (24–37) |
3.2 (2.5–4.1) |
|
a Schedule shows study months when 4CMenB administered. *n = 152; # n = 262.