Table 3.
Positive Predictive Value of Immune Response to Primary Strain for Immune Response to Additional Strain following MenB-FHbp Vaccination32
| % (95% CI)a [n/N]b | |||||
|---|---|---|---|---|---|
| FHbp variant | Adolescents | Young adults | |||
| Primary test strain | Additional test strain | 1 month after dose 2 | 1 month after dose 3 | 1 month after dose 2 | 1 month after dose 3 |
| A22 | A06 | 89.7 (81.27, 95.16) [78/87] | 96.0 (92.90, 97.97) [262/273] | 87.5 (77.59, 94.12) [63/72] | 94.0 (90.26, 96.59) [234/249] |
| A07 | 98.9 (93.83, 99.97) [87/88] | 96.3 (93.37, 98.23) [263/273] | 100.0 (95.20, 100.00) [75/75] | 99.2 (97.15, 99.90) [249/251] | |
| A12 | 72.7 (62.19, 81.68) [64/88] | 75.9 (70.37, 80.90) [205/270] | 67.6 (55.68, 78.00) [50/74] | 77.9 (72.24, 82.91) [194/249] | |
| A15 | 70.9 (60.14, 80.22) [61/86] | 89.7 (85.31, 93.18) [227/253] | 92.4 (84.20, 97.16) [73/79] | 93.9 (90.27, 96.47) [246/262] | |
| A19 | 87.8 (79.18, 93.74) [79/90] | 95.4 (92.11, 97.60) [249/261] | 97.5 (91.15, 99.69) [77/79] | 98.9 (96.76, 99.77) [265/268] | |
| A29 | 100.0 (95.98, 100.00) [90/90] | 99.6 (97.91, 99.99) [263/264] | 98.7 (93.15, 99.97) [78/79] | 100.0 (98.62, 100.00) [266/266] | |
| A56 | A06 | 84.3 (75.02, 91.12) [75/89] | 96.3 (93.29, 98.21) [260/270] | 83.3 (73.62, 90.58) [70/84] | 93.0 (89.23, 95.71) [251/270] |
| A07 | 94.4 (87.37, 98.15) [84/89] | 97.0 (94.22, 98.71) [261/269] | 98.9 (93.90, 99.97) [88/89] | 96.0 (92.88, 97.96) [261/272] | |
| A12 | 68.2 (57.39, 77.71) [60/88] | 75.6 (69.94, 80.61) [201/266] | 61.6 (50.51, 71.92) [53/86] | 72.2 (66.47, 77.48) [195/270] | |
| A15 | 64.4 (53.38, 74.35) [56/87] | 89.2 (84.68, 92.76) [223/250] | 84.6 (75.54, 91.33) [77/91] | 92.0 (88.10, 94.90) [252/274] | |
| A19 | 83.5 (74.27, 90.47) [76/91] | 93.8 (90.12, 96.41) [242/258] | 90.1 (82.05, 95.38) [82/91] | 96.4 (93.48, 98.26) [268/278] | |
| A29 | 100.0 (96.03, 100.00) [91/91] | 98.9 (96.68, 99.76) [258/261] | 97.8 (92.29, 99.73) [89/91] | 99.6 (98.01, 99.99) [276/277] | |
| B24 | B03 | 80.3 (68.16, 89.40) [49/61] | 97.1 (94.16, 98.83) [236/243] | 75.7 (63.99, 85.17) [53/70] | 89.9 (85.53, 93.28) [231/257] |
| B09 | 88.7 (78.11, 95.34) [55/62] | 92.1 (87.96, 95.19) [222/241] | 82.9 (71.97, 90.82) [58/70] | 80.5 (75.17, 85.20) [207/257] | |
| B15 | 100.0 (94.22, 100.00) [62/62] | 99.6 (97.75, 99.99) [244/245] | 100.0 (94.87, 100.00) [70/70] | 98.8 (96.67, 99.76) [257/260] | |
| B16 | 82.1 (69.60, 91.09) [46/56] | 86.4 (81.46, 90.46) [210/243] | 70.0 (57.87, 80.38) [49/70] | 81.3 (76.01, 85.90) [209/257] | |
| B44 | B03 | 78.9 (66.11, 88.62) [45/57] | 96.6 (93.40, 98.52) [227/235] | 88.9 (77.37, 95.81) [48/54] | 95.8 (92.38, 97.96) [227/237] |
| B09 | 88.3 (77.43, 95.18) [53/60] | 90.1 (85.50, 93.61) [209/232] | 96.4 (87.47, 99.56) [53/55] | 85.9 (80.77, 90.09) [201/234] | |
| B15 | 100.0 (94.04, 100.00) [60/60] | 99.2 (96.99, 99.90) [235/237] | 100.0 (93.51, 100.00) [55/55] | 98.3 (95.74, 99.54) [233/237] | |
| B16 | 84.9 (72.41, 93.25) [45/53] | 85.5 (80.37, 89.77) [201/235] | 79.6 (66.47, 89.37) [43/54] | 83.8 (78.40, 88.24) [196/234] | |
LLOQ = 1:8 for strains expressing variants A07, A15, A29, A56, B03, B09, B15, B16, B24, and B44; LLOQ = 1:16 for strains expressing variants A06, A12, A19, and A22
hSBA serum bactericidal assay using human complement, LLOQ lower limit of quantitation, MenB Neisseria meningitidis serogroup B
aExact 2-sided CI based on the observed proportion of subjects using the Clopper-Pearson method
bN = number of subjects with valid and determinate assay results for both the primary and additional strains with observed hSBA titer ≥ LLOQ for the primary strain at 1 month after vaccination 2 and at 1 month after vaccination 3; n = number of subjects with observed hSBA titer ≥ LLOQ for the given additional strain at 1 month after vaccination 2 and at 1 month after vaccination 3