Table 1.
Clinical studies assessing antibody persistence following 4CMenB vaccination in infants.
| % with hSBA ≥ 4 (95% CI) |
hSBA GMT (95% CI) |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Study number, country (identifier*) |
Priming schedule | N | Months post last vaccination | fHbp | NadA | PorA | NHBA | fHbp | NadA | PorA | NHBA |
| Study 1, Europe, UK NCT01717638 Iro et al, 201722 |
2,4,6m, 12 or 18 or 24m booster | 58-60 | 24m | 24 | 97 | 12 | 74 | 2.41 | 69 | 1.38 | 9.08 |
| (14-37) | (88-100) | (5-23) | (61-85) | (1.83-3.19) | (50-96) | (1.11-1.72) | (5.97-14) | ||||
| 59-60 | 30m | 18 | 98 | 8 | 68 | 1.68 | 69 | 1.29 | 7.36 | ||
| (10-30) | (91-100) | (3-18) | (54-79) | (1.29-2.19) | (50-94) | (1.05-1.59) | (4.94-11) | ||||
| 65-67 | 36m | 12 | 93 | 9 | 54 | 1.75 | 36 | 1.25 | 6.14 | ||
| (5-22) | (83-98) | (2-18) | (41-66) | (1.36-2.25) | (27-48) | (1.03-1.52) | (4.19-8.99) | ||||
| 2,3,4m + 12 or 18 or 24m booster | 28 | 24m | 21 | 96 | 11 | 75 | 2.2 | 101 | 1.62 | 11 | |
| (8-41) | (82-100) | (2-28) | (55-89) | (1.37-3.53) | (57-177) | (1.21-2.16) | (5.9-21) | ||||
| 28 | 30m | 25 | 89 | 11 | 75 | 2.2 | 62 | 1.25 | 11 | ||
| (11-45) | (72-98) | (2-28) | (55-89) | (1.38-3.49) | (36-108) | (0.94-1.66) | (5.92-20) | ||||
| 40-42 | 36m | 12 | 90 | 10 | 68 | 1.51 | 52 | 1.32 | 9.61 | ||
| (4-26) | (77-97) | (3-23) | (51-81) | (1.04-2.18) | (34-81) | (1.05-1.65) | (5.81-16) | ||||
| Study 2, Europe NCT00847145, NCT01139021 Vesikari et al, 201323 and 201524 |
2,4,6, 12m+ MMRV at 12m or 13m | 305 | 12m | 62 | 97 | 17 | 36 | 6.5 | 81 | 1.9 | 3.4 |
| (5.6-7.5) | (71-94) | (1.7-2.2) | (2.9-3.9) | ||||||||
| Study 3, UK NCT01027351 Snape et al, 201325, McQuaid et al 201526 |
2,4,6, 12m | 15-17 | 28m | 65 | 76 | 41 | 67 | 5.3 | 28 | 2.8 | 5.3 |
| (38-86) | (50-93) | (18-67) | (38-88) | (3.3-8.8) | (9.4-83) | (1.4-5.6) | (2.3-12) | ||||
| 2,4,6, 12, 40m | 16 | 20m | 44 | 88 | 69 | 88 | 4.68 | 136 | 4.95 | 10 | |
| (20-70) | (62-98) | (41-89) | (62-98) | (2.3-9.52) | (51-365) | (3.54-6.92) | (5.67-19) | ||||
| Study 4, UK NCT01026974 Snape et al 201327, McQuaid et al 201428 |
6,8, 12m | 14 | 28m | 36 | 100 | 14 | 79 | 2.55 | 29 | 1.74 | 7.11 |
| (13-65) | (77-100) | (2-43) | (49-95) | (1.15-5.66) | (18-47) | (0.91-3.33) | (3.61-14) | ||||
| 6,8, 12, 40m | 11-12 | 20m | 67 | 100 | 17 | 45 | 4.69 | 119 | 1.63 | 5.51 | |
| (35-90) | (72-100) | (2-48) | (17-77) | (1.98-11) | (56-252) | (0.86-3.08) | (2.19-14) | ||||
| Study 5, Europe NCT01894919 Martinon-Torres et al, 201721 |
2.5, 3.5, 5, 11m | 127-140 | 24-36m | 51 | 84 | 45 | 36 | 4.17 | 44 | 3.48 | 2.77 |
| (42.8-60.0) | (77.2-89.9) | (36.6-53.6) | (27.9-45.2) | (3.40-5.13) | (32-60) | (2.78-4.36) | (2.06-3.71) | ||||
| 3.5, 5, 11m | 111-131 | 24-36m | 53 | 88 | 38 | 38 | 4.48 | 52 | 2.98 | 3.03 | |
| (43.8-61.5) | (80.9-92.9) | (29.8-47.1) | (28.8-47.5) | (3.60-5.57) | (37-72) | (2.35-3.78) | (2.20-4.16) | ||||
| 6, 8, 11m | 109-119 | 24-36m | 61 | 93 | 56 | 45 | 5.62 | 83 | 4.86 | 3.17 | |
| (52.0-70.1) | (87.2-97.1) | (46.9-65.4) | (35.4-54.8) | (4.48-7.04) | (58-117) | (3.80-6.22) | (2.30-4.38) | ||||
*identifier in www.clinicaltrials.gov, N = number of subjects in the persistence cohorts, CI = confidence interval, hSBA = serum bactericidal assay using human complement source, GMT = geometric mean antibody titer, m = months, UK = United Kingdom, fHbp = factor H binding protein, NadA = Neisseria adhesin A, PorA = porin A, NHBA = Neisserial Heparin Binding Antigen.