TABLE 1.
Company and target population | Trial details (age of participants, no. of participants, ClinicalTrials.gov identifier) | Strain name | Neisseria.org ID | Groupb | Sequence IDc | % Homology to fHBP vaccine antigend | % of responders after dosee: |
|
---|---|---|---|---|---|---|---|---|
2 | 3 | |||||||
Novartis | ||||||||
Infants | 2 mo, 147, NCT00381615 | H44/76 | 1 | B, 1 | B24, 1.1 | 100 | 95 | 87f |
M01240355 | 31 | A, 3 | A47, 3.31 | 65.4 | 0 | 0 | ||
M01240101 | 15 | B, 1 | B44, 1.15 | 85.9 | 28 | 47 | ||
6–8 mo, 60, NCT00433914 | H44/76-SL | 1 | B, 1 | B24, 1.1 | 100 | 100 | 100g | |
M01240101 | 15 | B, 1 | B44, 1.15 | 85.9 | 67 | 70 | ||
M01240355 | 31 | A, 3 | A47, 3.31 | 65.4 | 7 | 17 | ||
2 mo, 1885, NCT00721396 | 44/76-SL | 1 | B, 1 | B24, 1.1 | 100 | NDh | 99i | |
Adolescents | 11–17 yr, 1631, NCT00661713 | 44/76 | 1 | B, 1 | B24, 1.1 | 100 | 99 | 100j |
1000 | 25 | A, 2 | A15, 2.25 | 68.1 | 85 | 86k | ||
44/76 | 1 | B, 1 | B24, 1.1 | 100 | 100 | 100 | ||
95N477 | 22 | A, 2 | A10, 2.22 | 69.3 | 7 | 7 | ||
Adults | 18–40 yr, 70 | M01240013 | 19 | A, 2 | A22, 2.19 | 72.4 | 81 | 79 |
M1390 | 14 | B, 1 | B03, 1.14 | 91.8 | 96 | 96 | ||
M3812 | 12 | B, 1 | B06, 1.12 | 93.7 | 82 | 79 | ||
M4105 | 4 | B, 1 | B16, 1.4 | 96.1 | 100 | 100 | ||
M4458 | 25 | A, 2 | A15, 2.25 | 68.1 | 79 | 70 | ||
M6190 | 6 | B, 1 | B10, 1.6 | 94.5 | 39 | 43 | ||
18–50 yr, 54, NCT00560313 | 44/76-SL | 1 | B, 1 | B24, 1.1 | 100 | 100 | 97l | |
Pfizer | ||||||||
Toddlers | 18–36 mo, 99, NCT00387569 | PMB1745 | 45 | A, 3 | A05, 3.45 | 100 | 59 | 83m |
PMB17 | 87 | B, 1 | B02, 1.87 | 92 | 38 | 89 | ||
PMB663 | 19 | A | A22, 2.19 | 88.9 | 0 | 44 | ||
PMB265 | 13 | B, 1 | B09, 1.13 | 88.1 | 0 | 11 | ||
PMB3556 | 1 | B, 1 | B24, 1.1 | 86.2 | 7 | 20 | ||
PMB1168 | 45 | A, 3 | A05, 3.45 | 100 | ND | 100 | ||
PMB147 | 15 | B, 1 | B44, 1.15 | 91.6 | ND | 94 | ||
PMB1256 | 14 | B, 1 | B03, 1.14 | 90.8 | ND | 82 | ||
PMB1321 | 19 | A | A22, 2.19 | 88.9 | ND | 100 | ||
Children and adolescents | 8–14 yr, 127, NCT00387725 | PMB1745 | 45 | A, 3 | A05, 3.45 | 100 | 86 | 91n |
PMB663 | 19 | A | A22, 2.19 | 88.9 | 53 | 59 | ||
PMB3556 | 1 | B, 1 | B24, 1.1 | 86.2 | 29 | 60 | ||
PMB17 | 87 | B, 1 | B02, 1.87 | 92 | 69 | 98 | ||
PMB265 | 13 | B, 1 | B09, 1.13 | 88.1 | 14 | 47 | ||
Adolescents | 11–18 yr, 539, NCT00808028 | PMB3302 | 180 | A, 3 | A04, 3.180 | 96.6 | 97 | 98o |
PMB1256 | 14 | B, 1 | B03, 1.14 | 90.8 | 30 | 68 | ||
PMB2001 | 187 | A, 3 | A56, 3.187 | 98.1 | 97 | 96 | ||
PMB2707 | 15 | B, 1 | B44, 1.15 | 91.6 | 70 | 87 | ||
PMB1321 | 19 | A, 2 | A22, 2.19 | 88.9 | ND | 88 | ||
PMB2948 | 1 | B, 1 | B24, 1.1 | 86.2 | ND | 84 | ||
PMB1745 | 45 | A, 3 | A05, 3.45 | 100 | 95 | 97 | ||
PMB17 | 87 | B, 1 | B02, 1.87 | 99 | 79 | 90 | ||
Young adults | 18–25 yr, 103, NCT00297687 | PMB1745 | 45 | A, 3 | A05, 3.45 | 100 | 91 | 100p |
PMB17 | 87 | B, 1 | B02, 1.87 | 99 | 82 | 88 | ||
PMB267 | 49 | A, 2 | A17, 2.49 | 88.1 | 100 | 100 | ||
PMB265 | 13 | B, 1 | B09, 1.13 | 88.1 | 97 | 96 | ||
PMB663 | 19 | A | A22, 2.19 | 88.9 | 64 | 100 | ||
PMB3556 | 45 | A, 3 | A05, 3.45 | 100 | 81 | 100 | ||
Adults | 18–40 yr, 60, NCT00780806 | PMB1745 | 45 | A, 3 | A05, 3.45 | 100 | 75 | 94q |
PMB17 | 87 | B, 1 | B02, 1.87 | 99 | 70 | 94 | ||
PMB1321 | 19 | A, 2 | A22, 2.19 | 88.9 | 75 | 94 | ||
PMB2707 | 15 | B, 1 | B44, 1.15 | 91.6 | 83 | 94 | ||
PMB2948 | 1 | B, 1 | B24, 1.1 | 86.2 | 72 | 81 |
Strains that express the 4CMenB vaccine homologous PorA or NadA protein are not included in this table, which focuses on SBA responses to fHBP.
Pfizer subfamily, Novartis variant.
Pfizer variant number, Novartis subvariant number.
B24 (1.1) for Novartis, A05 (3.45) and B01 (1.55) for Pfizer.
Percentage of responders at 1 month after the indicated dose.
Percentage of participants with hSBA titers of ≥4 (77).
ND, not determined.
Percentage of participants with hSBA titers of ≥1:4 (83).
Percentage of participants with hSBA titers of ≥1:5 (78).
Percentage of participants with hSBA titers of ≥4 (82).
Percentage of participants with hSBA titers of ≥4 (127).
Percentage of participants with hSBA titers of ≥4 (79).
Percentage of participants with ≥4-fold rise in hSBA titer (128).
Percentage of participants with hSBA titers of ≥1:4 (129).
Percentage of participants with hSBA titers equal to or greater than the limit of quantitation (LOQ) (80).
Percentage of participants with hSBA titers of ≥1:4 (81).
Percentage of participants with hSBA titers of ≥1:4 (130).