Table 4.
Group | Timing | N | Seropositivity rate (>18 mIU/mL), % (95% CI) | GMCs, % (95% CI) | N | Adjusted GMC fold increase over saline (95% CI) | P for the ratio over saline |
---|---|---|---|---|---|---|---|
3 doses gE/AS01B | Month 0 (Pre) | 30 | 100 (88.4-100) | 531.2 (402.6-700.8) | — | — | — |
Month 1 | 30 | 100 (88.4-100) | 1 489.7 (847.3-2 619.0) | 30 | 2.99 (1.73-5.16) | .0003 | |
Month 2 | 30 | 100 (88.4-100) | 11 963.0 (4 739.4-30 196.6) | 30 | 26.66 (9.97-71.29) | <.0001 | |
Month 3 | 28 | 100 (87.7-100) | 13 412.9 (4 967.1-36 219.7) | 28 | 26.87 (9.07-79.56) | <.0001 | |
Month 4 | 29 | 100 (88.1-100) | 29 192.9 (11 004.7-77 442.1) | 29 | 74.41 (25.74-215.09) | <.0001 | |
Month 15 | 27 | 100 (87.2-100) | 8 052.7 (3 333.4-19 453.7) | 27 | 28.70 (10.92-75.46) | <.0001 | |
3 doses gE/AS01E | Month 0 (Pre) | 28 | 96.4 (81.7-99.9) | 536.2 (304.0-945.7) | — | — | — |
Month 1 | 28 | 96.4 (81.7-99.9) | 1 288.1 (684.9-2 422.5) | 28 | 2.53 (1.6-23.94) | .0002 | |
Month 2 | 28 | 100 (87.7-100) | 11 628.8 (5 196.6-26 022.8) | 27 | 22.26 (9.03-54.91) | <.0001 | |
Month 3 | 27 | 100 (87.2-100) | 13 385.4 (5 506.5-32 537.7) | 26 | 20.51 (7.14-58.90) | <.0001 | |
Month 4 | 26 | 100 (86.8-100) | 22 503.0 (8 432.7-60 050.2) | 26 | 52.11 (17.36-156.41) | <.0001 | |
Month 15 | 22 | 100 (84.6-100) | 9 165.5 (3 796.0-22 130.1) | 22 | 21.98 (7.87-61.37) | <.0001 | |
2 doses gE/AS01B | Month 0 (Pre) | 30 | 100 (88.4-100) | 448.0 (289.7-692.8) | — | — | — |
Month 1 | 30 | 100 (88.4-100) | 376.1 (239.7-590.1) | 29 | 0.96 (0.80-1.14) | .6240 | |
Month 2 | 29 | 100 (88.1-100) | 1 047.8 (564.8-1 943.9) | 28 | 2.94 (1.78-4.85) | <.0001 | |
Month 3 | 28 | 100 (87.7-100) | 972.6 (520.6-1 817.2) | 27 | 2.31 (1.20-4.42) | .0126 | |
Month 4 | 27 | 100 (87.2-100) | 11 064.6 (4 361.2-28 071.8) | 26 | 42.20 (16.07-110.82) | <.0001 | |
Month 15 | 23 | 100 (85.2-100) | 2 968.0 (1 184.7-7 436.1) | 22 | 8.81 (3.41-22.80) | <.0001 | |
3 doses saline | Month 0 (Pre) | 30 | 100 (88.4-100) | 659.9 (470.5-925.4) | — | — | — |
Month 1 | 29 | 100 (88.1-100) | 619.3 (424.2-904.0) | 29 | — | — | |
Month 2 | 28 | 100 (87.7-100) | 520.2 (349.3-774.8) | 28 | — | — | |
Month 3 | 29 | 100 (88.1-100) | 585.2 (310.0-1 104.9) | 29 | — | — | |
Month 4 | 26 | 100 (86.8-100) | 406.0 (244.2-674.9) | 26 | — | — | |
Month 15 | 21 | 100 (83.9-100) | 362.3 (170.7-768.7) | 21 | — | — |
Analysis was done on the total vaccinated cohort at months 0 to 4 and on the total vaccinated cohort excluding 4 HZ cases at month 15.
gE/AS01B, glycoprotein E/liposome-based adjuvant (50 µg MPL, 50 µg QS21); gE/AS01E, glycoprotein E/liposome-based adjuvant (25 µg MPL, 25 µg QS21); GMC, geometric mean concentration.