Frequency of CD4(2+) T cells after induction with gE and fold increase over saline
| . | . | . | Descriptive statistics . | . | Adjusted geometric mean frequency CD4(2+) . | Adjusted fold increase over saline . | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Group . | Timing . | N . | Q1 . | Median . | Q3 . | N . | Value . | 95% CI . | Value . | 95% CI . | P . |
| 3 doses gE/AS01B | Month 0 (Pre) | 28 | 121.9 | 197.8 | 324.5 | — | — | — | — | — | — |
| Month 1 | 30 | 225.5 | 626.3 | 981.9 | 28 | 588.70 | 434.77-797.13 | 2.75 | 1.80-4.20 | <.0001 | |
| Month 2 | 30 | 2717.6 | 5705.5 | 9 430.9 | 27 | 5131.29 | 3 461.04-7 607.57 | 20.70 | 11.94-35.91 | <.0001 | |
| Month 3 | 28 | 1750.8 | 4377.1 | 10 561.5 | 26 | 4233.37 | 2 977.64-6 018.66 | 16.65 | 10.17-27.25 | <.0001 | |
| Month 4 | 28 | 3888.7 | 7934.2 | 14 416.3 | 25 | 7540.57 | 4 960.60-11 462.36 | 32.31 | 17.78-58.71 | <.0001 | |
| Month 15 | 26 | 2308.8 | 4772.2 | 10 038.1 | 25 | 4104.59 | 2 758.10-6 108.44 | 15.15 | 8.33-27.54 | <.0001 | |
| 3 doses gE/AS01E | Month 0 (Pre) | 27 | 117.1 | 253.6 | 535.7 | — | — | — | — | — | — |
| Month 1 | 29 | 230.2 | 584.8 | 1 268.9 | 27 | 690.55 | 462.24-1 031.63 | 2.65 | 1.58-4.44 | .0004 | |
| Month 2 | 28 | 1829.5 | 3085.5 | 12 615.0 | 24 | 3409.24 | 2 067.87-5 620.73 | 11.54 | 6.01-22.14 | <.0001 | |
| Month 3 | 27 | 1608.6 | 3656.9 | 11 121.2 | 22 | 3602.31 | 2 290.50-5 665.41 | 11.74 | 6.55-21.02 | <.0001 | |
| Month 4 | 27 | 1801.5 | 5490.3 | 10 638.3 | 24 | 4510.41 | 2 801.47-7 261.83 | 16.49 | 8.87-30.68 | <.0001 | |
| Month 15 | 18 | 2127.2 | 3418.6 | 10 095.1 | 18 | 3193.39 | 2 119.71-4 810.91 | 11.39 | 6.68-19.42 | <.0001 | |
| 2 doses gE/AS01B | Month 0 (Pre) | 31 | 166.2 | 300.1 | 432.1 | — | — | — | — | — | — |
| Month 1 | 29 | 134.2 | 234.1 | 354.1 | 28 | 200.58 | 148.07-271.72 | 0.94 | 0.62-1.42 | .7586 | |
| Month 2 | 29 | 389.3 | 725.7 | 1 265.8 | 27 | 644.05 | 434.39-954.89 | 2.60 | 1.51-4.46 | .0007 | |
| Month 3 | 28 | 282.6 | 629.7 | 1 352.9 | 25 | 512.61 | 359.56-730.81 | 2.02 | 1.24-3.27 | .0050 | |
| Month 4 | 24 | 755.4 | 1990.8 | 7 223.2 | 22 | 2220.09 | 1 437.96-3 427.65 | 9.51 | 5.23-17.32 | <.0001 | |
| Month 15 | 18 | 946.1 | 2297.6 | 5 442.5 | 18 | 1363.51 | 886.13-2 098.06 | 5.03 | 2.74-9.26 | <.0001 | |
| 3 doses saline | Month 0 (Pre) | 29 | 229.8 | 356.6 | 693.7 | — | — | — | — | — | — |
| Month 1 | 29 | 178.2 | 340.9 | 594.6 | 25 | 213.99 | 156.04-293.48 | — | — | — | |
| Month 2 | 28 | 195.0 | 318.7 | 494.9 | 26 | 247.85 | 167.47-366.82 | — | — | — | |
| Month 3 | 28 | 176.8 | 394.8 | 573.3 | 24 | 254.30 | 178.44-362.41 | — | — | — | |
| Month 4 | 26 | 116.1 | 246.2 | 621.2 | 22 | 233.39 | 151.95-358.48 | — | — | — | |
| Month 15 | 18 | 221.0 | 292.5 | 389.4 | 17 | 270.97 | 173.08-424.22 | — | — | — | |
| . | . | . | Descriptive statistics . | . | Adjusted geometric mean frequency CD4(2+) . | Adjusted fold increase over saline . | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Group . | Timing . | N . | Q1 . | Median . | Q3 . | N . | Value . | 95% CI . | Value . | 95% CI . | P . |
| 3 doses gE/AS01B | Month 0 (Pre) | 28 | 121.9 | 197.8 | 324.5 | — | — | — | — | — | — |
| Month 1 | 30 | 225.5 | 626.3 | 981.9 | 28 | 588.70 | 434.77-797.13 | 2.75 | 1.80-4.20 | <.0001 | |
| Month 2 | 30 | 2717.6 | 5705.5 | 9 430.9 | 27 | 5131.29 | 3 461.04-7 607.57 | 20.70 | 11.94-35.91 | <.0001 | |
| Month 3 | 28 | 1750.8 | 4377.1 | 10 561.5 | 26 | 4233.37 | 2 977.64-6 018.66 | 16.65 | 10.17-27.25 | <.0001 | |
| Month 4 | 28 | 3888.7 | 7934.2 | 14 416.3 | 25 | 7540.57 | 4 960.60-11 462.36 | 32.31 | 17.78-58.71 | <.0001 | |
| Month 15 | 26 | 2308.8 | 4772.2 | 10 038.1 | 25 | 4104.59 | 2 758.10-6 108.44 | 15.15 | 8.33-27.54 | <.0001 | |
| 3 doses gE/AS01E | Month 0 (Pre) | 27 | 117.1 | 253.6 | 535.7 | — | — | — | — | — | — |
| Month 1 | 29 | 230.2 | 584.8 | 1 268.9 | 27 | 690.55 | 462.24-1 031.63 | 2.65 | 1.58-4.44 | .0004 | |
| Month 2 | 28 | 1829.5 | 3085.5 | 12 615.0 | 24 | 3409.24 | 2 067.87-5 620.73 | 11.54 | 6.01-22.14 | <.0001 | |
| Month 3 | 27 | 1608.6 | 3656.9 | 11 121.2 | 22 | 3602.31 | 2 290.50-5 665.41 | 11.74 | 6.55-21.02 | <.0001 | |
| Month 4 | 27 | 1801.5 | 5490.3 | 10 638.3 | 24 | 4510.41 | 2 801.47-7 261.83 | 16.49 | 8.87-30.68 | <.0001 | |
| Month 15 | 18 | 2127.2 | 3418.6 | 10 095.1 | 18 | 3193.39 | 2 119.71-4 810.91 | 11.39 | 6.68-19.42 | <.0001 | |
| 2 doses gE/AS01B | Month 0 (Pre) | 31 | 166.2 | 300.1 | 432.1 | — | — | — | — | — | — |
| Month 1 | 29 | 134.2 | 234.1 | 354.1 | 28 | 200.58 | 148.07-271.72 | 0.94 | 0.62-1.42 | .7586 | |
| Month 2 | 29 | 389.3 | 725.7 | 1 265.8 | 27 | 644.05 | 434.39-954.89 | 2.60 | 1.51-4.46 | .0007 | |
| Month 3 | 28 | 282.6 | 629.7 | 1 352.9 | 25 | 512.61 | 359.56-730.81 | 2.02 | 1.24-3.27 | .0050 | |
| Month 4 | 24 | 755.4 | 1990.8 | 7 223.2 | 22 | 2220.09 | 1 437.96-3 427.65 | 9.51 | 5.23-17.32 | <.0001 | |
| Month 15 | 18 | 946.1 | 2297.6 | 5 442.5 | 18 | 1363.51 | 886.13-2 098.06 | 5.03 | 2.74-9.26 | <.0001 | |
| 3 doses saline | Month 0 (Pre) | 29 | 229.8 | 356.6 | 693.7 | — | — | — | — | — | — |
| Month 1 | 29 | 178.2 | 340.9 | 594.6 | 25 | 213.99 | 156.04-293.48 | — | — | — | |
| Month 2 | 28 | 195.0 | 318.7 | 494.9 | 26 | 247.85 | 167.47-366.82 | — | — | — | |
| Month 3 | 28 | 176.8 | 394.8 | 573.3 | 24 | 254.30 | 178.44-362.41 | — | — | — | |
| Month 4 | 26 | 116.1 | 246.2 | 621.2 | 22 | 233.39 | 151.95-358.48 | — | — | — | |
| Month 15 | 18 | 221.0 | 292.5 | 389.4 | 17 | 270.97 | 173.08-424.22 | — | — | — | |
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.
CD4(2+), gE-specific CD4+ T cells expressing at least 2 activation markers among interferon-γ, interleukin-2, tumor necrosis factor-α, and CD40 ligand per 106 cells after induction with gE; 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); Q1, first quartile; Q3, third quartile.