Table 2.
Immunogenicity outcomes 1 month post-Tdap vaccination: comparison between adults under active treatment for obstructive airway diseases and the overall study populations of selected studiesa (according-to-protocol cohort).
| OAD-treated adults |
Overall study populations |
|||||||
|---|---|---|---|---|---|---|---|---|
| Meta-analysis | Tdap-002b | Tdap0.3-007 | Tdap0.3-008c | Tdap0.3-008d | Tdap0.3-011 | Zoster-042b | Tdap-003e | |
| Age | ≥18 years | ≥18 years | 19–64 years | 19–64 years | ≥65 years | ≥65 years | ≥50 years | ≥18 years |
| Seroprotection rate, % (95% CI) | ||||||||
| Anti-D | N = 209 | N = 424 | N = 1444 | N = 653 | N = 98 | N = 859 | N = 389 | N = 95 |
| ≥0.1 IU/mL | 89.0 (83.9; 92.9) | 93.6 (90.9; 95.8) | 98.2 (97.4; 98.8) | 94.0 (91.9; 95.7) | 80.6 (71.4; 87.9) | 84.9 (82.3; 87.2) | 94.3 (91.6; 96.4) | 88.4 (80.2; 94.1) |
| ≥1.0 IU/mL | 67.0 (60.2; 73.3) | 64.2 (59.4; 68.7) | 87.9 (86.1; 89.5) | 80.9 (77.6; 83.8) | 50.0 (39.7; 60.3) | 52.0 (48.6; 55.4) | 75.3 (70.7; 79.5) | 70.5 (60.3; 79.4) |
| Anti-T | N = 211 | N = 428 | N = 1445 | N = 654 | N = 102 | N = 864 | N = 394 | N = 95 |
| ≥0.1 IU/mL | 97.2 (93.9; 98.9) | 99.8 (98.7; 100) | 99.6 (99.1; 99.8) | 99.8 (99.2; 100) | 93.1 (86.4; 97.2) | 96.8 (95.4; 97.8) | 99.5 (98.2; 99.9) | 100 (96.2; 100) |
| ≥1.0 IU/mL | 92.4 (88.0; 95.6) | 96.7 (94.6; 98.2) | 98.3 (97.5; 98.9) | 95.0 (93.0; 96.5) | 82.4 (73.6; 89.2) | 88.8 (86.5; 90.8) | 95.7 (93.2; 97.5) | 100 (96.2; 100) |
| Booster response rate, % (95% CI) | ||||||||
| Anti-PT | N = 207 | N = 421 | N = 1419 | N = 627 | N = 97 | N = 846 | N = 389 | N = 95 |
| 78.3 (72.0; 83.7) | 88.4 (84.9; 91.3) | 77.2 (74.9; 79.3) | 84.5 (81.5; 87.3) | 70.1 (60.0; 79.0) | 69.1 (65.9; 72.2) | 71.7 (67.0; 76.1) | 93.7 (86.8; 97.6) | |
| Anti-FHA | N = 204 | N = 415 | N = 1433 | N = 647 | N = 99 | N = 821 | N = 391 | N = 93 |
| 96.1 (92.4; 98.3) | 99.8 (98.7; 100) | 96.9 (95.8; 97.7) | 96.0 (94.2; 97.4) | 91.9 (84.7; 96.4) | 92.8 (90.8; 94.5) | 92.1 (88.9; 94.5) | 96.8 (90.9; 99.3) | |
| Anti-PRN | N = 206 | N = 427 | N = 1441 | N = 652 | N = 100 | N = 864 | N = 387 | N = 95 |
| 92.2 (87.7; 95.5) | 94.1 (91.5; 96.2) | 93.2 (91.8; 94.4) | 90.3 (87.8; 92.5) | 77.0 (67.5; 84.8) | 73.8 (70.8; 76.7) | 83.2 (79.1; 86.8) | 97.9 (92.6; 99.7) | |
Tdap, GSK’s reduced-antigen tetanus, diphtheria and acellular pertussis vaccine; OAD, obstructive airway diseases; CI, confidence interval; D, diphtheria toxoid; N, number of adults with available results; IU, international units; T, tetanus toxoid; PT, pertussis toxoid; FHA, filamentous hemagglutinin; PRN, pertactin.
aSelected studies for the comparator population were the 5 studies included in the meta-analysis (Table S2) and study Tdap-003. Only the study groups vaccinated with Tdap were considered, and for co-administration studies, only the sequential administration groups following Tdap vaccination were considered.
bFor studies Tdap-002 and Zoster-042, the immune response to the pertussis antigens was recalculated following the definition used in the meta-analysis.
cPrimary cohort.
dExploratory cohort.
eFor study Tdap-003, the booster response to PT, FHA and PRN antigens was defined as: post-vaccination antibody concentration ≥5 enzyme-linked immunosorbent assay units (EU)/mL for participants with pre-vaccination antibody concentration <5 EU/mL and post-vaccination antibody concentration ≥2 times the pre-vaccination antibody concentration for participants with pre-vaccination antibody concentration ≥5 EU/mL.