Table 4. Booster response to 30 μg adjuvanted clade 2/ Indonesia/5/05-RG2 vaccine at 22 months following the first vaccination.
| 18 to 60 years | > 60 years | |||||
|---|---|---|---|---|---|---|
| Strain used to test response | Clade 1 (Vietnam) | Clade 2 (Indonesian) | Clade 1 (Vietnam) | Clade 2 (Indonesian) | ||
| EMA threshold | Time after vaccination (days) | N = 59 | N = 59 | N = 57 | N = 57 | |
| GMT (95% CI) | None | 7 | 12.1 (9.35; 15.8) | 12.6 (9.56; 16.5) | 8.25 (6.25; 10.9) | 6.16 (5.02; 7.56) |
| 21 | 14.4 (10.8; 19.2) | 15.2 (11.3; 20.3) | 10.7 (7.71; 14.9) | 9.84 (7.06; 13.7) | ||
| GMTR (95% CI) | >2.5 or > 2# | 7 | 2.93 (2.28; 3.77) | 3.07 (2.34; 4.03) | 1.54 (1.25; 1.90) | 1.49 (1.21; 1.82) |
| 21 | 3.47 (2.63; 4.59) | 3.71 (2.78; 4.94) | 2.01 (1.50; 2.71) | 2.39 (1.72; 3.33) | ||
| Seroconversion* % (95% CI) | > 40% or 30%# | 7 | 27.1 (16.4; 40.3) | 28.8 (17.8; 42.1) | 12.5 (5.2; 24.1) | 8.9 (3.0; 19.6) |
| 21 | 39 (26.5; 52.6) | 42.4 (29.6; 55.9) | 17.9 (8.9; 30.4) | 21.4 (11.6; 34.4) | ||
| GMTtitre ≥ 32% (95% CI) | > 70% or > 60%# | 7 | 27.1 (16.4; 40.3) | 28.8 (17.8; 42.1) | 22.8 (12.7; 35.8) | 10.5 (4.0; 21.5) |
| 21 | 39 (26.5; 52.6) | 42.2 (29.6; 55.9) | 26.3 (15.5; 39.7) | 22.8 (12.7; 35.8) | ||
EMA: European Medicines Authority
GMT: Geometric mean titer
GMTR: Geometric mean titer ratio (post-vaccination titer/pre-vaccination titer)
*Seroconversion: subjects with pre-vaccination titers < 8 and post-vaccination titres > 32 or significant increase in titres defined as pre-vaccination titre < 8 with at least a 4-fold increase in post-vaccination titers about 3 weeks after vaccination
# Modified EMA criteria for adults aged over 60 years of age
Numbers shown in bold are those which meet the specified EMA criterion