Table 3.
Immunogenicity end points against seasonal strains in kidney transplant recipients and healthy controls
| Values and timelines | Pandemic vaccine alone followed by seasonal vaccine alone |
Pandemic vaccine + seasonal vaccine |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Transplant recipients (n = 16) |
Healthy controls (n = 16) |
Transplant recipients (n = 16) |
Healthy controls (n = 16) |
|||||||||
| A/H1N1 | A/H3N2 | B | A/H1N1 | A/H3N2 | B | A/H1N1 | A/H3N2 | B | A/H1N1 | A/H3N2 | B | |
| Seroconversion, n (%) | ||||||||||||
| Baseline | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| 28 ± 2 days post-dose 1 | 2 (12.5)^ | 2 (12.5)^ | 0 (0.0)^ | 14 (87.5) | 14 (87.5) | 14 (87.5) | 4 (25.0)* | 4 (25.0)* | 3 (18.8)*° | 15 (93.8) | 15 (93.8) | 14 (87.5) |
| 56 ± 2 days post-dose 1 | 3 (18.8)^ | 3 (18.8)^ | 1 (6.3)^ | 15 (93.8) | 15 (93.8) | 15 (93.8) | 5 (31.3)* | 6 (37.5)* | 3 (18.8)*° | 16 (100.0) | 16 (100.0) | 14 (87.5) |
| GMT (fold increase) | ||||||||||||
| Baseline | 27.81 (NA) | 28.13 (NA) | 22.81 (NA) | 25.82 (NA)# | 57.61 (NA)# | 15.61 (NA)# | 32.5 (NA)# | 47.81 (NA) | 13.13 (NA) | 39.31 (NA)# | 31.19 (NA)# | 15.83
(NA)# |
| 28 ± 2 days post-dose 1 | 43.13 (1.6)^ | 51.25
(1.8)^ |
36.25 (1.6)^ | 233.69 (9.1) | 255.16 (4.4) | 58.19 (3.7) | 109.38 (3.4)* | 70.63 (1.5)* | 26.88 (2.0)* | 733.76 (18.7)^ | 491.52 (15.8)^ | 61.16 (3.9) |
| 56 ± 2 days post-dose 1 | 51.25 (1.8)^ | 59.38 (2.1)^ | 28.75 (1.3)^ | 249.36 (9.7) | 260.36 (4.5) | 55.39 (3.5) | 117.61 (3.6)* | 84.38 (1.8)* | 23.13 (1.8)* | 810.16 (20.6)^ | 449.39 (14.4)^ | 63.76 (4.0) |
| Seroprotection, n (%) | ||||||||||||
| Baseline | 5 (31.3) | 5 (31.3) | 2 (12.5) | 5 (31.3)# | 5 (31.3)# | 3 (18.8)# | 6 (37.5) | 6 (37.5) | 1 (6.3) | 5 (31.3)# | 6 (37.5)# | 1 (6.3)# |
| 28 ± 2 days post-dose 1 | 7 (43.8) | 8 (50.0) | 4 (25.0) | 14 (87.5) | 15 (93.8) | 15 (93.8) | 11 (68.8) | 10 (62.5) | 5 (31.3) | 15 (93.8) | 14 (87.5) | 14 (87.5) |
| 56 ± 2 days post-dose 1 | 7 (43.8) | 8 (50.0) | 5 (31.3) | 15 (93.8) | 15 (93.8) | 15 (93.8) | 12 (75.0) | 12 (75.0) | 5 (31.3) | 16 (100.0) | 15 (93.8) | 15 (93.8) |
NA, not applicable.
^P < 0.05 vs healthy controls administered pandemic vaccine alone followed by seasonal vaccine alone.
#P < 0.05 vs 28 ± 2 days post-dose 1 and vs 56 ± 2 days post-dose 1.
*P < 0.05 vs healthy controls administered pandemic vaccine + seasonal vaccine.
°P < 0.05 vs transplant recipients administered pandemic vaccine alone followed by seasonal vaccine alone.