Table 3.
A comparison of the immunogenicity of MF59-adjuvanted influenza vaccine and non-adjuvanted influenza vaccine in patients undergoing hemodialysis, 19–64 years.
| A/H1N1 |
A/H3N2 |
B |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| MF59-adjuvanted vaccine | Non-adjuvanted vaccine | P-value | MF59-adjuvanted vaccine | Non-adjuvanted vaccine | P-value | MF59-adjuvanted vaccine | Non-adjuvanted vaccine | P-value | |
| Seroprotection rate, % (95% CI) | |||||||||
| Pre-vaccination | 44.8 (33.5–56.7) | 46.6 (34.3–59.2) | 0.84 | 71.6 (59.9–81.1) | 79.3 (67.1–87.9) | 0.41 | 58.2 (46.3–69.3) | 74.1 (61.5–83.8) | 0.06 |
| 1 month post-vaccination | 85.1 (74.5–91.9) | 69.0 (56.1–79.4) | 0.05 | 97.0 (89.1–99.8) | 89.7 (78.9–95.5) | 0.14 | 92.5 (83.3–97.1) | 84.5 (72.8–91.8) | 0.15 |
| 6 month post-vaccination | 65.5 (52.6–76.5) | 57.7 (44.2–70.1) | 0.40 | 89.7 (78.9–95.5) | 84.6 (72.2–92.2) | 0.43 | 77.6 (65.2–86.5) | 76.9 (63.7–86.4) | 0.93 |
| Seroconversion rate, % (95% CI) | |||||||||
| 1 month post-vaccination | 46.3 (34.9–58.1) | 13.8 (6.9–25.2) | <0.01 | 40.3 (29.4–52.3) | 10.3 (4.5–21.1) | <0.01 | 31.3 (21.5–43.3) | 6.9 (2.2–16.9) | <0.01 |
| 6 month post-vaccination | 22.4 (13.5–34.8) | 15.4 (7.7–27.8) | 0.35 | 24.1 (14.9–36.6) | 11.5 (5.0–23.3) | 0.09 | 13.8 (6.9–25.2) | 7.7 (2.5–18.7) | 0.31 |
| GMT (95% CI) | |||||||||
| Pre-vaccination | 28.1 (20.1–39.5) | 27.0 (19.0–38.3) | 0.86 | 57.5 (42.8–77.2) | 66.9 (50.5–88.5) | 0.46 | 38.8 (31.0–48.5) | 49.0 (39.8–60.3) | 0.13 |
| 1 month post-vaccination | 117.3 (86.9–158.4) | 52.7 (38.1–72.8) | <0.01 | 177.4 (138.6–227.1) | 109.2 (82.3–144.7) | 0.01 | 92.4 (73.4–116.5) | 73.6 (57.5–94.1) | 0.18 |
| 6 month post-vaccination | 55.2 (38.5–79.3) | 35.5 (25.3–49.8) | 0.08 | 100.4 (76.7–131.5) | 81.1 (58.2–113.0) | 0.31 | 60.8 (47.5–77.7) | 51.5 (41.4–64.2) | 0.32 |
| GMT ratio (95% CI) | |||||||||
| 1 month post-vaccination | 4.2 (3.0–5.8) | 2.0 (1.5–2.6) | <0.01 | 3.1 (2.4–4.0) | 1.6 (1.4–1.9) | <0.01 | 2.4 (1.9–3.0) | 1.5 (1.2–1.9) | <0.01 |
| 6 month post-vaccination | 1.9 (1.5–2.5) | 1.6 (1.2–2.1) | 0.28 | 1.8 (1.4–2.2) | 1.3 (1.0–1.6) | 0.03 | 1.5 (1.3–1.8) | 1.1 (0.9–1.3) | 0.01 |
Number of MF59-adjuvanted vaccine recipients followed: 67 at 1 month and 58 at 6 months post-vaccination
Number of non-adjuvanted vaccine recipients followed: 58 at 1 month and 52 at 6 months post-vaccination
Seroprotection rate: the proportion of participants with a HI titer level of ≥1:40
Seroconversion rate: the percentage of subjects with either a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in post-vaccination HI antibody titer from baseline or pre-vaccination HI titer <1:10 and a post-vaccination HI titer of ≥1:40
GMT, geometric mean titer