Table 3. Dynamic changes of hemagglutination-inhibition (HI) immunogenicity during the 18-week study period in the elderly dialysis patients (age over 60 years-old).
| Dialysis population | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Immunogenicity end point | The unvaccinated group (n = 13) |
The one-dose vaccination group (n = 50) |
The two-dose vaccination group (n = 24) |
||||||
| H1N1 | H3N2 | B | H1N1 | H3N2 | B | H1N1 | H3N2 | B | |
| Baseline | |||||||||
| Seroprotection rate % (95% CI) | 7.7% (0.2–36.0) | 0.0% (0–24.7) | 0.0% (0–24.7) | 16.0% (7.2–29.1) | 32.0% (19.5–46.7)a | 8.0% (2.2–19.2) | 4.2% (0.1–21.1) | 29.2% (12.6–51.1)a | 8.3% (1.0–27.0) |
| Geometric mean titer (95% CI) | 9.0 (5.3–15.4) | 5.3 (4.7–5.9) | 5.0 (5.0–5.0) | 9.4 (6.8–12.9) | 13.4 (9.3–19.3)a | 6.2 (5.2–7.5) | 7.5 (5.5–10.2) | 17.8 (10.9–29.2)a | 6.1 (4.8–7.9) |
| 3 weeks later | |||||||||
| Seroprotection rate % (95% CI) | 7.7% (0.2–36.0) | 0.0% (0–24.7) | 0.0% (0–24.7) | 54.0% (39.3–68.2)a | 58.0% (43.2–71.8) | 4.0% (0.5–13.7) | 33.3% (15.6–55.3)a | 58.3% (36.6–77.9) | 12.5% (2.7–32.4) |
| Geometric mean titer (95% CI) | 7.7 (4.5–13.0) | 5.3 (4.7–5.9) | 5.0 (5.0–5.0) | 29.5 (18.9–46.0)a | 37.3 (23.5–59.2)a | 7.6 (6.2–9.2) | 18.3 (10.4–32.4)a | 43.6 (24.6–77.5)a | 6.5 (4.8–8.7) |
| Fold increase of GM titer(95% CI) | 0.9 (0.7–1.1) | 1.0 (1.0–1.0) | 1.0 (1.0–1.0) | 3.1 (2.1–4.6)a | 2.8 (1.8–4.4)a | 1.2 (1.0v1.5) | 2.4 (1.4–4.3)a | 2.4 (1.5–4.1)a | 1.1 (0.9–1.3) |
| Seroresponse rate % (95% CI) | 0.0% (0–24.7) | 0.0% (0–24.7) | 0% (0–24.7) | 42.0% (28.2–56.8)a | 44.0% (30.0–58.8)a | 12.0% (4.5–24.3) | 41.7% (22.1–63.4)a | 41.7% (22.1–63.4)a | 4.2% (0.1–21.1) |
| Seroconversion rate % (95% CI) | 0% (0–24.7) | 0.0% (0–24.7) | 0% (0–24.7) | 36.0% (22.9–50.8)a | 36.0% (22.9–50.8)a | 0.0% (0.0–7.1) | 20.8% (7.1–42.2) | 33.3% (15.6–55.3)a | 4.2% (0.1–21.1) |
| 6 weeks later | |||||||||
| Seroprotection rate % (95% CI) | 7.7% (0.2–36.0) | 0.0% (0–24.7) | 0.0% (0–24.7) | 46.0% (31.8–60.7)a | 58.0% (43.2–71.8) | 6.0% (1.3–16.6) | 37.5% (18.8–59.4)a | 58.3% (36.6–77.9) | 4.2% (0.1–21.1) |
| Geometric mean titer (95% CI) | 7.7 (4.6–12.6) | 6.2 (4.5–8.5) | 5.0 (5.0–5.0) | 21.4 (14.6–31.4)a | 40.6 (25.3–65.1)a | 6.9 (5.7–8.3) | 20.0 (10.5–37.9)a | 43.6 (22.2–85.8)a | 6.1 (4.9–7.6) |
| Fold increase of GM titer (95% CI) | 0.9 (0.6–1.2) | 1.2 (0.9–1.5) | 1.0 (1.0–1.0) | 2.3 (1.6–3.3)a | 3.0 (1.9–4.9)a | 1.1 (0.9–1.3) | 2.7 (1.5–4.9)a | 2.4 (1.4–4.3)a | 1.0 (0.8–1.3) |
| Seroresponse rate % (95% CI) | 0.0% (0–24.7) | 7.7% (0.2–36.0) | 0.0% (0–24.7) | 38.0% (24.7–52.8)a | 42.0% (28.2–56.8)a | 6.0% (1.3–16.6) | 37.5% (18.8–59.4)a | 41.7% (22.1–63.4) | 4.2% (0.1–21.1) |
| Seroconversion rate % (95% CI) | 0.0% (0–24.7) | 0.0% (0–24.7) | 0.0% (0–24.7) | 30.0% (17.9–44.6)a | 38.0% (24.7–52.8)a | 0.0% (0.0–7.1) | 25.0% (9.8–46.7) | 37.5%(18.8–59.4)a | 0.0% (0.0–14.3) |
| 9 weeks later | |||||||||
| Seroprotection rate % (95% CI) | 7.7% (0.2–36.0) | 0.0% (0.0–24.7) | 0.0% (0.0–24.7) | 46.0% (31.8–60.7)a | 62.0% (47.2–75.4) | 10.0% (3.3–21.8) | 37.5% (18.8–59.4)a | 66.7% (44.7–84.4) | 16.7% (4.7–37.4) |
| Geometric mean titer (95% CI) | 9.0 (4.9–16.6) | 5.3 (4.7–5.9) | 5.0 (5.0–5.0) | 21.7 (14.6–32.5)a | 41.1 (25.8–65.4)a | 7.4 (5.9–9.3)a | 20.6 (10.7–39.6)a | 50.4 (27.4–92.6)a | 8.4 (5.6–12.6) |
| Fold increase of GM titer (95% CI) | 1.0 (0.8–1.2) | 1.0 (1.0v1.0) | 1.0 (1.0–1.0) | 2.3 (1.6–3.4)a | 3.1 (1.9–5.0)a | 1.2 (1.0–1.4) | 2.7 (1.5–5.1)a | 2.8 (1.7–4.6)a | 1.4 (0.9–2.1) |
| Seroresponse rate % (95% CI) | 0.0% (0.0–24.7) | 0.0% (0.0–24.7) | 0.0% (0.0–24.7) | 40.0% (26.4–54.8)a | 36.0% (22.9–50.8)a | 8.0% (2.2–19.2) | 37.5% (18.8–59.4)a | 50.0% (29.1–70.9)a | 16.7% (4.7–37.4) |
| Seroconversion rate % (95% CI) | 0.0% (0.0–24.7) | 0.0% (0.0–24.7) | 0.0% (0.0–24.7) | 32.0% (19.5–46.7)a | 34.0% (21.2–48.8)a | 2.0% (0.1–10.7) | 29.2% (12.6–51.1)a | 45.8% (25.6–67.2)a | 0.0% (0.0–14.3) |
| 18 weeks later | |||||||||
| Seroprotection rate % (95% CI) | 7.7% (0.2–36.0) | 0.0% (0.0–24.7) | 7.7% (0.2–36.0) | 16.0% (7.2–29.1) | 30.0% (17.9–44.6) | 4.0% (0.5–13.7) | 20.8% (7.1–41.2) | 33.3% (15.6–55.3) | 0.0% (0.0–14.3) |
| Geometric mean titer (95% CI) | 8.1 (4.8–13.6) | 5.0 (5.0-5.0) | 6.2 (3.9–9.9) | 9.3 (6.5–13.4) | 11.7 (8.2–16.5) | 5.5 (4.8–6.3) | 13.4 (7.7–23.2)a | 18.9 (9.7–36.6) | 5.0 (5.0–5.0) |
| Fold increase of GM titer (95% CI) | 0.9 (0.8–1.1) | 0.9 (0.8–1.1) | 1.2 (0.8–2.0) | 1.0 (0.7–1.5) | 0.9 (0.5–1.4) | 0.9 (0.8–1.0) | 1.8 (1.0–3.2)a | 1.1 (0.6–1.9) | 0.8 (0.6–1.1) |
| Seroresponse rate % (95% CI) | 0.0% (0.0–24.7) | 0.0% (0.0–24.7) | 7.7% (0.2–36.0) | 14.0% (5.8–26.7) | 16.0% (7.2–29.1) | 0.0% (0.0–7.1) | 29.2% (12.6–51.1)a | 20.8% (7.1–42.2) | 0.0% (0.0–14.3) |
| Seroconversion rate % (95% CI) | 0.0% (0.0–24.7) | 0.0% (0.0–24.7) | 0.0% (0.0–24.7) | 10.0% (3.3–21.8) | 12.0% (4.5–24.3) | 0.0% (0.0–7.1) | 16.7% (4.7–37.4) | 16.7% (4.7–37.4) | 0.0% (0.0–14.3) |
Abbreviations: CI: confidence interval; GM: geographic mean; Definition of seroprotection: HI titers ≥ 1:40; Seroresponse: ≥ 4-fold increase in antibody titer after vaccination; Seroconversion: ≥ 4-fold or more increase in HI titer and HI titer ≥ 1:40 after vaccination.
aP value < 0.05 compared with the unvaccinated group.
bThere were no statistical differences between all immunogenic profiles between the one-dose and two-dose vaccination groups.