TABLE 1.
HAI and MN responses to homologous and heterologous H5N1 virus strains with AS03-adjuvanted or nonadjuvanted vaccine
| H5 dose (μg) by virus strain | Adjuvant used | Antibody response (95% CI) by assay ata: |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 mo postvaccination |
12 mo postvaccination |
||||||||||
| n | HAI |
MN |
n | HAI |
MN |
||||||
| GMT | % HAI ≥40 | GMT | % MN ≥40 | GMT | % HAI ≥40 | GMT | % MN ≥40 | ||||
| A/Indonesia/05/2005 | |||||||||||
| 3.75 | AS03 | 42 | 14.6 (10.8–19.7) | 24 (12–39) | 70.7 (57.1–87.5) | 93 (81–99) | 38 | 8.3 (6.6–10.6) | 8 (2–21) | 37.2 (28.6–48.4) | 58 (41–74) |
| 3.75 | None | 25 | 6.0 (5.1–7.0) | 0 (0–14) | 12.7 (9.4–17.1) | 16 (5–36) | 25 | 5.2 (5.0–5.5) | 0 (0–14) | 8.2 (6.7–10.1) | 0 (0–14) |
| 7.5 | AS03 | 45 | 25.4 (18.9–34.1) | 44 (30–60) | 118.5 (96.0–146.2) | 100 (92–100) | 39 | 10.1 (7.7–13.2) | 13 (4–27) | 57.6 (44.7–74.2) | 79 (64–91) |
| 7.5 | None | 26 | 5.0 (–) | 0 (0–13) | 9.2 (7.5–11.4) | 0 (0–13) | 24 | 5.0 (–) | 0 (0–14) | 7.4 (5.9–9.2) | 0 (0–14) |
| 15 | AS03 | 43 | 25.5 (18.6–35.0) | 53 (38–69) | 157.4 (123.5–200.7) | 98 (99–100) | 41 | 11.8 (8.9–15.7) | 17 (7–32) | 79.3 (61.4–102.5) | 88 (74–96) |
| 15 | None | 24 | 6.0 (4.9–7.5) | 4 (0–21) | 17.6 (11.6–26.6) | 21 (7–42) | 23 | 5.3 (4.7–6.0) | 0 (0–15) | 11.1 (7.8–15.9) | 9 (1–28) |
| A/Vietnam/1203/2004 | |||||||||||
| 3.75 | AS03 | 42 | 7.4 (5.8–9.4) | 7 (1–19) | 6.8 (6.1–7.5) | 0 (0–8) | 38 | 6.3 (5.1–7.9) | 3 (0–14) | 6.2 (5.6–6.8) | 0 (0–9) |
| 3.75 | None | 25 | 5.7 (4.8–6.6) | 0 (0–14) | 5.2 (5.0–5.5) | 0 (0–14) | 25 | 5.6 (4.8–6.5) | 0 (0–14) | 5.1 (4.9–5.2) | 0 (0–14) |
| 7.5 | AS03 | 45 | 10.2 (7.8–13.3) | 11 (4–24) | 8.9 (7.6–10.4) | 4 (1–15) | 39 | 7.3 (5.8–9.2) | 3 (0–13) | 7.0 (5.9–8.3) | 3 (0–13) |
| 7.5 | None | 26 | 6.3 (5.1–7.7) | 0 (0–13) | 5.1 (4.9–5.2) | 0 (0–13) | 24 | 5.4 (4.8–6.1) | 0 (0–14) | 5.1 (4.9–5.2) | 0 (0–14) |
| 15 | AS03 | 43 | 10.3 (7.7–13.9) | 9 (3–22) | 10.2 (8.5–12.1) | 2 (0–12) | 41 | 7.4 (5.7–9.7) | 7 (2–20) | 8.5 (7.2–10.1) | 0 (0–9) |
| 15 | None | 24 | 6.0 (5.0–7.3) | 0 (0–14) | 6.0 (5.0–7.2) | 0 (0–14) | 23 | 6.6 (5.0–8.7) | 4 (0–22) | 5.6 (4.8–6.6) | 0 (0–15) |
| A/Anhui/01/2005 | |||||||||||
| 3.75 | AS03 | 42 | 6.1 (5.3–7.1) | 0 (0–8) | 46.0 (39.6–53.5) | 76 (61–88) | 38 | 5.0 (5.0–5.1) | 0 (0–9) | 30.1 (24.3–37.4) | 50 (33–67) |
| 3.75 | None | 25 | 5.1 (4.9–5.2) | 0 (0–14) | 13.0 (10.2–16.6) | 4 (0–20) | 25 | 5.0 (–) | 0 (0–14) | 11.0 (9.1–13.3) | 0 (0–14) |
| 7.5 | AS03 | 45 | 6.8 (5.7–8.1) | 2 (0–12) | 64.5 (53.8–77.3) | 96 (85–99) | 39 | 5.4 (4.9–5.9) | 0 (0–9) | 38.3 (31.1–47.1) | 59 (42–74) |
| 7.5 | None | 26 | 5.0 (–) | 0 (0–13) | 11.6 (9.1–14.7) | 8 (1–25) | 24 | 5.0 (–) | 0 (0–14) | 8.5 (6.8–10.7) | 0 (0–14) |
| 15 | AS03 | 43 | 6.7 (5.6–8.0) | 2 (0–12) | 78.7 (64.6–95.9) | 95 (84–99) | 41 | 5.5 (4.9–6.2) | 0 (0–9) | 52.9 (42.5–65.7) | 73 (57–86) |
| 15 | None | 24 | 5.1 (4.8–5.5) | 0 (0–14) | 16.3 (11.6–23.0) | 17 (5–37) | 23 | 5.0 (–) | 0 (0–15) | 12.0 (8.9–16.2) | 9 (1–28) |
| A/turkey/Turkey/1/2005 | |||||||||||
| 3.75 | AS03 | 42 | 5.8 (4.9–7.0) | 5 (1–16) | 33.9 (28.8–40.0) | 50 (34–66) | 38 | 5.8 (4.7–7.1) | 5 (1–18) | 21.7 (17.2–27.3) | 34 (20–51) |
| 3.75 | None | 25 | 5.0 (–) | 0 (0–14) | 8.5 (6.7–10.7) | 0 (0–14) | 25 | 5.0 (–) | 0 (0–14) | 7.0 (5.9–8.2) | 0 (0–14) |
| 7.5 | AS03 | 45 | 10.7 (7.5–15.2) | 24 (13–40) | 50.8 (41.6–62.0) | 73 (58–85) | 39 | 6.4 (5.1–7.9) | 5 (1–17) | 30.6 (24.2–38.8) | 33 (19–50) |
| 7.5 | None | 26 | 5.7 (4.3–7.5) | 4 (0–20) | 7.4 (6.2–8.7) | 0 (0–13) | 24 | 5.0 (–) | 0 (0–14) | 5.8 (5.2–6.4) | 0 (0–14) |
| 15 | AS03 | 43 | 8.2 (6.3–10.8) | 9 (3–22) | 60.8 (49.6–74.6) | 84 (69–93) | 41 | 5.6 (4.8–6.5) | 5 (1–17) | 37.7 (29.8–47.7) | 59 (42–74) |
| 15 | None | 24 | 5.9 (4.2–8.1) | 4 (0–21) | 11.6 (8.2–16.2) | 13 (3–32) | 23 | 5.6 (4.5–6.9) | 4 (0–22) | 8.3 (6.4–10.9) | 4 (0–22) |
| A/Hubei/1/2010 | |||||||||||
| 3.75 | AS03 | 42 | 7.6 (5.8–10.6) | 14 (5–29) | 13.9 (11.5–16.8) | 7 (1–19) | 38 | 5.9 (4.6–7.5) | 5 (1–18) | 10.2 (8.4–12.4) | 5 (1–18) |
| 3.75 | None | 25 | 5.8 (4.4–7.8) | 4 (0–20) | 7.2 (5.9–8.8) | 0 (0–14) | 25 | 5.0 (–) | 0 (0–14) | 6.3 (5.5–7.3) | 0 (0–14) |
| 7.5 | AS03 | 45 | 7.0 (5.4–9.1) | 9 (2–21) | 18.2 (15.1–22.1) | 18 (8–32) | 39 | 6.0 (4.8–7.4) | 5 (1–17) | 11.4 (9.2–14.1) | 8 (2–21) |
| 7.5 | None | 26 | 5.0 (–) | 0 (0–13) | 6.7 (5.5–8.2) | 0 (0–13) | 24 | 5.0 (–) | 0 (0–14) | 6.5 (5.5–7.6) | 0 (0–13) |
| 15 | AS03 | 43 | 6.5 (5.1–8.4) | 7 (1–19) | 23.3 (18.4–29.5) | 21 (10–36) | 41 | 6.2 (4.8–8.1) | 5 (1–17) | 17.8 (13.3–23.8) | 20 (9–35) |
| 15 | None | 24 | 5.3 (4.7–6.0) | 0 (0–14) | 9.6 (6.7–13.6) | 8 (1–27) | 23 | 5.6 (4.8–6.5) | 0 (0–15) | 7.0 (5.2–9.3) | 4 (0–22) |
a
95% CI, 95% confidence interval. The presence of a single dash in parentheses indicates that there is no range for the 95% CI.