TABLE 2.
Summary of Vaccine Heterologous HI Antibody Parameters (SPR, GMT, SCR and MGI) at Day 42 (Adapted ATP Cohort for Immunogenicity)
| N | ≥10 1/DIL | SPR | GMT | N′ | SCR | MGI | ||
|---|---|---|---|---|---|---|---|---|
| Antibody | Formulation | n (%; 95% CI) | n (%; 95% CI) | Value (%; 95% CI) | n (%; 95% CI) | Value (%; 95% CI) | ||
| Influenza A/duck/Bangladesh/19097/2013 H5N1 HI (clade 2.3.2.1a) | 1.9 µg HA/AS03B | 32 | 32 (100; 89.1–100) | 32 (100; 89.1–100) | 167.1 (128.4–217.3) | 30 | 30 (100; 88.4–100) | 31.3 (23.5–41.6) |
| 0.9 µg HA/AS03C | 27 | 27 (100; 87.2–100) | 25 (92.6; 75.7–99.1) | 135.3 (97.6–187.5) | 24 | 22 (91.7; 73.0–99.0) | 22.9 (17.2–30.6) | |
| 1.9 µg HA/AS03C | 36 | 36 (100; 90.3–100) | 35 (97.2; 85.5–99.9) | 109.9 (81.2–148.7) | 34 | 33 (97.1; 84.7–99.9) | 20.4 (14.9–28.1) | |
| 3.75 µg HA/AS03C | 31 | 31 (100; 88.8–100) | 28 (90.3; 74.2–98.0) | 91.5 (70.2–119.1) | 25 | 23 (92.0; 74.0–99.0) | 18.9 (14.0–25.5) | |
| 3.75 µg HA/AS03D | 35 | 35 (100; 90.0–100) | 31 (88.6; 73.3–96.8) | 78.5 (58.5–105.3) | 30 | 25 (83.3; 65.3–94.4) | 12.6 (9.0–17.6) | |
| Influenza A/Vietnam/1194/2004 H5N1 HI (clade 1) | 1.9 µg HA/AS03B | 32 | 32 (100; 89.1–100) | 32 (100; 89.1–100) | 128.9 (103.1–161.2) | 30 | 30 (100; 88.4–100) | 24.3 (19.0–31.0) |
| 0.9 µg HA/AS03C | 27 | 27 (100; 87.2–100) | 25 (92.6; 75.7–99.1) | 104.7 (79.0–138.6) | 24 | 22 (91.7; 73.0–99.0) | 20.1 (15.2–26.7) | |
| 1.9 µg HA/AS03C | 36 | 36 (100; 90.3–100) | 31 (86.1; 70.5–95.3) | 88.9 (63.2–125.0) | 34 | 29 (85.3; 68.9–95.0) | 16.7 (11.7–23.8) | |
| 3.75 µg HA/AS03C | 31 | 31 (100; 88.8–100) | 26 (83.9; 66.3–94.5) | 77.2 (59.7–99.9) | 25 | 21 (84.0; 63.9–95.5) | 15.1 (11.1–20.6) | |
| 3.75 µg HA/AS03D | 35 | 35 (100; 90.0–100) | 29 (82.9; 66.4–93.4) | 69.0 (51.7–92.0) | 30 | 24 (80.0; 61.4–92.3) | 11.4 (8.4–15.6) | |
| Influenza A/gyrfalcon/Washington/41088-6/2014 H5N8 HI (clade 2.3.4.4) | 1.9 µg HA/AS03B | 32 | 32 (100; 89.1–100) | 19 (59.4; 40.6–76.3) | 35.8 (27. 9–46.0) | 30 | 17 (56.7; 37.4–74.5) | 6.7 (5.0–9.0) |
| 0.9 µg HA/AS03C | 27 | 27 (100; 87.2–100) | 10 (37.0; 19.4–57.6) | 27.8 (21.1–36.7) | 24 | 9 (37.5; 18.8–59.4) | 5.5 (4.0–7.4) | |
| 1.9 µg HA/AS03C | 36 | 33 (91.7; 77.5–98.2) | 11 (30.6; 16.3–48.1) | 22.8 (17.2–30.3) | 34 | 10 (29.4; 15.1–47.5) | 4.3 (3.2–5.8) | |
| 3.75 µg HA/AS03C | 31 | 30 (96.8; 83.3–99.9) | 7 (22.6; 9.6–41.1) | 21.6 (16.7–27.8) | 25 | 5 (20.0; 6.8–40.7) | 4.1 (3.0–5.6) | |
| 3.75 µg HA/AS03D | 35 | 32 (91.4; 76.9–98.2) | 9 (25.7; 12.5–43.3) | 19.9 (15.4–25.8) | 30 | 8 (26.7; 12.3–45.9) | 3.5 (2. 7–4.6) |
AS03 indicates adjuvant system containing DL-α-tocopherol and squalene in oil-in-water emulsion (AS03B containing 5.93 mg DL-α-tocopherol, AS03C containing 2.97 mg DL-α-tocopherol, and AS03D containing 1.48 mg DL-α-tocopherol); DIL, dilution; N, number of subjects with results available for seropositivity rates, SPR and GMT computation; N', number of subjects with both pre and post results available for SCR and MGI computation; n, number of subjects meeting the SPR; n', number of seroconverted subjects.
MGI is defined as geometric mean of within-subject ratios of post-vaccination reciprocal HI titer to pre-vaccination reciprocal HI titer. SPR is defined as the percentage of subjects with HI titers ≥1:40 post-vaccination. SCR for initially seronegative subjects is defined as percentage of subjects with HI titers ≥1:40 post-vaccination and for initially seropositive subjects it is defined as percentage of subjects with ≥4-fold post-vaccination increase in HI titer from pre-vaccination antibody.