Table 2.
Immunological findings for the primary outcomes. Geometric mean titers, geometric mean fold rise, and geometric mean ratios (compared with the original vaccine) of neutralization titers against the ancestral strain and against the BA.1 Omicron strain for each of the study arms
| Outcome | Visit | BNT162b2 | BNT162b2 OMI | BNT162b2/BNT162b2 OMI | |||
|---|---|---|---|---|---|---|---|
| 30 μg | 60 μg | 30 μg | 60 μg | 15 μg/15 μg | 30 μg/30 μg | ||
| Geometric mean titer | |||||||
| Direct neutralization–ancestral strain (titer) | 0 | 557 (361.7–857.7) | 382.4 (176.3–829.3) | 419.3 (228.1–770.5) | 315.2 (188–528.4) | 803.4 (347.8–1855.8) | 256 (135.1–485) |
| 1 | 1854.9 (1134.4–3033) | 1241.4 (624.3–2468.6) | 1321.9 (739.5–2363.1) | 1499.2 (838.6–2680.4) | 2549.1 (1306.2–4974.9) | 1845.8 (1087.4–3133.1) | |
| 2 | 4390 (2924.3–6590.3) | 2048.4 (1007.8–4163.7) | 3010 (1606.2–5640.8) | 3807.8 (2092.7–6928.6) | 5287.7 (3205.1–8723.5) | 2521.4 (1388.9–4577.4) | |
| 3 | 2246.3 (1308.7–3855.7) | 1166.1 (617.5–2202.1) | 1765.3 (705.1–4419.6) | 1949.1 (941.9–4033.4) | 2314.5 (1229–4358.6) | 1255.6 (679.3–2320.6) | |
| Direct neutralization–BA.1 (titer) | 0 | 28.5 (10.8–75.6) | 26.4 (10.8–64.4) | 12.9 (3.5–47.2) | 29.5 (11.4–76.8) | 63.3 (19.2–208.1) | 14.2 (6.1–33) |
| 1 | 146.1 (102.5–208.2) | 101.6 (48.6–212.6) | 184.4 (81.1–419) | 315.2 (164.6–603.5) | 330.5 (124.2–879.3) | 222.9 (125.7–395.1) | |
| 2 | 401.7 (236.7–681.9) | 188.1 (88.9–398.2) | 574.7 (333.2–991.1) | 764.8 (394.6–1482.4) | 1062 (509.6–2213.2) | 477.7 (236–967.1) | |
| 3 | 154 (74–320.2) | 94.5 (45.7–195.3) | 327.9 (111–968.6) | 512 (268–978) | 435 (191.2–989.2) | 245.8 (108.1–558.7) | |
| Geometric mean fold rise | |||||||
| Direct neutralization–wild-type | 1 | 3.3 (2.5–4.5) | 3.1 (1.8–5.2) | 3.1 (2–4.6) | 4.8 (3–7.5) | 2.9 (1.2–6.8) | 6.3 (3.9–10.2) |
| 2 | 7.5 (5–11.4) | 5 (2.5–10) | 6.5 (4.3–10.1) | 12.4 (6.7–22.9) | 6 (3.4–10.5) | 8.6 (4.1–17.8) | |
| 3 | 3.4 (2–5.7) | 2.6 (1.3–5.2) | 3.4 (1.6–7.2) | 6.2 (2.7–14.2) | 3 (1.6–5.6) | 3.7 (2–6.7) | |
| Direct neutralization–BA.1 | 1 | 5.5 (2.4–12.6) | 3.7 (1.9–7.6) | 15.6 (6.2–39.2) | 10.7 (5.1–22.2) | 4.7 (1.6–13.3) | 12.3 (7–21.4) |
| 2 | 14.7 (6–36.5) | 6.9 (3–15.9) | 37.3 (12.6–110) | 26 (10.7–63.2) | 15 (6.2–36.7) | 26.3 (13.8–49.9) | |
| 3 | 5 (1.8–13.9) | 2.3 (1.2–4.4) | 17.4 (5.6–53.7) | 11.3 (4.9–25.9) | 7.2 (2.7–19.1) | 12.2 (7.2–20.8) | |
| Geometric mean ratio | |||||||
| Direct neutralization–wild-type | 1 | REF | 0.8 (0.44–1.48) | 0.83 (0.45–1.51) | 1.13 (0.62–2.04) | 1.05 (0.58–1.93) | 1.44 (0.79–2.62) |
| 2 | REF | 0.56 (0.29–1.05) | 0.77 (0.41–1.46) | 1.18 (0.63–2.23) | 0.98 (0.52–1.85) | 0.8 (0.43–1.5) | |
| 3 | REF | 0.63 (0.3–1.32) | 0.9 (0.42–1.92) | 1.28 (0.6–2.75) | 0.96 (0.46–1.97) | 0.79 (0.38–1.63) | |
| Direct neutralization–BA.1 | 1 | REF | 0.69 (0.33–1.43) | 1.78 (0.86–3.65) | 2.06 (1.02–4.18) | 1.5 (0.73–3.08) | 1.79 (0.88–3.64) |
| 2 | REF | 0.47 (0.23–0.97) | 1.75 (0.84–3.64) | 1.85 (0.9–3.81) | 1.89 (0.91–3.92) | 1.37 (0.67–2.8) | |
| 3 | REF | 0.54 (0.24–1.2) | 2.69 (1.17–6.17) | 2.79 (1.21–6.41) | 2.07 (0.93–4.58) | 1.95 (0.88–4.32) | |