Table 5. Nasal virus-specific secretory IgA responses at Day 39±3 after first nasal administration of trivalent Proteosome influenza vaccine.
Dose group | A/New Caledonia (H1N1) | A/Panama (H3N2) | B Strain† |
---|---|---|---|
Geometric mean fold rise (95% CI) | Geometric mean fold rise (95% CI) | Geometric mean fold rise (95% CI) | |
Day 39±3 | Day 39±3 | Day 39±3 | |
Placebo | 0.93 (0.77–1.12) | 1.04 (0.90–1.21) | 1.02 (0.88–1.17) |
15 μg x 2 | 4.08 (2.87–5.7)** | 4.07 (3.10–5.36)** | 2.66 (2.03–3.49)** |
30 μg x 1 | 1.50 (1.13–1.99)* | 1.66 (1.33–2.08)* | 1.24 (1.03–1.51)* |
30 μg x 2 | 3.93 (2.97–5.”20)** | 3.28 (2.46–4.37)** | 2.45 (1.91–3.14)** |
†B Strain: B/Victoria in Study 1, B/Shandong in Study 2
*p< 0.05 compared to placebo
**p< 0.0001 compared to placebo
There were also significant (p<0.0001) geometric mean fold rises in nasal sIgA specific to A/New Caledonia/20/1999 (H1N1) and the B strains (B/Victoria in Study 1 and B/Shandong in Study 2) at Day 39 for both active two dose groups, with the greatest increases in the 15 μg x 2 treatment group. The increases were lowest in the 30 μg x 1 treatment groups but still significant, p = 0.0007 for A/New Caledonia/20/99 and p = 0.026 for the B strains.
The active two dose groups both showed significantly (p<0.0001) higher increases than the single active dose group for all three strains.