Table 8.
Percent of subjects with significant increases* in virus–specific memory T cells | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CD4+ | CD4+ Tcm** | CD4+ Tеm** | CD8+ | CD8+ Tcm | CD8+ Tеm | Total | |||||||||
Time points | Test article | n (%) | 95% CI | n (%) | 95% CI | n (%) | 95% CI | n (%) | 95% CI | n (%) | 95% CI | n (%) | 95% CI | n (%) | 95% CI |
Day 6 / Day 0 | LAIV (n = 27) | 1 (3.7) | 0.7–18.3 | 0 | 0.0–12.5 | 0 | 0.0–12.5 | 3 (11.1) | 3.9–28.1 | 0 | 0.0–12.5 | 0 | 0.0–12.5 | 3 (11.1) | 3.9–28.1 |
Placebo (n = 10) | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | |
Day 28 / Day 0 | LAIV (n = 27) | 2 (7.4) | 2.1–23.4 | 2 (7.4) | 2.1–23.4 | 3 (11.1) | 3.9–28.1 | 3 (11.1) | 3.9–28.1 | 2 (7.4) | 2.1–23.4 | 3 (11.1) | 3.9–28.1 | 6 (22.2) | 10.6–40.8 |
Placebo (n = 10) | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | |
Day 56 / Day 0 | LAIV (n = 27) | 3 (11.1) | 3.9–28.1 | 3 (11.1) | 3.9–28.1 | 1 (3.7) | 0.7–18.3 | 1 (3.7) | 0.7–18.3 | 1 (3.7) | 0.7–18.3 | 3 (11.1) | 3.9–28.1 | 6 (22.2) | 10.6–40.8 |
Placebo (n = 7) | 0 | 0.0–34.5 | 0 | 0.0–34.5 | 0 | 0.0–34.5 | 0 | 0.0–34.5 | 0 | 0.0–34.5 | 0 | 0.0–34.5 | 0 | 0.0–34.5 | |
Day 112 / Day 0 | LAIV (n = 25) | 5 (20.0) | 8.9–39.1 | 1 (4.0) | 0.7–19.5 | 2; (8.0) | 2.2–25.0 | 3 (12.0) | 4.2–30.0 | 3 (12.0) | 4.2–30.0 | 9 (36.0) | 20.2–55.5 | 11 (44.0) | 26.7–62.9 |
Placebo (n = 7) | 0 | 0.0–34.5 | 0 | 0.0–34.5 | 0 | 0.0–34.5 | 0 | 0.0–34.5 | 0 | 0.0–34.5 | 0 | 0.0–34.5 | 0 | 0.0–34.5 | |
TOTAL | LAIV (n = 27) | 6 (22.2) | 10.6–40.8 | 4 (14.8) | 5.9–32.5 | 4 (14.8) | 5.9–32.5 | 6 (22.2) | 10.6–40.8 | 4 (14.8) | 5.9–32.5 | 12 (44.4) | 27.6–62.7 | 15 (55.6) | 37.3–72.4 |
Placebo (n = 10) | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 | 0 | 0.0–27.8 |
*More than Placebo mean value plus 3 Standard Deviations; CI, 95% confidence interval as calculated by Wilson test;
**Tcm – central memory T cells; Tem – effector memory T cells.