Table II.
Baseline and Day 28 Post-vaccination Immune Response Summary
| NA ID | Moderate/Severe AD ID | Moderate/Severe AD IM | NA IM | |||
|---|---|---|---|---|---|---|
|
| ||||||
| Moderate/Severe AD ID vs. NA ID | Moderate/Severe AD ID vs. AD IM | |||||
| B | ||||||
| N | 102 | 96 | 92 | 18 | ||
| Baseline GMT (95% CI) | 7.5 (6.8, 8.3) | 6.7 (6.1, 7.3) | 7.4 (6.7, 8.2) | 6.1 (4.8, 7.6) | ||
| Day 28 GMT (95% CI) | 16.4 (13.6, 19.8) | 20.4 (16.3, 25.6) | 21.4 (17.5, 26.2) | 20.0 (15.0, 26.7) | ||
| GM Fold Increase (95% CI) | 2.2 (1.8, 2.6) | 3.1 (2.4, 3.9) | 2.9 (2.4, 3.5) | 3.3 (2.2, 4.9) | ||
| GM Ratio (95% CI) | 1.25 (0.96, 1.61) | 0.93 (0.71, 1.22) | ||||
| p = .09 | p = .61 | |||||
| Seroprotection % (95% CI) | 23% (15, 32) | 34% (25, 45) | 34% (24, 44) | 22% (6.4, 48) | ||
| Odds Ratio (95% CI) | 1.80 (0.92, 3.55) | 1.03 (0.54, 1.97) | ||||
| p = .08 | p > .99 | |||||
| Seroconversion % (95% CI) | 30% (22, 40) | 41% (31, 51) | 48% (37, 58) | 61% (36, 83) | ||
| Odds Ratio (95% CI) | 1.57 (0.84, 2.94) | 0.75 (0.40, 1.38) | ||||
| p = .14 | p = .38 | |||||
| H1N1 | ||||||
| N | 59 | 63 | 53 | 10 | ||
| Baseline GMT (95% CI) | 7.9 (6.8, 9.1) | 7.8 (6.7, 9.0) | 8.8 (7.5, 10.3) | 12.3 (7.7, 19.7) | ||
| Day 28 GMT (95% CI) | 230 (151, 352) | 142 (95.6, 210) | 180 (125, 260) | 106 (43.7, 255) | ||
| GM Fold Increase (95% CI) | 29.1 (18.3, 46.3) | 18.3 (12.3, 27.1) | 20.5 (13.4, 31.3) | 8.6 (3.0, 24.7) | ||
| GM Ratio (95% CI) | 0.59 (0.32, 1.11) | 0.91 (0.50, 1.65) | ||||
| p = .10 | p = .75 | |||||
| Seroprotection % (95% CI) | 86% (75, 94) | 84% (73, 92) | 92% (82, 98) | 90% (55,100) | ||
| Odds Ratio (95% CI) | 0.83 (0.26, 2.56) | 0.43 (0.09, 1.63) | ||||
| p = .80 | p = .25 | |||||
| Seroconversion % (95% CI) | 88% (77, 95) | 86% (75, 93) | 89% (77, 96) | 60% (26, 88) | ||
| Odds Ratio (95% CI) | 0.81 (0.24 ,2.65) | 0.77 (0.21, 2.62) | ||||
| p = .79 | p = .78 | |||||
| H3N2 | ||||||
| N | 60 | 59 | 49 | 11 | ||
| Baseline GMT (95% CI) | 8.8 (7.6, 10.2) | 9.8 (8.3, 11.5) | 9.1 (7.7, 10.7) | 8.3 (5.7, 11.9) | ||
| Day 28 GMT (95% CI) | 79.1 (54.4, 115) | 93.2 (64.1, 135) | 108 (78.2, 148) | 75.1 (29.3, 193) | ||
| GM Fold Increase (95% CI) | 9.0 (6.2, 13.0) | 9.5 (6.6, 13.9) | 11.9 (8.2, 17.2) | 9.1 (3.2, 25.6) | ||
| GM Ratio (95% CI) | 1.04 (0.60, 1.80) | 0.76 (0.44, 1.31) | ||||
| p = .90 | p = .32 | |||||
| Seroprotection % (95% CI) | 73% (60, 84) | 85% (73, 93) | 94% (83, 99) | 91% (59,100) | ||
| Odds Ratio (95% CI) | 2.02 (0.75, 5.71) | 0.36 (0.06, 1.58) | ||||
| p = .18 | p = .22 | |||||
| Seroconversion % (95% CI) | 73% (60, 84) | 76% (63, 86) | 88% (75, 95) | 82% (48, 98) | ||
| Odds Ratio (95% CI) | 1.17 (0.47, 2.92) | 0.45 (0.13, 1.39) | ||||
| p = .83 | p = .14 | |||||
Notes: NA=Non-Atopic; AD=Atopic Dermatitis; ID=Intradermal; IM=Intramuscular, GMT=Geometric Mean Titer, GM=Geometric Mean, CI=Confidence Interval. Fold increase is defined as the day 28 hemagglutination-inhibition (HAI) antibody titer divided by the baseline HAI antibody titer. Seroprotection is defined as a day 28 HAI antibody titer ≥1:40. Seroconversion is defined as a ≥4-fold increase in HAI antibody titer from baseline to day 28. HAI antibody titers of <1:10 have been imputed as 1:5 and titers of ≥1:1280 have been imputed as 1:2560 for analyses. Participants with a baseline HAI antibody titer ≥1:40 for a particular strain are excluded from the analyses of that strain. GMT and GM fold increase statistics are raw estimates. GM ratios, 95% CIs and p-values are from pairwise robust regression models of log2 HAI titer fold-increase, adjusting for age and gender. Odds ratio 95% CIs are exact estimates and p-values are from pairwise Fisher’s exact tests. GM ratios and odds ratios compare the moderate/severe AD ID group to the adjacent groups.