Table 2.
2 vaccine doses with AS03 adjuvant | Group 1§ | P value* | |||
---|---|---|---|---|---|
HA dosage | 3.75 mcg (N=22) | 7.5 mcg (N=29) | 15 mcg (N=34) | 45 mcg (N=17) | |
Baseline * | |||||
GMT (95% CI) | 5.2 (4.8 – 5.5) | 5.8 (5.0 – 6.8) | 5.3 (4.9 – 5.7) | 5.0 ( - ) | |
Titer ≥40 - % (95% CI) | 0 (0–15) | 0 (0–12) | 0 (0–4) | 0 (0–20) | |
Post Vaccination, Strain 1, Wave 1 - A/Shanghai/2/2013 | |||||
GMT (95% CI) | 68.3 (45.5 – 102.7) | 55.9 (36.8 – 84.9) | 62.0 (44.0 – 87.4) | 25.5 (13.5 – 48.2) | 0.0029 |
Titer ≥40 - % (95% CI) | 73 (50–89) | 69 (49–85) | 76 (59–89) | 35 (14–62) | 0.0098 |
Post Vaccination, Strain 2, Wave 1 - A/Anhui/1/2013 | |||||
GMT (95% CI) | 65.2 (44.1 – 96.3) | 53.3 (35.8 – 79.4) | 53.2 (37.9 – 74.7) | 21.3 (12.1 – 37.5) | 0.0013 |
Titer ≥40 - % (95% CI) | 73 (50–89) | 69 (49–85) | 74 (56–87) | 35 (14–62) | 0.0119 |
Post Vaccination, Strain 3, Wave 5-Clade B - A/Chicken/Dongguan/A3217/2016 | |||||
GMT (95% CI) | 80.0 (52.6 – 121.6) | 63.0 (42.0 – 94.4) | 68.0 (48.8 – 94.7) | 34.0 (18.3 – 63.2) | 0.0134 |
Titer ≥40 - % (95% CI) | 77 (55–92) | 72 (53–87) | 79 (62–91) | 53 (28–77) | 0.0716 |
Post Vaccination, Strain 4, Wave 5-Clade B - A/Chicken/Guangzhou/372/2017 | |||||
GMT (95% CI) | 53.1 (36.3 – 77.8) | 46.7 (33.0 – 66.2) | 47.6 (34.7 – 65.1) | 33.3 (18.1 – 61.3) | 0.1189 |
Titer ≥40 - % (95% CI) | 77 (55–92) | 69 (49–85) | 76 (59–89) | 53 (28–77) | 0.1673 |
Post Vaccination, Strain 5, Wave 5-Clade C - A/Zhejiang/5/2017 | |||||
GMT (95% CI) | 33.6 (23.2 – 48.8) | 25.7 (17.4 – 37.9) | 26.6 (19.3 – 36.6) | 15.7 (8.7 – 28.2) | 0.0205 |
Titer ≥ 40 - % (95% CI) | 64 (41–83) | 48 (29–67) | 50 (32–68) | 29 (10–56) | 0.1104 |
Post Vaccination, Strain 6, Wave 5-Clade C - A/Chicken/Huzhou/849/2017 | |||||
GMT (95% CI) | 25.3 (17.1 – 37.5) | 21.5 (15.1 – 30.5) | 22.1 (16.6 – 29.5) | 12.3 (7.0 – 21.6) | 0.0077 |
Titer ≥ 40 - % (95% CI) | 45 (24–68) | 28 (13–47) | 35 (20–54) | 12 (1–36) | 0.0841 |
Post Vaccination, Strain 7, Wave 5-Clade C - A/Chicken/Shantou/39/2017 | |||||
GMT (95% CI) | 29.2 (19.3 – 44.2) | 26.0 (17.9 – 37.9) | 23.8 (17.4 – 32.4) | 13.9 (7.5 – 25.5) | 0.0138 |
Titer ≥ 40 - % (95% CI) | 50 (28–72) | 48 (29–67) | 44 (27–62) | 24 (7–50) | 0.1071 |
Post Vaccination, Strain 8, Wave 5-Clade C (HPAI) - A/Chicken/Shantou/9204/2016 | |||||
GMT (95% CI) | 9.0 (6.9 – 11.7) | 8.7 (6.9 – 10.9) | 8.2 (7.0 – 9.4) | 6.8 (4.8 – 9.7) | 0.0072 |
Titer ≥ 40 - % (95% CI) | 0 (0–15) | 3 (0–18) | 0 (0–10) | 12 (1–36) | 0.0713 |
Post Vaccination, Strain 9, Wave 5-Clade C (HPAI) - A/Guangzhou/17SF003RG/2017 | |||||
GMT (95% CI) | 10.7 (8.1 – 14.0) | 12.1 (9.7 – 15.1) | 11.7 (9.6 – 14.1) | 12.0 (7.0 – 20.5) | 0.5267 |
Titer ≥ 40 - % (95% CI) | 9 (1–29) | 3 (0–18) | 3 (0–15) | 12 (1–36) | 0.2611 |
The baseline antibody titers were measured against strain 1; the baseline against the other strains were similar.
Seroprotection and seroconversion titers were nearly identical. So we present only seroprotection data.
P value in comparing the responses in the recipients of 1 dose of unadjuvanted boost vaccination at the 45mcg HA dosage (N=17) to a combined group of recipients of 2 doses of adjuvanted vaccine at all HA dosages (N=85) using a Fisher’s exact test for comparisons of proportional endpoints, and Wilcoxon comparisons of titers.
Group 1 subjects are prior recipients of IIV1 A/H7N7.