Table 5.
Bivalent Vaccine Efficacy Determined by TypeSeq and SPF10-LiPA
| HPV16/18 | HPV31, 33, 45 | Other (HPV35, 39, 51, 52, 56, 58, 59) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ATP | ITT | ATP | ITT | ATP | ITT | ||||||||
| Assay | Trial Arm | Events/ Women | VE (%) (95% CI) | Events/ Women | VE (%) (95% CI) | Events/ Women | VE (%) (95% CI) | Events/ Women | VE (%) (95% CI) | Events/ Women | VE (%) (95% CI) | Events/ Women | VE (%) (95% CI) |
| All Women Tested by TypeSeq | |||||||||||||
| SPF10-LiPA | HPV | 49/820 | 66.6 | 62/1104 | 69.2 | 69/823 | 45.7 | 99/1104 | 39.4 | 153/824 | 12.7 | 208/1104 | 9.8 |
| HAV | 164/916 | (54.3–75.9) | 228/1250 | (59.4–76.9) | 142/920 | (27.8–59.4) | 185/1250 | (22.8–52.7) | 196/922 | (−7.9 to 29.4) | 261/1250 | (−8.2 to 24.8) | |
| TypeSeq | HPV | 43/820 | 70.2 | 60/1104 | 69.5 | 66/823 | 52.7 | 90/1104 | 49.6 | 182/824 | 13.7 | 246/1104 | 7.8 |
| HAV | 161/916 | (58.5–78.9) | 223/1250 | (59.7–77.2) | 156/920 | (37.1–64.7) | 202/1250 | (35.5–60.8) | 236/922 | (−4.7 to 28.9) | 302/1250 | (−9.1 to 22.1 | |
| Random Sample From Both Arms | |||||||||||||
| SPF10-LiPA | HPV | 16/741 | 72.6 | 20/998 | 74.0 | 20/742 | 64.4 | 32/998 | 53.5 | 127/743 | 1.2 | 175/998 | −6.3 |
| HAV | 58/735 | (53.2–84.7) | 77/1000 | (58.0–84.4) | 56/739 | (41.4–79.1) | 69/1000 | (29.7–69.8) | 128/740 | (−26.4 to 22.7) | 165/1000 | (−31.5 to 14.1) | |
| TypeSeq | HPV | 17/741 | 73.2 | 26/998 | 69.0 | 23/742 | 67.3 | 35/998 | 58.2 | 153/743 | 4.2 | 212/998 | −8.4 |
| HAV | 63/735 | (55.0–84.7) | 84/1000 | (52.3–80.3) | 70/739 | (48.1–79.9) | 84/1000 | (38.4–72.1) | 159/740 | (−19.7 to 23.3) | 196/1000 | (−31.7 to 10.8) | |
| Random Sample Weighted Back to Full Study | |||||||||||||
| SPF10-LiPA | HPV | 49/2379 | 70.4 | 62/3175 | 72.7 | 69/2384 | 51.8 | 100/3175 | 46.3 | 385/2387 | 2.7 | 516/3175 | 0.3 |
| HAV | 164/2340 | (61.6–77.2) | 228/3167 | (66.3–77.9) | 142/2352 | (39.7–61.4) | 185/3167 | (37.0–54.2) | 390/2354 | (−19.9 to 21.1) | 516/3167 | (−19.5 to 16.8) | |
| TypeSeq | HPV | 55/2379 | 67.9 | 82/3175 | 65.7 | 82/2384 | 55.9 | 112/3175 | 52.6 | 460/2387 | 6.0 | 623/3175 | −2.8 |
| HAV | 169/2340 | (54.6–77.4) | 239/3167 | (54.0–74.5) | 184/2352 | (40.9–67.1) | 236/3167 | (39.5–62.8) | 483/2354 | (−13.2 to 22.1) | 605/3167 | (−21.0 to 12.7) | |
Abbreviations: ATP, according-to-protocol; CI, confidence interval; HAV, control arm; HPV, vaccine arm; ITT, intention-to-treat; VE, vaccine efficacy.