Table 3.
Impact of the 9vHPV Vaccine on the Incidence of HPV-31/33/45/52/58–Related Persistent Infection; Cervical, Vulvar, and Vaginal Disease; Cervical Cytological Abnormalities; and Cervical Medical Procedures in Asian Participants (Young Women Aged 16–26 Years) in the PPE Population in Study 001 by Vaccination Group
| Endpoint | 9vHPV Vaccine (N = 856) | qHPV Vaccine (N = 857) | Vaccine Efficacy (95% CI)% | ||
|---|---|---|---|---|---|
| Cases / n | Rate | Cases / n | Rate | ||
| HPV-31/33/45/52/58–related persistent infection ≥6 months durationa | 3 / 736 | 13.1 | 67 / 739 | 309.1 | 95.8 (87.8–98.9) |
| By country | |||||
| Hong Kong/Taiwanb | 0 / 291 | 0.0 | 17 / 300 | 202.1 | 100 (78.2–100) |
| Japan | 2 / 112 | 55.1 | 20 / 117 | 575.7 | 90.4 (62.4–98.4) |
| South Korea | 0 / 124 | 0.0 | 11 / 113 | 354.0 | 100 (71.2–100) |
| Thailand | 1 / 209 | 14.5 | 19 / 209 | 284.2 | 94.9 (70.9–99.8) |
| By HPV type | |||||
| HPV-31–related | 0 / 712 | 0.0 | 7 / 702 | 32.5 | 100 (41.0–100) |
| HPV-33–related | 0 / 707 | 0.0 | 8 / 716 | 36.4 | 100 (46.5–100) |
| HPV-45–related | 0 / 726 | 0.0 | 1 / 725 | 4.5 | 100 (≤−999 to 100) |
| HPV-52–related | 3 / 652 | 14.8 | 33 / 644 | 169.0 | 91.3 (74.5–97.7) |
| HPV-58–related | 0 / 666 | 0.0 | 25 / 685 | 120.1 | 100 (86.3–100) |
| HPV-31/33/45/52/58–related persistent infection ≥12 months durationc | 3 / 736 | 13.1 | 47 / 739 | 214.1 | 93.9 (81.4–98.4) |
| By HPV type | |||||
| HPV-31–related | 0 / 712 | 0.0 | 5 / 702 | 23.2 | 100 (2.5–100) |
| HPV-33–related | 0 / 707 | 0.0 | 8 / 716 | 36.4 | 100 (46.5–100) |
| HPV-45–related | 0 / 726 | 0.0 | 1 / 725 | 4.5 | 100 (≤−999 to 100) |
| HPV-52–related | 3 / 652 | 14.8 | 24 / 644 | 122.0 | 87.9 (61.1–96.9) |
| HPV-58–related | 0 / 666 | 0.0 | 11 / 685 | 52.3 | 100 (66.5–100) |
| HPV-31/33/45/52/58–related cervical, vulvar, and vaginal disease (any grade) | 0 / 751 | 0.0 | 7 / 745 | 29.4 | 100 (40.0–100) |
| By HPV type | |||||
| HPV-31–related | 0 / 726 | 0.0 | 0 / 710 | 0.0 | NA |
| HPV-33–related | 0 / 720 | 0.0 | 2 / 722 | 8.7 | 100 (−248.2 to 100) |
| HPV-45–related | 0 / 740 | 0.0 | 0 / 733 | 0.0 | NA |
| HPV-52–related | 0 / 662 | 0.0 | 4 / 650 | 19.2 | 100 (−10.1 to 100) |
| HPV-58–related | 0 / 676 | 0.0 | 1 / 689 | 4.5 | 100 (≤−999 to 100) |
| By lesion type | |||||
| HPV-31/33/45/52/58–related cervical disease (any grade) | 0 / 738 | 0.0 | 7 / 737 | 30.5 | 100 (39.7–100) |
| CIN 1 | 0 / 738 | 0.0 | 6 / 737 | 26.2 | 100 (33.0–100) |
| CIN 2/3, AIS, and cervical cancer | 0 / 738 | 0.0 | 1 / 737 | 4.3 | 100 (≤−999 to 100) |
| HPV-31/33/45/52/58–related vulvar and vaginal disease (any grade) | 0 / 751 | 0.0 | 0 / 745 | 0.0 | NA |
| HPV-31/33/45/52/58–related ASC-US HR-HPV positive or worse | 2 / 731 | 8.8 | 25 / 729 | 111.5 | 92.1 (71.5–98.7) |
| By HPV type | |||||
| HPV-31–related | 0 / 708 | 0.0 | 3 / 694 | 13.9 | 100 (−68.3 to 100) |
| HPV-33–related | 0 / 703 | 0.0 | 3 / 708 | 13.6 | 100 (−72.8 to 100) |
| HPV-45–related | 0 / 722 | 0.0 | 2 / 717 | 9.0 | 100 (−245.6 to 100) |
| HPV-52–related | 1 / 649 | 4.9 | 15 / 638 | 75.6 | 93.5 (58.4–99.7) |
| HPV-58–related | 1 / 662 | 4.8 | 9 / 678 | 42.8 | 88.7 (18.8–99.5) |
| By lesion type | |||||
| ASC-US HR-HPV positive | 1 / 731 | 4.4 | 12 / 729 | 53.0 | 91.7 (51.5–99.6) |
| Low-grade squamous intraepithelial lesion | 1 / 731 | 4.4 | 19 / 729 | 84.5 | 94.8 (70.3–99.7) |
| High-grade squamous intraepithelial lesion or worsed | 0 / 731 | 0.0 | 2 / 729 | 8.8 | 100 (−247.0 to 100) |
| HPV-31/33/45/52/58–related cervical biopsy | 0 / 750 | 0.0 | 15 / 745 | 63.8 | 100 (73.4–100) |
| By HPV type | |||||
| HPV-31–related | 0 / 725 | 0.0 | 0 / 710 | 0.0 | NA |
| HPV-33–related | 0 / 719 | 0.0 | 2 / 722 | 8.7 | 100 (−248.5 to 100) |
| HPV-45–related | 0 / 739 | 0.0 | 0 / 733 | 0.0 | NA |
| HPV-52–related | 0 / 661 | 0.0 | 11 / 650 | 53.3 | 100 (67.3–100) |
| HPV-58–related | 0 / 675 | 0.0 | 3 / 689 | 13.7 | 100 (−74.7 to 100) |
| HPV-31/33/45/52/58–related cervical definitive therapy | 0 / 750 | 0.0 | 0 / 745 | 0.0 | NA |
| HPV-31/33/45/52/58–related external genital procedures | 0 / 751 | 0.0 | 0 / 745 | 0.0 | NA |
The PPE population consisted of participants who received all 3 doses of vaccine within 1 year, were seronegative at day 1, and had negative results on PCR assays for all HPV types tested from day 1 through month 7 to the vaccine HPV type being analyzed, and had no protocol violations that could interfere with the evaluation of vaccine efficacy as judged by the study director.
Participants are counted once in each applicable endpoint category. A participant may appear in more than 1 category. Rate is the estimate of number of cases per 10000 person-years.
Abbreviations: 9vHPV, 9-valent human papillomavirus; AIS, adenocarcinoma in situ; ASC-US, atypical squamous cells of undetermined significance; CI, confidence interval; CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; HR, high risk; NA, not available (ie, not calculable); PCR, polymerase chain reaction; PPE, per-protocol efficacy; qHPV, quadrivalent human papillomavirus.
N = number of participants randomized to the respective vaccination group who received at least 1 injection. n = number of participants who have at least 1 follow-up visit after month 7.
aA case of persistent infection occurred if a participant, after completion of the month 7 visit, is positive for the same HPV type by the HPV-31/33/45/52/58 PCR assay to at least 1 common gene in 2 or more consecutive cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained at 2 or more consecutive visits at least 6 months (± 1 month visit windows) apart.
bResults for participants from Taiwan only are 0/216 and 13/228 cases in the 9vHPV and qHPV vaccine groups, respectively, representing an efficacy of 100% (95% CI, 71.7–100).
cA case of persistent infection occurred if a participant, after completion of the month 7 visit, is positive for the same HPV type by the HPV-31/33/45/52/58 PCR assay to at least 1 common gene in 2 or more consecutive cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained for over a period of at least 12 months (± 1 month visit windows) apart.
dIncludes high-grade squamous intraepithelial lesion; atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion; atypical glandular cells, adenocarcinoma, and squamous cell carcinoma.