Table 3.
Incidence of non-9vHPV vaccine HPV type (35/39/51/56/59)-related persistent infection and disease in vaccinated participants (PPE populationa).
| Females (N = 971) |
Males (N = 301) |
|||||
|---|---|---|---|---|---|---|
| Cases/n | Person-years follow-upb | Rate per 10,000 person-years (95% CI) | Cases/n | Person-years follow-upb | Rate per 10,000 person-years (95% CI) | |
| HPV35/39/51/56/59-related 6-month persistent infectionc or diseased | 189/792 | 2280.2 | 828.9 (714.9–955.8) | 20/236 | 738.9 | 270.7 (165.3–418.0) |
| HPV35/39/51/56/59-related 6-month persistent infectionc | 189/792 | 2280.2 | 828.9 (714.9–955.8) | 20/236 | 738.9 | 270.7 (165.3–418.0) |
| By HPV type | ||||||
| HPV35 | 12/791 | 2635.4 | 45.5 (23.5–79.5) | 1/236 | 765.6 | 13.1 (0.3–72.8) |
| HPV39 | 59/782 | 2512.7 | 234.8 (178.7–302.9) | 3/236 | 767.1 | 39.1 (8.1–114.3) |
| HPV51 | 76/782 | 2485.1 | 305.8 (240.9–382.8) | 5/236 | 764.2 | 65.4 (21.2–152.7) |
| HPV56 | 101/782 | 2422.9 | 416.9 (339.5–506.5) | 11/235 | 744.8 | 147.7 (73.7–264.2) |
| HPV59 | 51/785 | 2539.8 | 200.8 (149.5–264.0) | 3/236 | 763.4 | 39.3 (8.1–114.9) |
| HPV35/39/51/56/59-related 12-month persistent infectione | 106/792 | 2410.7 | 439.7 (360.0–531.8) | 8/236 | 751.3 | 106.5 (46.0–209.8) |
| By HPV type | ||||||
| HPV35 | 7/791 | 2639.5 | 26.5 (10.7–54.6) | 1/236 | 765.6 | 13.1 (0.3–72.8) |
| HPV39 | 28/784 | 2554.4 | 109.6 (72.8–158.4) | 0/236 | 768.6 | 0.0 (0.0–48.0) |
| HPV51 | 29/789 | 2577.0 | 112.5 (75.4–161.6) | 1/236 | 767.1 | 13.0 (0.3–72.6) |
| HPV56 | 49/786 | 2523.2 | 194.2 (143.7–256.7) | 5/235 | 753.1 | 66.4 (21.6–154.9) |
| HPV59 | 27/789 | 2588.9 | 104.3 (68.7–151.7) | 2/236 | 765.1 | 26.1 (3.2–94.4) |
| HPV35/39/51/56/59-related diseased | 11/792 | 2639.2 | 41.7 (20.8–74.6) | 0/236 | 768.6 | 0.0 (0.0–48.0) |
| CIN1f | 9/792 | 2642.7 | 34.1 (15.6–64.6) | – | – | – |
| CIN2 or CIN3f | 2/792 | 2655.5 | 7.5 (0.9–27.2) | – | – | – |
| AISf | 0/792 | 2657.8 | 0.0 (0.0–13.9) | – | – | – |
| Cervical cancerf | 0/792 | 2657.8 | 0.0 (0.0–13.9) | – | – | – |
| Condyloma | 0/792 | 2657.8 | 0.0 (0.0–13.9) | 0/236 | 768.6 | 0.0 (0.0–48.0) |
| VIN1 or worsef,g | 1/792g | 2655.0 | 3.8 (0.1–21.0) | – | – | – |
| VaIN1 or worsef,h | 1/792h | 2655.0 | 3.8 (0.1–21.0) | – | – | – |
| PIN1 or worsei | – | – | – | 0/236 | 768.6 | 0.0 (0.0–48.0) |
Abbreviations: AIS = adenocarcinoma in situ; CI = confidence interval; CIN = cervical intraepithelial neoplasia; HPV = human papillomavirus; PCR = polymerase chain reaction; PIN = penile intraepithelial neoplasia; PPE = per-protocol effectiveness; VaIN = vaginal intraepithelial neoplasia; VIN = vulvar intraepithelial neoplasia.
A baseline HPV-naïve population with respect to HPV types 35/39/51/56/59 cannot be defined in this study due to the absence of baseline sero- and PCR-status with respect to these non-vaccine HPV types. As such, a baseline HPV-naïve population with respect to these HPV types is approximated by the population of subjects who were naïve for all of HPV types 6/11/16/18/31/33/45/52/58. The PPE population for the non-vaccine HPV types 35/39/51/56/59 is comprised of subjects who were PPE-eligible for all of HPV types 6/11/16/18/31/33/45/52/58.
For each participant, person-years of follow-up was calculated starting from the beginning of the LTFU study (i.e. month 42 visit) or the date when the participant reached age 16 years, whichever came later.
A case of 6-month persistent infection is a participant who is positive to ≥1 common gene for the same HPV type in the HPV35/39/51/56/59 PCR assay in two or more cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained at two or more consecutive visits at least 6 months (±1 month) apart.
In females, disease includes condyloma, CIN, AIS, VIN, VaIN, and cervical/vulvar/vaginal cancer; in males, this includes condyloma, PIN, and penile/perineal/perianal cancer.
A case of 12-month persistent infection is a participant who is positive to ≥1 common gene for the same HPV type in the HPV35/39/51/56/59 PCR assay in two or more cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained at three or more consecutive visits at least 6 months (±1 month) apart.
In female participants.
Case of VIN 1.
Case of VaIN 1.
In male participants.