Table 1.
Analysis of 9vHPV vaccine effectiveness against HPV16/18/31/33/45/52/58-related CIN2, CIN3, AIS, and cervical cancer by time since 9vHPV vaccination, HPV type, and lesion type (PPE population).a.
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Young women 16–26 years of age (N = 2029) |
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|---|---|---|---|---|
| Cases/n | Person-years’ follow-up | Rate per 100,000 person-years (95% CI) | Vaccine effectiveness,b % (95% CI) | |
| From the start of the LTFU study | ||||
| HPV16/18/31/33/45/52/58-related CIN2 or worsec | 0/1448 | 4084.2 | 0.0 (0.0–90.3) | 100 (79.4–100) |
| By time since start of the LTFU study | ||||
| >0 to 2 yearsd | 0/1448 | 2682.5 | 0.0 (0.0–137.5) | |
| >2 to 4 yearsd | 0/1094 | 1351.0 | 0.0 (0.0–273.1) | |
| >4 to 6 yearsd | 0/194 | 50.8 | 0.0 (0.0–7266.3) | |
| From the start of the base study | ||||
| HPV16/18/31/33/45/52/58-related CIN2 or worsee | 1/1783 | 10,303.1 | 9.7 (0.2–54.1) | |
| By time since 9vHPV vaccine Dose 1 | ||||
| ≤4 yearsf | 1/1783 | 5938.6 | 16.8 (0.4–93.8) | |
| >4 to 6 yearsd | 0/1586 | 2767.0 | 0.0 (0.0–133.3) | |
| >6 to 8 yearsd | 0/1147 | 1488.0 | 0.0 (0.0–247.9) | |
| >8 to 10 yearsd | 0/271 | 109.5 | 0.0 (0.0–3370.0) | |
| By HPV type | ||||
| HPV16-related | 0/1391 | 8128.6 | 0.0 (0.0–45.4) | |
| HPV18-related | 1/1564 | 9059.2 | 11.0 (0.3–61.5) | |
| HPV31-related | 0/1541 | 8981.7 | 0.0 (0.0–41.1) | |
| HPV33-related | 0/1604 | 9338.6 | 0.0 (0.0–39.5) | |
| HPV45-related | 0/1685 | 9752.9 | 0.0 (0.0–37.8) | |
| HPV52-related | 0/1583 | 9156.9 | 0.0 (0.0–40.3) | |
| HPV58-related | 0/1627 | 9464.0 | 0.0 (0.0–39.0) | |
| By lesion type | ||||
| CIN2 or CIN3 | 1/1783 | 10,302.9 | 9.7 (0.2–54.1) | |
| CIN2 | 1/1783 | 10,291.6 | 9.7 (0.2–54.1) | |
| CIN3 | 0/1783 | 10,301.2 | 0.0 (0.0–35.8) | |
| AIS | 0/1783 | 10,303.5 | 0.0 (0.0–35.8) | |
| Cervical cancer | 0/1783 | 10,303.5 | 0.0 (0.0–35.8) | |
N = number of participants who received at least one dose of the 9vHPV vaccine and consented to effectiveness follow-up.
n = number of PPE-eligible participants who have at least one follow-up visit. During the LTFU study, a follow-up visit represents retrieval of a cervical cytology or cervical, vulvar, or vaginal tissue sample collection record from the relevant national health registry.
aThe PPE population included participants who received all three doses of vaccine within 1 year, were seronegative at Day 1 and PCR-negative from Day 1 to Month 7 of the base study for the HPV type being analyzed, and had no protocol violations that could affect the evaluation of vaccine prophylactic efficacy.
bVaccine effectiveness measures the relative reduction of the disease incidence in vaccine recipients compared with a background incidence rate of 438 per 100,000 person-years, based on the incidence in an unvaccinated cohort.
cFor an individual participant, total person-years’ follow-up was calculated as the number of years starting from the beginning of the LTFU study (either the date when the participant reached the base study Year 4 or exited from the base study, whichever was later) through the date of the participant’s latest cervical cytology or cervical, vulvar, or vaginal tissue sample collection record obtained from the relevant national health registry.
dFor an individual participant with cervical cytology or cervical, vulvar, or vaginal tissue sample collection record obtained from the relevant national health registry within the indicated time interval, total person-years’ follow-up was calculated as the number of years starting from the date when the participant reached the beginning of the indicated time interval through either the date when the participant reached the end of the indicated time interval or the date of the participant’s latest cervical cytology or cervical, vulvar, or vaginal tissue sample collection record obtained from the relevant national health registry, whichever is earlier.
eFor an individual participant, total person-years’ follow-up was calculated as the number of years starting from the date when the participant reached Month 7 of the base study (the case counting start time in the per-protocol efficacy population) through the date of the participant’s latest cervical cytology or cervical, vulvar, or vaginal tissue sample collection record obtained from the relevant national health registry.
fThis time interval covers the base study period. For an individual participant, total person-years’ follow-up was calculated as the number of years starting from the date when the participant reached Month 7 of the base study through either the date when the participant reached the base study Year 4 or exited the base study, whichever is earlier.
9vHPV, nine-valent human papillomavirus; AIS, adenocarcinoma in situ; CI, confidence interval; CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus;LTFU, long-term follow-up; PCR, polymerase chain reaction; PPE, per-protocol effectiveness.