Kavita Nanda, MD, MHS
Does an AS04-adjuvanted vaccine against human papillomavirus (HPV) 16/18 prevent cervical intraepithelial neoplasia (CIN) grade 2+ in young women?
Randomized controlled trial (PApilloma TRIal against Cancer In young Adults [PATRICIA]). ClinicalTrials.gov NCT00122681.
Blinded (participants, clinicians, data collectors, outcome assessors, data analysts, and safety committee).*
Mean 39 months (maximum 48 mo).
135 centers in 14 countries in Pacific Asia, Europe, Latin America, and North America.
18 729 healthy women 15 to 25 years of age (mean age 20 y), regardless of HPV DNA status, HPV serostatus, or cervical cytology. Exclusion criteria included > 6 lifetime sexual partners, previous colposcopy, chronic or autoimmune disease, immunodeficiency, and current pregnancy or breast-feeding.
HPV-16/18 AS04-adjuvanted vaccine (n = 9319) or hepatitis A vaccine (n = 9325) at 0, 1, and 6 months.
CIN2+ and CIN3+ associated with HPV-16/18 or other oncogenic HPV types.
90% of women were still active in the trial at the time of analysis. 99.5% were included in the intention-to-treat (ITT) cohort, 86% in the per-protocol cohort, and 62% in the HPV-naïve cohort.
In the ITT cohort, vaccine efficacy was 53% (96.1% CI 38 to 65) against CIN2+ and 34% (CI −1 to 57) against CIN3+ associated with HPV-16/18. The vaccine was protective in women who were DNA-negative for the corresponding HPV type at baseline (Table) but not in those who were DNA-positive. The vaccine also protected against CIN2+ associated with other oncogenic HPV types.
An AS04-adjuvanted vaccine against human papillomavirus 16/18 prevented cervical intraepithelial neoplasia in young women.
Human papillomavirus (HPV) 16/18 AS04-adjuvanted vaccine vs hepatitis A vaccine (control) in young women†
†CIN = cervical intraepithelial neoplasm; CI defined in Glossary.
‡PP = per protocol (women who received 3 vaccine doses, had no protocol violation, and had normal or low-grade cervical cytology at baseline). This cohort was also seronegative at baseline and DNA-negative at months 0 and 6 for corresponding HPV type.
§M-ITT = modified intention-to-treat (women who received ≥ 1 vaccine dose). This cohort was also seronegative and DNA-negative at baseline for corresponding HPV type with normal or low-grade cytology.
||This cohort included women who received ≥ 1 dose and, at baseline, had normal cytology, were DNA-negative for all 14 oncogenic HPV types, and were seronegative for HPV-16 and HPV-18.
Nanda K. Human papillomavirus 16/18 AS04-adjuvanted vaccine prevented cervical intraepithelial neoplasia in young women. Ann Intern Med. ;151:JC6–6. doi: 10.7326/0003-4819-151-12-200912150-02006
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Published: Ann Intern Med. 2009;151(12):JC6-6.
Infectious Disease, Prevention/Screening, Vaccines/Immunization.
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