Brian Budenholzer, MD, FAAFP
Does an AS04-adjuvanted vaccine against human papillomavirus (HPV) 16/18 prevent cervical intraepithelial neoplasia grade 3 or worse (CIN3+) or adenocarcinoma in situ (AIS) in young women?
Randomized controlled trial (RCT) (PApilloma TRIal against Cancer In young Adults [PATRICIA]). ClinicalTrials.gov NCT00122681.
Blinded* (participants, clinicians, and outcome assessors).
4 years (mean 44 mo).
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). Exclusion criteria for participants outside of Finland included > 6 lifetime sexual partners.
HPV-16/18 AS04-adjuvanted vaccine (n = 9319) or control hepatitis A vaccine (n = 9325) at 0, 1, and 6 months.
CIN3+ and AIS regardless of HPV DNA status, and CIN3+ and AIS associated with HPV-16 and/or HPV-18.
83% completed the study. 93% were included in the modified intention-to-treat analysis and 58% in the HPV-naïve cohort analysis.
The main results are in the Table.
An AS04-adjuvanted vaccine against human papillomavirus 16/18 prevented cervical intraepithelial neoplasia grade 3 or worse and adenocarcinoma in situ in young women.
HPV-16/18 AS04-adjuvanted vaccine vs hepatitis A vaccine (control) in young women†
†AIS = adenocarcinoma in situ; CIN3+ = cervical intraepithelial neoplasia grade 3 or worse; HPV = human papillomavirus; mITT = modified intention-to-treat; NR = not reported; other abbreviations defined in Glossary.
‡Women who had ≥ 1 vaccine dose and were evaluable for efficacy.
§Women who had ≥ 1 vaccine dose; were evaluable for efficacy; and were HPV DNA–negative at baseline for all 14 HPV types tested, seronegative for HPV-16 and HPV-18, and had negative cytology.
Budenholzer B. HPV-16/18 AS04-adjuvanted vaccine prevented cervical intraepithelial neoplasia ≥ grade 3 in young women. Ann Intern Med. ;157:JC2–7. doi: 10.7326/0003-4819-157-2-201207170-02007
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Published: Ann Intern Med. 2012;157(2):JC2-7.
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