Efficacy of Human Papillomavirus Type 16/18 AS04-Adjuvanted Vaccine in Japanese Women Aged 20 to 25 Years: Final Analysis of a Phase 2 Double-Blind, Randomized Controlled Trial

Abstract

The HPV-16/18 AS04-adjuvanted vaccine showed excellent prophylactic efficacy against 6-month persistent infection with HPV-16/18. The HPV-16/18 AS04-adjuvanted vaccine was generally well tolerated and immunogenic in the study population of healthy Japanese women aged 20 to 25 years.

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

“…In other clinical trials and surveillance studies conducted in different countries such as Japan, the Netherlands and United Kingdom7, 8, 9, 10, 11, 12, 13, 14, 15, 24, 25, 26, 27, 28, 29, transient injection‐site pain lasting for less than 5 days 30 was consistently the most commonly occurring AE. The results of the present study now provide further evidence that the safety profile of the HPV‐16/18 AS04‐adjuvanted vaccine is similar when administered to women in Korea.…”

Prevalence and type distribution of human papillomavirus in healthy Japanese women aged 20 to 25 years old enrolled in a clinical study

“…We have recently reported the results of a clinical study to evaluate the bivalent HPV-16 ⁄ 18 AS04-adjuvanted vaccine (Cervarix Ò , GlaxoSmithKline Biologicals) in healthy Japanese women aged 20-25 years. (28)(29)(30) While the results of this study showed that the HPV-16 ⁄ 18 AS04-adjuvanted vaccine was effective and immunogenic, with a clinically acceptable safety profile in the population studied, an accurate knowledge of the actual HPV infection rates in young healthy Japanese women could further confirm the importance of vaccination against HPV types 16 and 18. We therefore determined the HPV infection status of each woman at study entry as an indicator of the national infection rates.…”

“…Inclusion and exclusion criteria were as previously described. (30) The study was conducted following the Declaration of Helsinki (version 1996) and all participants provided written informed consent. All recruitment materials, informed consent, protocol, and amendments were approved by independent institutional review boards.…”

“…Investigators obtained cervical specimens with a cervical brush for cytology and HPV DNA as previously described. (18,(28)(29)(30)(31) HPV DNA isolated from the cytology specimen was amplified from an aliquot of purified total DNA with the SPF 10 broadspectrum primers. These primers amplify a 65 bp region of the L1 gene and the generic amplification products were detected by hybridization on a microtiter plate (DEIA).…”

“…If a sample was negative for HPV-16 or HPV-18 by the SPF 10 -LiPA 25 system, type-specific PCR was performed to confirm the absence of these types using HPV-16 primers that amplified a 92 bp segment of the E6 ⁄ E7 gene and HPV-18 primers that amplified a 126 bp segment of the L1 gene. (18,(28)(29)(30)(31) Cytology was assessed by liquid-based cytology (ThinPrep, Cytyc Corporation, Marlborough, MA, USA) using a central lab-oratory (Quest Diagnostics, Teterboro, NJ, USA). Cytology results were reported using the 2001 Bethesda system and cytological abnormalities included: (i) ASC-US; (ii) LSIL; (iii) ASC-H; (iv) HSIL; and (v) AGC.…”