Safety and immunogenicity profile of human papillomavirus-16/18 AS04 adjuvant cervical cancer vaccine: a randomized controlled trial in healthy adolescent girls of Bangladesh

Aim: Bangladesh has the highest level of incidence and mortality rates due to cervical cancer among women. The prevalence of cervical cancer in Bangladeshi women is 25–30/100 000. Human papillomavirus is an important cause of cervical cancer. The study was conducted to assess the immunogenicity and safety profile of human papillomavirus-16/18 AS04-adju-vanted cervical cancer vaccines in healthy Bangladeshi girls aged 9–13 years. Procedure: This was a randomized (3:1) controlled trial with two parallel groups, the vaccine and control groups, that included 67 participants in Bangladesh. Subjects were given GlaxoSmithKline human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine (and controls no vaccine) at the first day of vaccination (Day 0), at 1- and 6-month schedule and followed up until 7 months. Blood samples were taken for human papillomavirus antibody at enrollment and 1 month post-schedule at Month 7 from both subjects and controls. Safety data were gathered throughout the study period. Results: Fifty subjects received vaccine at Day 0, 1 month and 6 months. All subjects were initially sero-negative in the vaccine group, and developed sero-conversion for human papillomavirus-16 and-18 antibodies except for one at Month 7. Seventeen controls di