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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-adjuvanted 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.

japanese journal of clinical oncology

Safety and Immunogenicity Profile of Human Papillomavirus-16/18 AS04 Adjuvant Cervical Cancer Vaccine: A Randomized Controlled Trial in Healthy Adolescent Girls of Bangladesh