作者: Neerja Bhatla , Vanita Suri , Partha Basu , Surendra Shastri , Sanjoy K. Datta
DOI: 10.1111/J.1447-0756.2009.01167.X
关键词: Vaccination 、 Gynecology 、 Placebo 、 Multicenter trial 、 Medicine 、 Young adult 、 Cohort study 、 Cervical cancer 、 Confidence interval 、 Internal medicine 、 Adverse effect
摘要: Aim: India has the highest number of annual incident cases and mortality rates for cervical cancer worldwide. This study was conducted to assess immunogenicity safety human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in healthy Indian women aged 18–35 years old. Methods: double-blind, randomized (1:1), controlled multicenter trial with two parallel groups, Vaccine Placebo included 354 subjects four centers across India. Subjects were given GlaxoSmithKline's HPV-16/18 or aluminum hydroxide placebo according a 0, 1 6 month schedule followed up until month 7. Serum samples drawn at pre-vaccination Safety data collected throughout study. Results: A total 330 completed study. One post-Dose 3, all initially seronegative group had seroconverted HPV-16 HPV-18 antibodies anti-HPV-16 anti-HPV-18 geometric mean titer levels 10226.5 EL.U/ml (95% confidence interval: 8847.1–11821.0) 3953.0 3421.8–4566.8), respectively. Initially seropositive also showed an increase similar levels. Six serious adverse events (two group), unrelated vaccination, reported. Commonly reported solicited local (injection-site pain) general (fatigue, headache fever) symptoms both groups. Compliance three-dose vaccination course >97%. Conclusions: The highly immunogenic generally well-tolerated making it potential tool prevention control