Immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in healthy boys aged 10-18 years.

摘要: Abstract Purpose The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine ( Cervarix ™) has been shown to be well-tolerated and immunogenic in females aged 10 55 years, up 100% effective for the prevention of HPV-16/18 infection associated precancerous cervical lesions 15 25 years. This study is first evaluate immunogenicity safety males. Methods Healthy males 18 years were randomized (2:1 ratio) receive (n = 181) or hepatitis B virus (HBV) control 89) at 0, 1, 6 months, followed 7 months. Results All initially seronegative subjects group seroconverted HPV-16 (ELISA) month 2. At 7, all seropositive, -18 antibody levels were, respectively, four- twofold higher than anti-HPV-16 responses 14 those reported a previous study. reactogenicity profiles AS04 HBV vaccines similar, except that pain swelling injection site more common group. However, vaccine-related symptoms did not affect compliance with three-dose course, which was equally high (97%) both groups. Conclusions well tolerated boys further data on potential public health benefits vaccination are required before any recommendations can made.