Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10-14 years

Abstract

The human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine has been demonstrated to be highly efficacious and immunogenic with a favorable safety profile. This study assessed the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Korean girls aged 10-14 yr. This multi-center, observer-blind trial randomly assigned 321 healthy girls to receive three doses (0, 1, 6-month schedule) of HPV-16/18 AS04-adjuvanted vaccine or hepatitis A vaccine. Immunogenicity against vaccine antigens was assessed one month post-Dose 3. Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded. In the according-to-protocol analysis, all initially seronegative subjects vaccinated with the HPV-16/18 AS04-adjuvanted vaccine had seroconverted at Month 7, with a peak geometric mean titer (GMT) that was 600-fold higher than the natural infection titer of 29.8 EU/mL for HPV-16 and a peak GMT that was 400-fold higher than the natural infection titer of 22.6 EU/mL for HPV-18. The vaccine was well tolerated with no increase in reactogenicity with subsequent doses and no reports of vaccine-related SAEs. In conclusion, the HPV-16/18 AS04-adjuvanted vaccine is shown to be highly immunogenic and generally well-tolerated in Korean girls aged 10-14 yr.

Keywords: AS04-adjuvanted; Adolescent; HPV-16/18; Human papillomavirus; Immunogenicity; Prophylactic Vaccine; Safety; Uterine Cervical Neoplasms; VLP.

Fig. 1

Trial profile. This study recruited and randomized 321 healthy Korean girls aged 10-14 yr and they received at least one dose of the HPV-16/18 AS04-adjuvanted vaccine or the hepatitis A vaccine. A total of 319 girls completed the study. The parents of two subjects in the HPV-16/18 group withdrew their consent which was not due to adverse events. Eligibility criterion for the ATP safety analysis was met for 258 participants and after further exclusions 248 subjects met the eligibility criteria for the ATP immunogenicity analysis. ^*, 18 subjects in total, but one subject was already excluded for administration of protocol-forbidden vaccine. n, Number of subjects.