Dataset Information

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.

SUBMITTER: Kim YJ

PROVIDER: S-EPMC2908791 | biostudies-literature | 2010 Aug

REPOSITORIES: biostudies-literature

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

Kim Young-Jae YJ Kim Kyung-Tai KT Kim Jae-Hoon JH Cha Soon-Do SD Kim Jae Weon JW Bae Duk-Soo DS Nam Joo-Hyun JH Ahn Woong-Shick WS Choi Ho-Sun HS Ng Timothy T Bi Dan D OK Jin-Ju JJ Descamps Dominique D Bock Hans L HL

Journal of Korean medical science 20100721 8

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. Immunogenici ...[more]

PMID: 20676333

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Project description:This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of 2 doses of the HPV-16/18 AS04-adjuvanted vaccine (HPV-16/18(2D)) vs. 2 or 3 doses of the HPV-6/11/16/18 vaccine (HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D)) in healthy girls aged 9-14 y. Girls were randomized (1:1:1) to receive HPV-16/18(2D) at months (M) 0,6 (N = 359), HPV-6/11/16/18(2D) at M0,6 (N = 358) or HPV-6/11/16/18(3D) at M0,2,6 (N = 358). The primary objective was non-inferiority/superiority of HPV-16/18 antibodies by ELISA for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) at M7 in the according-to-protocol immunogenicity cohort (ATP-I) and total vaccinated cohort, respectively. Secondary objectives included non-inferiority/superiority of HPV-16/18(2D) vs. HPV-6/11/16/18(3D) at M7, non-inferiority/superiority at M12, HPV-16/18 neutralizing antibodies, frequencies of T-cells/B-cells, reactogenicity and safety. Antibody responses at M7 for HPV-16/18(2D) were superior to those for HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) (lower limit of 95% confidence interval for geometric mean titer ratio (GMR) was >1): HPV-16/18(2D)/HPV-6/11/16/18(2D) GMRs were 1.69 [1.49-1.91] for anti-HPV-16 and 4.52 [3.97-5.13] for anti-HPV-18; HPV-16/18(2D)/HPV-6/11/16/18(3D) GMRs were 1.72 [1.54-1.93] for anti-HPV-16 and 3.22 [2.82-3.68] for anti-HPV-18; p = 0.0001 for all comparisons. Non-inferiority/superiority was also demonstrated at M12. Among initially seronegative girls in the ATP-I, neutralizing antibody titers were at least 1.8-fold higher for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) at M7 and M12. Frequencies of HPV-16/18-specific T-cells and B-cells were in similar ranges between groups. Reactogenicity and safety were in line with the known profile of each vaccine. In conclusion, superior HPV-16/18 antibody responses were elicited by 2 doses of the HPV-16/18 AS04-adjuvanted vaccine compared with 2 or 3 doses of the HPV-6/11/16/18 vaccine in girls (9-14 years).

Project description:Since 2007, a Human Papillomavirus (HPV) vaccination programme against cervical cancer (CC) is implemented in Italy in 11-year-old girls. The extension of HPV vaccination to young adult women, or to 11-year-old boys could further reduce the CC burden, in the latter case from indirect effect on HPV transmission. The objective of the study was to compare the potential CC cases prevention from HPV-16/18 AS04-adjuvanted vaccination of adding catch-up targeting 15- or 25-year-old girls to the addition of boys vaccination in Italy. The models assessing the impact of these alternative vaccination strategies are usually dynamic models requiring numerous input data. Simpler models could however provide some insight into this question, as reported in the current study.A published cohort model adapted to the Italian setting was used to estimate the potential CC reduction following different HPV vaccination strategies with a HPV-16/18 AS04-adjuvanted vaccine: vaccination of 11-year-old girls, female aged 15 or 25 years. The model assumed that the maximum benefit obtained from vaccinating boys equals the CC reduction that would result from immunisation of all non-vaccinated girls of the same age. Each cohort of 11-year-olds (either girls or boys) was assumed to include 281,000 individuals and a 70% vaccination coverage was applied. Sensitivity analysis was performed by varying the vaccination coverage and the overlap in potential sexual contacts between vaccinated boys and girls of the same age-group.Under base case, compared with the screening-only scenario, HPV vaccination of 11-year-old girls, 15-year-old females, 25-year-old females or 11-year-old boys, would prevent 1,146, 1,082, 788 or 491 CC cases respectively. HPV vaccination of boys could result in more CC cases prevented than adding a female catch-up only in scenarios with low vaccination coverage in the primary target cohort and when combined with small overlap between vaccinated boys and girls of the same age cohort.For a fixed limited additional budget allowing the inclusion of a single catch-up cohort, the extension of HPV vaccination to girls or young women instead of boys was estimated to maximise the number of CC cases prevented.

Dataset Information

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

Publications

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

Similar Datasets

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