子宮頚癌に関連したHPV-16 と HPV-18 の２種類のウイルスの予防効果のあるワクチンである。15-25才の約800人を、Cervarixワクチン接種393人とプラセーボ383人のにたいし、6ヶ月ごとに6.4年にわたりHPV DNAの検査を施行した。12ヶ月後には100%の予防効果があり、自然感染による抗体価上昇よりも少なくとも数倍の抗体価を維持できた。子宮頚癌の10%の原因となっているHPV-31とHPV-45による感染に対しても予防効果があるという。
Cervarix Proves Effective Against HPV for Over 6 Years
Vaccine protected volunteers from virus linked to cervical cancer
-- Robert Preidt
WEDNESDAY, Dec. 2 (HealthDay News) -- The human papillomavirus (HPV) vaccine Cervarix protects women from infection for longer than six years, new research has found.
The vaccine guards against the two types of HPV (HPV-16 and HPV-18) most commonly associated with cervical cancer.
The study looked at nearly 800 women, aged 15 to 25, with a normal cervical profile and no evidence of HPV infection at the start of the trial. There were 393 women who received the Cervarix vaccine and 383 who received an inactive placebo. Every six months for 6.4 years, the women were tested for HPV DNA.
The researchers found that vaccine efficacy against 12-month persistent infection with HPV-16/18 remained 100 percent during the study period. Vaccine efficacy against incident infection with HPV-16/18 was 95 percent. Antibody concentrations against HPV-16/18 in vaccinated women remained at least several-fold higher than would be found after natural HPV infection, the study authors noted.
Cervarix also protected women against incident infection with HPV-31 and HPV-45, which "are among the types most frequently associated with cervical cancer after HPV-16 and HPV-18, and are responsible for 10 percent of all cervical cancer cases," wrote Dr. Cosette Wheeler, of the Health Sciences Center at the University of New Mexico, and colleagues.
The study was released online Dec. 2 in advance of publication in an upcoming print issue of The Lancet.
"Although further assessment is necessary to confirm long-term vaccine effects, in view of the data from our study, we expect protection to continue for many more years," the researchers concluded.
Cervarix, from GlaxoSmithKline, received U.S. Food and Drug Administration approval in October.
The U.S. National Cancer Institute has more about HPV vaccines.
SOURCE: The Lancet, news release, Dec. 2, 2009
Copyright (c) 2009 ScoutNews, LLC. All rights reserved.
The Lancet, Early Online Publication, 3 December 2009
doi:10.1016/S0140-6736(09)61567-1Cite or Link Using DOI
Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years
The GlaxoSmithKline Vaccine HPV-007 Study Group‡
Prophylactic human papillomavirus (HPV) vaccines have to provide sustained protection. We assessed efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine up to 6?4 years.
Women aged 15―25 years, with normal cervical cytology, who were HPV-16/18 seronegative and oncogenic HPV DNA-negative (14 types) at screening participated in a double-blind, randomised, placebo-controlled initial study (n=1113; 560 vaccine group vs 553 placebo group) and follow-up study (n=776; 393 vs 383). 27 sites in three countries participated in the follow-up study. Cervical samples were tested every 6 months for HPV DNA. Management of abnormal cytologies was prespecified, and HPV-16/18 antibody titres were assessed. The primary objective was to assess long-term vaccine efficacy in the prevention of incident cervical infection with HPV 16 or HPV 18, or both. We report the analyses up to 6?4 years of this follow-up study and combined with the initial study. For the primary endpoint, the efficacy analysis was done in the according-to-protocol (ATP) cohort; the analysis of cervical intraepithelial neoplasia grade 2 and above (CIN2+) was done in the total vaccinated cohort (TVC). The study is registered with ClinicalTrials.gov, number NCT00120848.
For the combined analysis of the initial and follow-up studies, the ATP efficacy cohort included 465 women in the vaccine group and 454 in the placebo group; the TVC included 560 women in the vaccine group and 553 in the placebo group. Vaccine efficacy against incident infection with HPV 16/18 was 95?3% (95% CI 87?4―98?7) and against 12-month persistent infection was 100% (81?8―100). Vaccine efficacy against CIN2+ was 100% (51?3―100) for lesions associated with HPV-16/18 and 71?9% (20?6―91?9) for lesions independent of HPV DNA. Antibody concentrations by ELISA remained 12-fold or more higher than after natural infection (both antigens). Safety outcomes were similar between groups: during the follow-up study, 30 (8%) participants reported a serious adverse event in the vaccine group versus 37 (10%) in the placebo group. None was judged related or possibly related to vaccination, and no deaths occurred.
Our findings show excellent long-term efficacy, high and sustained immunogenicity, and favourable safety of the HPV-16/18 AS04-adjuvanted vaccine up to 6?4 years.
GlaxoSmithKline Biologicals (Belgium).
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