Quadrivalent Vaccine against Human Papillomavirus to Prevent Anogenital Diseases

Microbiology and Infectious Diseases Department, Royal Women's Hospital, and the University of Melbourne, Melbourne, Australia.
New England Journal of Medicine (Impact Factor: 54.42). 06/2007; 356(19):1928-43. DOI: 10.1056/NEJMoa061760
Source: PubMed

ABSTRACT A phase 3 trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine in preventing anogenital diseases associated with human papillomavirus (HPV) types 6, 11, 16, and 18.
In this randomized, placebo-controlled, double-blind trial involving 5455 women between the ages of 16 and 24 years, we assigned 2723 women to receive vaccine and 2732 to receive placebo at day 1, month 2, and month 6. The coprimary composite end points were the incidence of genital warts, vulvar or vaginal intraepithelial neoplasia, or cancer and the incidence of cervical intraepithelial neoplasia, adenocarcinoma in situ, or cancer associated with HPV type 6, 11, 16, or 18. Data for the primary analysis were collected for a per-protocol susceptible population of women who had no virologic evidence of HPV type 6, 11, 16, or 18 through 1 month after administration of the third dose.
The women were followed for an average of 3 years after administration of the first dose. In the per-protocol population, those followed for vulvar, vaginal, or perianal disease included 2261 women (83%) in the vaccine group and 2279 (83%) in the placebo group. Those followed for cervical disease included 2241 women (82%) in the vaccine group and 2258 (83%) in the placebo group. Vaccine efficacy was 100% for each of the coprimary end points. In an intention-to-treat analysis, including those with prevalent infection or disease caused by vaccine-type and non-vaccine-type HPV, vaccination reduced the rate of any vulvar or vaginal perianal lesions regardless of the causal HPV type by 34% (95% confidence interval [CI], 15 to 49), and the rate of cervical lesions regardless of the causal HPV type by 20% (95% CI, 8 to 31).
The quadrivalent vaccine significantly reduced the incidence of HPV-associated anogenital diseases in young women. ( number, NCT00092521 [].).

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Available from: Diane M Harper, Aug 09, 2015
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    • "Taking cultural differences into account, parental attitude toward HPV vaccination for boys and girls in China could be different in comparison to findings from other countries. HPV vaccines have been proved to be efficient in preventing HPV infection both in men and women [2] [3]. Therefore, the World Health Organization and the U. S. Centers for Disease Control and Prevention has recommended HPV vaccines for use in both young females and males before the onset of sexual activity [17] [18] [19]. "
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    ABSTRACT: To determine the level of awareness on human papillomavirus (HPV) vaccine and acceptance of HPV vaccination among parents of junior middle school students. A cross sectional survey employing cluster sampling was conducted in Jinan, Shandong Province of China in January of 2013. A total of 400 parents of junior middle school students participated in the questionnaire survey, among whom 360 (90%) completed valid questionnaires. About 22 (22.5%) parents had ever heard of HPV. Only one in ten (10.2%) knew about HPV vaccine. Parents willing to accept HPV vaccination for children accounted for 40.8%. Factors associated willing to accept HPV vaccination for children among parents were: female parent (AOR: 0.38, 95%CI: 0.21-0.67), having ever heard of HPV vaccine (AOR: 2.38, 95%CI: 1.01-5.60), thinking HPV vaccination should commence before sexual debut(AOR: 2.16, 95%CI: 1.21-3.85), thinking HPV vaccination should commence before 12 years old (AOR: 2.76, 95%CI: 1.02-7.46) or 13-15 years old (AOR: 4.75, 95%CI: 1.79-12.61), concern about suffering from cervical cancer and/or genital warts (AOR: 2.43, 95%CI: 1.31-4.50). About 60% of parents were in favor of future HPV vaccination promoting in China believing that HPV vaccine could efficiently prevent cervical cancer, anal cancer or genital warts, 37.4% of parents with expectation of governmental subsidy and price regulation. Parental awareness level of HPV vaccine and willingness to accept HPV vaccination for children was low. However, the general attitude of many participants toward future promoting of HPV vaccination in China was encouraging, particularly if certain expectations were met. Copyright © 2015. Published by Elsevier Ltd.
    Vaccine 04/2015; 33(22). DOI:10.1016/j.vaccine.2015.04.010 · 3.49 Impact Factor
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    • "The most commonly used HPV vaccine in high income countries (including Canada, the UK, the US and Australia) is the quadrivalent [1], which protects against HPV-16/18 (responsible for more than 70% of cervical cancers [2] and associated with other anogenital [3] [4] and head and neck cancers [5]) and HPV-6/11 (associated with more than 85% of anogenital warts [6]). Although vaccinating girls against HPV is expected to dramatically reduce the burden of HPV-associated diseases [7] [8] and to be highly cost-effective [9] [10] [11], it nevertheless imposes an important financial strain on immunisation budgets. In Canada, HPV vaccine 0264-410X/© 2014 The Authors. "
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    ABSTRACT: Background Recent evidence suggests that two doses of HPV vaccines may be as protective as three doses in the short-term. We estimated the incremental cost-effectiveness of two- and three-dose schedules of girls-only and girls & boys HPV vaccination programmes in Canada. Methods We used HPV-ADVISE, an individual-based transmission-dynamic model of multi-type HPV infection and diseases (anogenital warts, and cancers of the cervix, vulva, vagina, anus, penis and oropharynx). We conducted the analysis from the health payer perspective, with a 70-year time horizon and 3% discount rate, and performed extensive sensitivity analyses, including duration of vaccine protection and vaccine cost. Findings Assuming 80% coverage and a vaccine cost per dose of $85, two-dose girls-only vaccination (vs. no vaccination) produced cost/quality-adjusted life-year (QALY)-gained varying between $7900–24,300. The incremental cost-effectiveness ratio of giving the third dose to girls (vs. two doses) was below $40,000/QALY-gained when: (i) three doses provide longer protection than two doses and (ii) two-dose protection was shorter than 30 years. Vaccinating boys (with two or three doses) was not cost-effective (vs. girls-only vaccination) under most scenarios investigated. Interpretation Two-dose HPV vaccination is likely to be cost-effective if its duration of protection is at least 10 years. A third dose of HPV vaccine is unlikely to be cost-effective if two-dose duration of protection is longer than 30 years. Finally, two-dose girls & boys HPV vaccination is unlikely to be cost-effective unless the cost per dose for boys is substantially lower than the cost for girls.
    Vaccine 10/2014; 32(44). DOI:10.1016/j.vaccine.2014.07.099 · 3.49 Impact Factor
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    • "Since the introduction of HPV vaccines, there has been controversy about the importance of vaccinating adolescents and young women. The protection conferred by the vaccine is unquestionable [1] [2] [3]. However , some groups oppose vaccination, claiming that its use might predispose adolescents and young women to engage in sexual risk behavior, thereby increasing their risk of contracting sexually transmitted infections (STIs) and even HPV itself [4]. "
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    ABSTRACT: Objective To compare sexual behaviors and risk perception between young women vaccinated for HPV and unvaccinated Colombian women. Methods In a cross-sectional design study, 1436 women (231 adolescents, < 18 years; 1205 young women, 18–26 years) completed a self-administered questionnaire between May 2011 and March 2012 in Bogotá, Colombia. Data from vaccinated and unvaccinated women were compared by descriptive statistics and multivariate models. Results Sexual risk behaviors were not associated with vaccination after adjustment for risk perception, age, educational level, and HPV knowledge. By contrast, vaccination was associated with higher routine Pap smear screening (odds ratio [OR], 2.35; 95% confidence interval [CI], 1.69–3.28), use of modern contraceptives (OR, 2.02; 95% CI, 1.26–3.22), and consistent use of condoms (OR, 1.49; 95% CI, 1.11–2.01). Vaccinated young women were more likely to have had sex (OR, 2.08; 95% CI, 1.56–2.78), but sexual debut among adolescents was not associated with vaccination. In bivariate and multivariate analyses, vaccination status was negatively associated with perceived risk of HPV infection, warts, and cervical cancer. There was no association between vaccination and perceived risk of sexually transmitted infections in any model. Conclusion No association was found between changes in risk perception after HPV vaccination and sexual risk behaviors.
    International Journal of Gynecology & Obstetrics 09/2014; 126(3). DOI:10.1016/j.ijgo.2014.03.033 · 1.56 Impact Factor
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