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: 55.87). 06/2007; 356(19):1928-43. DOI: 10.1056/NEJMoa061760
Source: PubMed


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 [].).

Download full-text


Available from: Diane M Harper, Oct 05, 2015
24 Reads
  • Source
    • "HPV infection and its consequences are potentially preventable with an HPV vaccine [Palefsky et al., 2011]. The efficacy of the quadrivalent (4vHPV) vaccine (covers HPV 6, 11, 16, and 18) against cervical cancer or cervical intraepithelial neoplasia (CIN) among women aged 16–26 years was almost 100% [Garland et al., 2007]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: HPV DNA testing is receiving increasing popularity in cervical cancer screening. There is a lack of universal guidelines on HPV testing. Our study aimed to assess age-specific and year-on-year trend of HPV positivity and incidence and HPV retesting among 26,457 individual women attending the gynecological department at the First People's Hospital of Yunnan Province (FPHY) who had an HPV testing between January 1, 2012 and December 31, 2014. HPV types 16, 52, cp8304, 58 and 6 ranked top 5 with regard to positivity in each year and overall incidence. The positivity of various HPV types peaked among women aged 15-19 years, then sharply decreased with age, stabilized among women aged 25-49 years and then surged again among women aged 50 years and older. The positivity of high-risk(HR) HPV types, including HPV 16, 18, 31, 33, 56 and 58, were on the rise during the time period (p<0.05 for all). HR HPV types tended to be more likely to persist than LR HPV types (p<0.05). Additionally the incidence rate for any HR HPV type was also significantly higher than that for any LR HPV type (42.8 vs 12.6 per 100 person-years, p<0.001). The majority (57.3-77.5%) of women detected with HR HPV types did not retest within 12 months. Clinical guidelines on HPV DNA testing are needed and education, and counseling about HPV infection and its implications for women detected with HPV at clinical settings, are warranted.
    Journal of Medical Virology 09/2015; DOI:10.1002/jmv.24377 · 2.35 Impact Factor
  • Source
    • "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]. "
    [Show abstract] [Hide abstract]
    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 · 3.62 Impact Factor
  • Source
    • "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. "
    [Show abstract] [Hide abstract]
    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 · 3.62 Impact Factor
Show more