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1
Human papillomavirus (HPV) vaccine, Background paper, September 2008. Geneva, WHO, 2008 (http://www.who.int/immunization/documents/positionpapers/en/index.html; accessed 24 March 2009). 2 Human papillomavirus and HPV vaccines: technical information for policy-makers and health professionals. Geneva, WHO, 2007 (http://whqlibdoc.who.int/hq/2007/WHO_IVB_07.05_eng.pdf; accessed 25 September 2008). 3
Smith JS et al. Age-specific prevalence of infection with human papillomavirus in females: a global review. Journal of Adolescent Health, 2008, 43 (Suppl 4): S5.e1–S5.e62. 4 Ault KA, Future II Study Group. Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomized clinical trials. Lancet, 2007, 369:1861–1868. 5 Stanley M, Lowy DR, Frazer I. Prophylactic HPV vaccines: underlying mechanisms. Vaccine, 2006, 24(Suppl. 3):S106–S113. 6 Olsson SE et al. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine, 2007, 25:4931–4939. 7
Merck USA. Highlights of prescribing information: GARDASIL [human papillomavirus quadrivalent (Types 6, 11, 16, and 18) vaccine, Recombinant], 2008. Whitehouse Station, NJ, 2007 (http://www.merck.com/product/usa/pi_circulars/g/gardasil_pi.pdf; accessed 25 September 2008). 8 GlaxoSmithKline Australia. Cervarix® product information: human papillomavirus vaccine type 16 and 18 (Recombinant AS04 adjuvanted), 2007. Boronia, Victoria, Australia, 2007 (http://www.gsk.com.au/resources.ashx/vaccineproductschilddataproinfo/94/FileName/7A14FBAEA16635A2DD7A68ED78E8FDDC/P1_Cerva rix.pdf; accessed 15 May 2008). 9 Villa LL. Overview of the clinical development and results of a quadrivalent HPV (types 6, 11, 16, 18) vaccine. International Journal of Infectious Diseases, 2007, 11(Suppl 2):S17–S25. 10 Pedersen C et al. Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant. Journal of Adolescent Health, 2007, 40:564–571. 11 12
Pagliusi SR, Aguado MT. Efficacy and other milestones for human papillomavirus vaccine introduction. Vaccine, 2004, 23:569–578. FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. Journal of Infectious Diseases, 2007, 196:1438–1446. 13 Paavonen J et al. HPV PATRICIA study group. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet, 2007, 369:2161–2170. 14
Villa LL et al. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up. British Journal of Cancer, 2006, 95:1459–1466. 15 Smith JF et al. Antibodies from women immunized with Gardasil cross-neutralize HPV 45 pseudovirions. Human vaccines, 2007, 3:109–115. 16 Harper DM et al. Sustained immunogenicity and high efficacy against HPV 16/18 related cervical neoplasia: long-term follow-up through 6.4 years in women vaccinated with Cervarix (GSK’s HPV 16/18 AS04 candidate vaccine). Presented at the Annual Meeting on Women’s Cancer of the Society for Gynecologic Oncology, Tampa, Florida, USA, 9–12 March, 2008. Abstract in Gynecologic Oncology, 2008, 109:158. 17 Garland SM et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. New England Journal of Medicine, 2007, 356:1928–1943. 18 FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. New England Journal of Medicine, 2007, 356:1915–1927. 19
Palefsky J, Giuliano A, on behalf of the male quadrivalent HPV vaccine efficacy trial study group. Efficacy of the quadrivalent HPV vaccine against HPV 6/11/16/18-related genital infection in young men. Abstract of presentation at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference, 13 November 2008; http://www.eurogin.com; accessed 24 March 2009. 20 Giuliano A, Palefsky J, on behalf of the male quadrivalent HPV vaccine efficacy trial study group. The efficacy of quadrivalent HPV (types 6/11/16/18) vaccine in reducing the incidence of HPV infection and HPV-related genital disease in young men. Abstract of presentation at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference, 13 November 2008, http://www.eurogin.com; accessed 24 March 2009. 21
Harper DM. Impact of vaccination with Cervarix (trade mark) on subsequent HPV-16/18 infection and cervical disease in women 15– 25 years of age. Gynecologic Oncology, 2008, 110(Suppl 1):S11–S17. 22 See No. 28/29, 2007, pp. 252–259. 23 See No. 5, 2009, pp. 37–40. 24
Kim JJ et al. Modelling cervical cancer prevention in developed countries. Vaccine, 2008, 26(Suppl 10):K76–K86.
25
Kim JJ Andres-Beck B, Goldie SJ. The value of including boys in an HPV vaccination programme: a cost-effectiveness analysis in a low-resource setting. British Journal of Cancer, 2007, 97:1322–1328. 26 Insinga RP et al. Cost-effectiveness of quadrivalent human papillomavirus (HPV) vaccination in Mexico: a transmission dynamic model-based evaluation. Vaccine, 2007, 26:128–139. 27 Barnabas RV et al. Epidemiology of HPV 16 and cervical cancer in Finland and the potential impact of vaccination: mathematical modelling analyses. PLoS Medicine, 2006, 3:e138. 28
Techakehakij W, Feldman RD. Cost-effectiveness of HPV vaccination compared with Pap smear screening on a national scale: a literature review. Vaccine, 2008, 26:6258–6265. 29 Goldie SJ et al. Benefits, cost requirements and cost-effectiveness of the HPV16, 18 vaccine for cervical cancer prevention in developing countries: policy implications. Reproductive Health Matters, 2008, 16:86–96. 30 Conclusion: Moderate quality of scientific evidence to support HPV vaccination of young adolescent girls to prevent cervical cancer later in life (http://www.who.int/immunization/HPV_Grad_Adol_girls.pdf; accessed April 2009). 31 Conclusion: Moderate quality of scientific evidence to support administration of quadrivalent HPV vaccine to young adolescent girls to prevent anogenital warts later in life (http://www.who.int/immunization/HPV_Grad_Warts.pdf; accessed April 2009). 32
Conclusion: Very low quality of scientific evidence to support vaccination of young males to reduce risk of female cervical cancer (http://www.who.int/immunization/HPV_Grad_Males.pdf; accessed April 2009). 33 Conclusion: Very low quality of scientific evidence to support vaccination of HIV-infected young adolescent girls to prevent cervical cancer later in life (http://www.who.int/immunization/HPV_Grad_HIV.pdf; accessed April 2009). 34
Conclusion: Low quality of scientific evidence that a booster dose of HPV vaccine is not required to ensure long term protection against cervical cancer (http://www.who.int/immunization/HPV_Grad_Booster.pdf; accessed April 2009).