Prevention of persistent human papillomavirus infection by an HPV16/18 vaccine: A community-based randomized clinical trial in guanacaste, Costa Rica

Cancer Discovery

Volumn 1, Issue 5, 2011, Pages 408-419

  Herrero, Rolando ^a,b   Wacholder, Sholom ^c   Rodríguez, Ana C ^a   Solomon, Diane ^c   González, Paula ^a   Kreimer, Aimee R ^c   Porras, Carolina ^a   Schussler, John ^d   Jiménez, Silvia ^a   Sherman, Mark E ^c   Quint, Wim ^e   Schiller, John T ^c   Lowy, Douglas R ^c   Schiffman, Mark ^c  

^a Proyecto Epidemiologico Guanacaste   (Costa Rica)

^b INTERNATIONAL AGENCY FOR RESEARCH ON CANCER   (France)

^c NATIONAL CANCER INSTITUTE   (United States)

^d INFORMATION MANAGEMENT SERVICES INC   (United States)

^e DDL DIAGNOSTIC LABORATORY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN G ANTIBODY; VIRUS DNA; WART VIRUS VACCINE;

ADULT; ARTICLE; BIOPSY; CONTROLLED STUDY; COSTA RICA; CROSS PROTECTION; CYTOLOGY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ENZYME IMMUNOASSAY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FOLLOW UP; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; PAPILLOMAVIRUS INFECTION; POLYMERASE CHAIN REACTION; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SEROLOGY; SEXUAL INTERCOURSE; UTERINE CERVIX CANCER;

ADOLESCENT; ADULT; COHORT STUDIES; COMMUNITY-BASED PARTICIPATORY RESEARCH; COSTA RICA; FEMALE; FOLLOW-UP STUDIES; HUMAN PAPILLOMAVIRUS 16; HUMAN PAPILLOMAVIRUS 18; HUMANS; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; YOUNG ADULT;

EID: 84866662842     PISSN: 21598274     EISSN: 21598290     Source Type: Journal    
DOI: 10.1158/2159-8290.CD-11-0131     Document Type: Article

References (32)

1. Arbyn M, Castellsague X, de Sanjose S, Bruni L, Saraiya M, Bray F, et al. Worldwide burden of cervical cancer in 2008. Ann Oncol. 2011 Apr 6. [epub ahead of print].
2. Koutsky LA, Ault KA, Wheeler CM, Brown DR, Barr E, Alvarez FB, et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med 2002;347:1645-51.
3. Munoz N, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, et al. Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women. J Natl Cancer Inst 2010;102:325-39.
4. Paavonen J, Jenkins D, Bosch FX, Naud P, Salmeron J, Wheeler CM, et al. Efficacy of a prophylactic adjuvanted bivalent L1 virus-likeparticle 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;369:2161-70.
5. Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, et al. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet 2009;374:301-14.
6. Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, et al. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years. J Infect Dis 2009;199:926-35.
7. Herrero R. Human papillomavirus (HPV) vaccines: limited cross-protection against additional HPV types. J Infect Dis 2009;199:919-22.
8. Hildesheim A, Herrero R, Wacholder S, Rodriguez AC, Solomon D, Bratti MC, et al. Effect of human papillomavirus 16/18 L1 viruslike particle vaccine among young women with preexisting infection: a randomized trial. JAMA 2007;298:743-53.
9. U.S. Food and Drug Administration. VRBPAC Background Document: Gardasil" HPV Quadrivalent Vaccine: May 18, 2006 VRBPAC Meeting. Available from: http://www.fda.gov/ohrms/dockets/ ac/06/briefing/2006-4222B3.pdf.
10. Chang Y, Brewer NT, Rinas AC, Schmitt K, Smith JS. Evaluating the impact of human papillomavirus vaccines. Vaccine 2009;27:4355-62.
11. Rodriguez AC, Schiffman M, Herrero R, Wacholder S, Hildesheim A, Castle PE, et al. Rapid clearance of human papillomavirus and implications for clinical focus on persistent infections. J Natl Cancer Inst 2008;100:513-7.
12. Castle PE, Porras C, Quint WG, Rodriguez AC, Schiffman M, Gravitt PE, et al. Comparison of two PCR-based human papillomavirus genotyping methods. J Clin Microbiol 2008;46:3437-45.
13. Carreon JD, Sherman ME, Guillen D, Solomon D, Herrero R, Jeronimo J, et al. CIN2 is a much less reproducible and less valid diagnosis than CIN3: results from a histological review of populationbased cervical samples. Int J Gynecol Pathol 2007;26:441-6.
14. Jenkins D. A review of cross-protection against oncogenic HPV by an HPV-16/18 AS04-adjuvanted cervical cancer vaccine: importance of virological and clinical endpoints and implications for mass vaccination in cervical cancer prevention. Gynecol Oncol 2008;110:S18-S25.
15. Centers for Disease Control and Prevention (CDC). National, state, and local area vaccination coverage among adolescents aged 13-17 years-United States, 2009. MMWR Morb Mortal Wkly Rep 2010;59:1018-23.
16. Herrero R, Hildesheim A, Rodriguez AC, Wacholder S, Bratti C, Solomon D, et al. Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica. Vaccine 2008;26:4795-808.
17. de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol 2010;11:1048-56.
18. Castle PE, Wheeler CM, Solomon D, Schiffman M, Peyton CL. Interlaboratory reliability of Hybrid Capture 2. Am J Clin Pathol 2004;122:238-45.
19. Castle PE, Rodriguez AC, Burk RD, Herrero R, Wacholder S, Alfaro M, et al. Short term persistence of human papillomavirus and risk of cervical precancer and cancer: population based cohort study. BMJ 2009;339:b2569.
20. U.S. Food and Drug Administration. VRBPAC Briefing Document. CERVARIX. Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant. Vaccines and Related Biological Products Advisory Committee (VRBPAC). Briefing Document. September 9, 2009. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/ VaccinesandRelatedBiologicalProductsAdvisoryCommittee.
21. Plummer M, Schiffman M, Castle PE, Maucort-Boulch D, Wheeler CM. A 2-year prospective study of human papillomavirus persistence among women with a cytological diagnosis of atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion. J Infect Dis 2007;195:1582-9.
22. Chaturvedi AK, Katki HA, Hildesheim A, Rodriguez AC, Quint W, Schiffman M, et al. Human papillomavirus infection with multiple types: pattern of coinfection and risk of cervical disease. J Infect Dis 2011;203:910-20.
23. Safaeian M, Porras C, Schiffman M, Rodriguez AC, Wacholder S, Gonzalez P, et al. Epidemiological study of anti-HPV16/18 seropositivity and subsequent risk of HPV16 and-18 infections. J Natl Cancer Inst 2010;102:1653-62.
24. Winer RL, Hughes JP, Feng Q, O'Reilly S, Kiviat NB, Koutsky LA. Comparison of incident cervical and vulvar/vaginal human papillomavirus infections in newly sexually active young women. J Infect Dis 2009;199:815-832.
25. Rodriguez AC, Burk R, Herrero R, Hildesheim A, Bratti C, Sherman ME, et al. The natural history of human papillomavirus infection and cervical intraepithelial neoplasia among young women in the Guanacaste cohort shortly after initiation of sexual life. Sex Transm Dis 2007;34:494-502
26. Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, et al. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA 2002;287:2114-9.
27. Wacholder S, Chen BE, Wilcox A, Macones G, Gonzalez P, Befano B, et al. Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials. BMJ 2010;340:c712.
28. Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, et al. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine 2008;26:6630-8.
29. Kleter B, Van Doorn LJ, ter Schegeget J, Schrauwen L, van Krimpen K, Burger M, et al. Novel short-fragment PCR assay for highly sensitive broad-spectrum detection of anogenital human papillomaviruses. Am J Pathol 1998;153:1731-9.
30. Kleter B, Van Doorn LJ, Schrauwen L, Molijn A, Sastrowijoto S, ter Schegget J, et al. Development and clinical evaluation of a highly sensitive PCR-reverse hybridization line probe assay for detection and identification of anogenital human papillomavirus. J Clin Microbiol 1999;37:2508-17.
31. Van Doorn LJ, Molijn A, Kleter B, Quint W, Colau B. Highly effective detection of human papillomavirus 16 and 18 DNA by a testing algorithm combining broad-spectrum and type-specific PCR. J Clin Microbiol 2006;44:3292-8.
32. Dessy FJ, Giannini SL, Bougelet CA, Kemp TJ, David MP, Poncelet SM, et al. Correlation between direct ELISA, single epitope-based inhibition ELISA and pseudovirion-based neutralization assay for measuring anti-HPV-16 and anti-HPV-18 antibody response after vaccination with the AS04-adjuvanted HPV-16/18 cervical cancer vaccine. Hum Vaccin 2008;4:425-34.