Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: A randomised double-blind placebo-controlled multicentre phase II efficacy trial

Lancet Oncology

Volumn 6, Issue 5, 2005, Pages 271-278

  Villa, Luisa L ^a   Costa, Ronaldo L R ^b   Petta, Carlos A ^c   Andrade, Rosires P ^d   Ault, Kevin A ^e   Giuliano, Anna R ^f   Wheeler, Cosette M ^g   Koutsky, Laura A ^h   Malm, Christian ⁱ   Lehtinen, Matti ⁱ   Skjeldestad, Finn Egil ^j   Olsson, Sven Eric ^k   Steinwall, Margareta ^l   Brown, Darron R ^m   Kurman, Robert J ⁿ   Ronnett, Brigitte M ⁿ   Stoler, Mark H ^o   Ferenczy, Alex ^p   Harper, Diane M ^q   Tamms, Gretchen M ^r   Yu, Jimmy ^r   Lupinacci, Lisa ^r   Railkar, Radha ^r   Taddeo, Frank J ^r   Jansen, Kathrin U ^r   Esser, Mark T ^r   Sings, Heather L ^r   Saah, Alfred J ^r   Barr, Eliav ^r   more..

^a LUDWIG INSTITUTE FOR CANCER RESEARCH   (Brazil)

^b A C CAMARGO CANCER CENTER   (Brazil)

^c UNIVERSITY OF CAMPINAS   (Brazil)

^d CERHFAC   (Brazil)

^e UNIVERSITY OF IOWA   (United States)

^f UNIVERSITY OF ARIZONA   (United States)

^g UNIVERSITY OF NEW MEXICO SCHOOL OF MEDICINE   (United States)

^h UNIVERSITY OF WASHINGTON   (United States)

ⁱ NATIONAL PUBLIC HEALTH INSTITUTE   (Finland)

^j SINTEF   (Norway)

^k DANDERYD HOSPITAL   (Sweden)

^l LUND UNIVERSITY HOSPITAL   (Sweden)

^m INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁿ JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^o UNIVERSITY OF VIRGINIA   (United States)

^p MCGILL UNIVERSITY   (Canada)

^q DARTMOUTH MEDICAL SCHOOL   (United States)

^r MERCK RESEARCH LABORATORIES   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN PAPILLOMA L1 VIRUS VACCINE; PLACEBO; UNCLASSIFIED DRUG; VIRUS ANTIBODY; VIRUS DNA; VIRUS VACCINE;

ADULT; ANTIBODY BLOOD LEVEL; ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONDYLOMA; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FEMALE; FOLLOW UP; GYNECOLOGICAL EXAMINATION; HEADACHE; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 11; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; HUMAN PAPILLOMAVIRUS TYPE 6; IMMUNE RESPONSE; IMMUNOGENICITY; INCIDENCE; INJECTION SITE REACTION; LOW DRUG DOSE; MULTICENTER STUDY; PAPANICOLAOU TEST; PERSISTENT INFECTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME; UTERINE CERVIX CANCER; UTERINE CERVIX CARCINOMA IN SITU; VIRUS DETECTION; VIRUS LOAD; VIRUS PARTICLE;

ADOLESCENT; ADULT; ANTIBODIES, VIRAL; CAPSID PROTEINS; CERVICAL INTRAEPITHELIAL NEOPLASIA; DOUBLE-BLIND METHOD; FEMALE; HUMANS; ONCOGENE PROTEINS, VIRAL; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; PLACEBOS; TUMOR VIRUS INFECTIONS; UTERINE CERVICAL NEOPLASMS; VIRAL VACCINES;

EID: 20944448032     PISSN: 14702045     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1470-2045(05)70101-7     Document Type: Article

References (29)

1. FX Bosch S de Sanjose Chapter 1: Human papillomavirus and cervical cancer-burden and assessment of causality J Natl Cancer Inst Monogr 31 2003 3-13
2. J Ferlay F Bray P Pisani GLOBOCAN 2002: Cancer incidence, mortality and prevalence worldwide. IARC CancerBase No 5. Version 2.0 2004 IARC Press Lyon
3. J Peto C Gilham O Fletcher FE Matthews The cervical cancer epidemic that screening has prevented in the UK Lancet 364 2004 249-256
4. L Sadler A Saftlas W Wang et al. Treatment for cervical intraepithelial neoplasia and risk of preterm delivery JAMA 291 2004 2100-2106
5. G Persson K Andersson I Krantz Symptomatic genital papillomavirus infection in a community: Incidence and clinical picture Acta Obstet Gynecol Scand 75 1996 287-290
6. G von Krogh Management of anogenital warts (condylomata acuminata) Eur J Dermatol 11 2001 598-604
7. RD Maw M Reitano M Roy An international survey of patients with genital warts: Perceptions regarding treatment and impact on lifestyle Int J STD AIDS 9 1998 571-578
8. E-M de Villiers C Fauquet TR Broker et al. Classification of papillomaviruses Virology 324 2004 17-27
9. J Zhou XY Sun DJ Stenzel IH Frazer Expression of vaccinia recombinant HPV 16 L1 and L2 ORF proteins in epithelial cells is sufficient for assembly of HPV virion-like particles Virology 185 1991 251-257
10. LA Koutsky KA Ault CM Wheeler et al. A controlled trial of a human papillomavirus type 16 vaccine N Engl J Med 347 2002 1645-1651
11. RT Emeny CM Wheeler KU Jansen et al. Priming of human papillomavirus type 11-specific humoral and cellular immune responses in college-aged women with a virus-like particle vaccine J Virol 76 2002 7832-7842
12. DR Brown KH Fife CM Wheeler et al. Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine Vaccine 22 2004 2936-2942
13. KH Fife CM Wheeler LA Koutsky et al Dose-ranging studies of the safety and immunogenicity of human papillomavirus type 11 and type 16 virus-like particle candidate vaccines in young healthy women Vaccine 22 2004 2943-2952
14. K Ault AR Giuliano R Edwards et al. A phase I study to evaluate a human papillomavirus (HPV) type 18 L1 VLP vaccine Vaccine 22 2004 3004-3007
15. DR Brown JT Bryan JM Schroeder et al. Neutralization of human papillomavirus type 11 (HPV-11) by serum from women vaccinated with yeast-derived HPV-11 L1 virus-like particles: Correlation with competitive radioimmunoassay titer J Infect Dis 184 2001 1183-1186
16. RS Lowe DR Brown JT Bryan et al. Human papillomavirus type 11 (HPV-11) neutralizing antibodies in the serum and genital mucosal secretions of African green monkeys immunized with HPV-11 virus-like particles expressed in yeast J Infect Dis 176 1997 1141-1145
17. D Solomon D Davey R Kurman et al. The 2001 Bethesda system: Terminology for reporting results of cervical cytology JAMA 287 2002 2114-2119
18. TC Wright Jr JT Cox LS Massad et al. 2001 consensus guidelines for the management of women with cervical cytological abnormalities JAMA 287 2002 2120-2129
19. MH Stoler M Schiffman Interobserver reproducibility of cervical cytologic and histologic interpretations: Realistic estimates from the ASCUS-LSIL triage study JAMA 285 2004 1500-1506
20. D Opalka CE Lachman SA MacMullen et al. Simultaneous quantitation of antibodies to neutralizing epitopes on virus-like particles for human papillomavirus types 6, 11, 16, and 18 by a multiplexed luminex assay Clin Diagn Lab Immunol 10 2003 108-115
21. ND Christensen CA Reed NM Cladel et al. Monoclonal antibodies to HPV-6 L1 virus-like particles identify conformational and linear neutralizing epitopes on HPV-11 in addition to type-specific epitopes on HPV-6 Virology 224 1996 477-486
22. ND Christensen J Dillner C Eklund et al. Surface conformational and linear epitopes on HPV-16 and HPV-18 L1 virus-like particles as defined by monoclonal antibodies Virology 223 1996 174-184
23. ISF Chan NR Bohidar Exact power and sample size for vaccine efficacy studies Theory Meth 27 1998 1305-1322
24. Villa L, Costa R, Petta C, et al. A dose-ranging safety and immunogenicity study of a quadrivalent HPV (types 6/11/16/18) L1 VLP vaccine in women. HPV 20th International Papillomavirus Conference, Paris, France, Oct 4-9, 2002
25. DM Harper EL Franco CM Wheeler et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection of human papillomavirus type 16 and 18 in young women: A randomised controlled trial Lancet 364 2004 1757-1765
26. RP Insinga AG Glass BB Rush The health care costs of cervical human papillomavirus-related disease Am J Obstet Gynecol 191 2004 114-120
27. JA Grunbaum L Kann S Kinchen et al. Youth risk behavior surveillance - United States, 2003 MMWR Surveill Summ 53 2004 1-96
28. K Wellings K Nanchahal W Macdowall et al. Sexual behavior in Britain: early heterosexual experience Lancet 358 2001 1843-1850
29. AM Johnson CH Mercer B Erens et al. Sexual behavior in Britain: partnerships, practices, and HIV risk behaviors Lancet 358 2001 1835-1842