Sustained efficacy up to 4·5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial

Lancet

Volumn 367, Issue 9518, 2006, Pages 1247-1255

  Harper, Diane M ^a   Franco, Eduardo L ^b   Wheeler, Cosette M ^c   Moscicki, Anna Barbara ^d   Romanowski, Barbara ^e   Roteli Martins, Cecilia M ^f   Jenkins, David ^g   Schuind, Anne ^h   Costa Clemens, Sue Ann ⁱ   Dubin, Gary ^h  

^a DARTMOUTH MEDICAL SCHOOL   (United States)

^b MCGILL UNIVERSITY   (Canada)

^c UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e UNIVERSITY OF ALBERTA   (Canada)

^f Hospital Nove de Julho   (Brazil)

^g GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^h GLAXOSMITHKLINE   (United States)

ⁱ Estrada dos Bandeirantes   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; VIRUS ANTIBODY; VIRUS DNA; WART VIRUS VACCINE;

ADULT; ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ENDOCRINE DISEASE; FEMALE; FOLLOW UP; HISTOLOGY; HUMAN; HUMAN CELL; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; HUMAN PAPILLOMAVIRUS TYPE 31; HUMAN PAPILLOMAVIRUS TYPE 45; HUMAN TISSUE; IMMUNOGENICITY; IMMUNOPATHOLOGY; INFECTION PREVENTION; LONG TERM CARE; MAJOR CLINICAL STUDY; METABOLIC DISORDER; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NUTRITIONAL DEFICIENCY; OUTCOME ASSESSMENT; PERSISTENT INFECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; STATISTICAL ANALYSIS; THORAX DISEASE; UTERINE CERVIX CARCINOMA IN SITU; UTERINE CERVIX CYTOLOGY; UTERINE CERVIX DISEASE; VACCINATION; VIRUS INFECTION; WART VIRUS;

ADULT; CERVICAL INTRAEPITHELIAL NEOPLASIA; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; MULTICENTER STUDIES; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; RANDOMIZED CONTROLLED TRIALS; TIME FACTORS; UTERINE CERVICAL NEOPLASMS; VIRAL VACCINES;

EID: 33646058566     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(06)68439-0     Document Type: Article

References (24)

1. Parkin D., Bray F., Ferlay J., and Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 55 (2005) 74-108
2. Sankaranarayanan R., and Ferlay J. Worldwide burden of gynaecological cancer: the size of the problem. Best Pract Res Clin Obstet Gynaecol 20 (2006) 207-225
3. Bosch F., Lorincz A., Munoz N., Meijer C., and Shah K. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol 55 (2002) 244-265
4. Cogliano V., Baan R., Straif K., Grosse Y., Secretan B., and El Ghissassi F. Carcinogenicity of human papillomaviruses. Lancet Oncol 6 (2005) 931-932
5. Walboomers J., Jacobs M., Manos M., et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 189 (1999) 12-19
6. Munoz N., Bosch F., De Sanjose S., et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 348 (2003) 518-527
7. Clifford G., Smith J., Plummer M., Munoz N., and Franceschi S. Human papillomavirus types in invasive cervical cancer worldwide: a meta-analysis. Br J Cancer 88 (2003) 63-73
8. Koutsky L., Ault K., Wheeler C., et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med 347 (2002) 1645-1651
9. Harper D., Franco E., Wheeler C., et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 364 (2004) 1757-1765
10. Villa L., Costa R., Petta C., et al. 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 Oncol 6 (2005) 271-278
11. Goldie S., Grima D., Kohli M., Wright T., Weinstein M., and Franco E. A comprehensive natural history model of HPV infection and cervical cancer to estimate the clinical impact of a prophylactic HPV-16/18 vaccine. Int J Cancer 106 (2003) 896-904
12. Wright Jr. T., Cox J., Massad L., Twiggs L., and Wilkinson E. ASCCP-Sponsored Consensus Conference. 2001 consensus guidelines for the management of women with cervical cytological abnormalities. JAMA 287 (2002) 2120-2129
13. Tang D., Geller N., and Pocock S. On the design and analysis of randomized clinical trials with multiple endpoints. Biometrics 49 (1993) 23-30
14. Peto R., Pike M., Armitage P., et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient, I: introduction and design. Br J Cancer 34 (1976) 585-612
15. Boland G., Beran J., Lievens M., et al. Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04. Vaccine 23 (2004) 316-320
16. Garcon N. Development and evaluation of AS04, a novel and improved adjuvant system containing MPL and aluminum salt. In: Schijns V., and O'Hagan D. (Eds). Immunopotentiators in modern vaccines (2005), Academic Press, London 161-178
17. Pagliusi S., and Teresa Aguado M. Efficacy and other milestones for human papillomavirus vaccine introduction. Vaccine 23 (2004) 569-578
18. Kyrgiou M., Koliopoulos G., Martin-Hirsch P., Arbyn M., Prendiville W., and Paraskevaidis E. Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: systematic review and meta-analysis. Lancet 367 (2006) 489-498
19. Moscicki A., Shiboski S., Broering J., et al. The natural history of human papillomavirus infection as measured by repeated DNA testing in adolescent and young women. J Pediatr 132 (1998) 277-284
20. Jacques P., Moens G., Desombere I., et al. The immunogenicity and reactogenicity profile of a candidate hepatitis B vaccine in an adult vaccine non-responder population. Vaccine 20 (2002) 3644-3649
21. Wideroff L., Schiffman M., Haderer P., et al. Seroreactivity to human papillomavirus types 16, 18, 31, and 45 virus-like particles in a case-control study of cervical squamous intraepithelial lesions. J Infect Dis 180 (1999) 1424-1428
22. Combita A., Bravo M., Touze A., Orozco O., and Coursaget P. Serologic response to human oncogenic papillomavirus types 16, 18, 31, 33, 39, 58 and 59 virus-like particles in Colombian women with invasive cervical cancer. Int J Cancer 97 (2002) 796-803
23. Marais D., Rose R., Lane C., Aspinall S., Bos P., and Williamson A. Seroresponses to virus-like particles of human papillomavirus types 16, 18, 31, 33, and 45 in San people of Southern Africa. J Med Virol 60 (2000) 331-336
24. Stanley M. Immune response to human papillomavirus. Vaccine (2005). (doi:10.1016/j.vaccine.2005.09.002)