Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: A randomized, placebo-controlled trial in 176 Korean subjects

International Journal of Gynecological Cancer

Volumn 18, Issue 5, 2008, Pages 1013-1019

  Kang, S ^a   Kim, K H ^b   Kim, Y T ^c,d   Kim, J H ^e   Song, Y S ^f   Shin, S H ^g   Ryu, H S ^h   Han, J W ⁱ   Kang, J H ^j   Park, S Y ^a  

^a National Cancer Center   (South Korea)

^b Mokdong Hospital   (South Korea)

^c Asan Medical Center   (South Korea)

^d Yonsei University College of Medicine   (South Korea)

^e The Catholic University of Korea   (South Korea)

^f Seoul National University Hospital   (South Korea)

^g Kangnam Sacred Heart Hospital   (South Korea)

^h Ajou University Medical Center   (South Korea)

ⁱ The Catholic University of Korea   (South Korea)

^j Our Lady of Mercy Hospital   (South Korea)

more..

Author keywords

Cervical cancer; Human papillomavirus; Prevention; Randomized trial; Vaccine

Indexed keywords

PLACEBO; VIRUS VACCINE;

ADOLESCENT; ADULT; ARTICLE; BLOOD SAMPLING; CLINICAL TRIAL; COLD; CONDYLOMA ACUMINATUM; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEMOGRAPHY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 11; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; HUMAN PAPILLOMAVIRUS TYPE 6; IMMUNOGENICITY; INJECTION SITE REACTION; KOREA; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SEROCONVERSION; SIDE EFFECT;

ADOLESCENT; ALPHAPAPILLOMAVIRUS; ANTIBODIES, VIRAL; CHILD; FEMALE; HUMANS; KOREA; PAPILLOMAVIRUS VACCINES; YOUNG ADULT;

EID: 51749098990     PISSN: 1048891X     EISSN: 15251438     Source Type: Journal    
DOI: 10.1111/j.1525-1438.2007.01123.x     Document Type: Article

References (30)

1. Bosch FX, de Sanjose S. Chapter 1: human papillomavirus and cervical cancer - burden and assessment of causality. J Natl Cancer Inst Monogr 2003 31 : 3 13.
2. Shin HR, Lee DH, Herrero R et al. Prevalence of human papillomavirus infection in women in Busan, South Korea. Int J Cancer 2003 103 : 413 21.
3. Franceschi S, Herrero R, Clifford GM et al. Variations in the age-specific curves of human papillomavirus prevalence in women worldwide. Int J Cancer 2006 119 : 2677 84.
4. Shin HR, Franceschi S, Vaccarella S et al. Prevalence and determinants of genital infection with papillomavirus, in female and male university students in Busan, South Korea. J Infect Dis 2004 190 : 468 76.
5. Ho GY, Burk RD, Klein S et al. Persistent genital human papillomavirus infection as a risk factor for persistent cervical dysplasia. J Natl Cancer Inst 1995 87 : 1365 71.
6. Nobbenhuis MA, Walboomers JM, Helmerhorst TJ et al. Relation of human papillomavirus status to cervical lesions and consequences for cervical-cancer screening: a prospective study. Lancet 1999 354 : 20 5.
7. Wallin KL, Wiklund F, Angstrom T et al. Type-specific persistence of human papillomavirus DNA before the development of invasive cervical cancer. N Engl J Med 1999 341 : 1633 8.
8. zur Hausen H. Immortalization of human cells and their malignant conversion by high risk human papillomavirus genotypes. Semin Cancer Biol 1999 9 : 405 11.
9. Mach H, Volkin DB, Troutman RD et al. Disassembly and reassembly of yeast-derived recombinant human papillomavirus virus-like particles (HPV VLPs). J Pharm Sci 2006 95 : 2195 206.
10. Ault KA, Giuliano AR, Edwards RP et al. A phase I study to evaluate a human papillomavirus (HPV) type 18 L1 VLP vaccine. Vaccine 2004 22 : 3004 7.
11. Fife KH, Wheeler CM, Koutsky LA 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 2004 22 : 2943 52.
12. Harper DM, Franco EL, 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 2004 364 : 1757 65.
13. Villa LL, Ault KA, Giuliano AR et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18. Vaccine 2006 24 : 5571 83.
14. Block SL, Nolan T, Sattler C et al. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics 2006 118 : 2135 45.
15. Koutsky LA, Ault KA, Wheeler CM et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med 2002 347 : 1645 51.
16. Mao C, Koutsky LA, Ault KA et al. Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial. Obstet Gynecol 2006 107 : 18 27.
17. Villa LL, Costa RL, Petta CA 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 2005 6 : 271 8.
18. Villa LL, Costa RL, Petta CA 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. Br J Cancer 2006 95 : 1459 66.
19. Clifford GM, Gallus S, Herrero R et al. Worldwide distribution of human papillomavirus types in cytologically normal women in the International Agency for Research on Cancer HPV prevalence surveys: a pooled analysis. Lancet 2005 366 : 991 8.
20. Opalka D, Lachman CE, MacMullen SA 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 2003 10 : 108 15.
21. Christensen ND, Dillner J, Eklund C et al. Surface conformational and linear epitopes on HPV-16 and HPV-18 L1 virus-like particles as defined by monoclonal antibodies. Virology 1996 223 : 174 84.
22. Christensen ND, Reed CA, Cladel NM 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 1996 224 : 477 86.
23. Montefiori DC, Metch B, McElrath MJ et al. Demographic factors that influence the neutralizing antibody response in recipients of recombinant HIV-1 gp120 vaccines. J Infect Dis 2004 190 : 1962 9.
24. Plummer M, Franceschi S. Strategies for HPV prevention. Virus Res 2002 89 : 285 93.
25. Fisman DN, Agrawal D, Leder K. The effect of age on immunologic response to recombinant hepatitis B vaccine: a meta-analysis. Clin Infect Dis 2002 35 : 1368 75.
26. Reuman PD, Kubilis P, Hurni W et al. The effect of age and weight on the response to formalin inactivated, alum-adjuvanted hepatitis A vaccine in healthy adults. Vaccine 1997 15 : 1157 61.
27. Garland SM, Hernandez-Avila M, Wheeler CM et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. New Engl J Med 2007 356 : 1928 43.
28. FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. New Engl J Med 2007 356 : 1915 27.
29. Paavonen J, The FUTURE II Study Group. The impact of baseline subject characteristics on the efficacy, safety, and immunogenicity of a quadrivalent (types 6, 11, 16, 8) human papillomavirus (HPV) L1 virus-like particle vaccine. Presented at the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 27, 2006; San Francisco, CA.
30. Giuliano AR., The FUTURE II Study Group. An analysis of the efficacy, safety, and immunogenicity of a quadrivalent (types 6, 11, 16, 18) human papillomavirus L1 virus-like particle vaccine in peoples of differing ethnicity. Presented at the 44th Infectious Disease Society of America Annual Meeting; October 12, 2006; Toronto, ON, Canada.