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

Volumn 118, Issue 5, 2006, Pages 2135-2145

  Block, Stan L ^a   Nolan, Terry ^b   Sattler, Carlos ^c   Barr, Eliav ^c   Giacoletti, Katherine E D ^c   Marchant, Colin D ^d   Castellsagué, Xavier ^e   Rusche, Steven A ^c   Lukac, Suzanne ^c   Bryan, Janine T ^c   Cavanaugh Jr , Paul F ^c   Reisinger, Keith S ^f  

^a Kentucky Pediatric Research Institute   (United States)

^b UNIVERSITY OF MELBOURNE   (Australia)

^c MERCK RESEARCH LABORATORIES   (United States)

^d BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e CATALAN INSTITUTE OF ONCOLOGY   (Spain)

^f Primary Physicians Research   (United States)

Author keywords

HPV; Immunogenicity; Noninferiority; Pediatric; Reactogenicity; Vaccine

Indexed keywords

NEUTRALIZING ANTIBODY; VIRUS VACCINE; HUMAN PAPILLOMAVIRUS VACCINE L1, TYPE 6,11,16,18; PAPILLOMA VIRUS VACCINE; VIRUS ANTIBODY;

ADOLESCENCE; ADOLESCENT; ARTICLE; CONTROLLED STUDY; DRUG TOLERABILITY; FEMALE; HUMAN; IMMUNOGENICITY; INJECTION SITE REACTION; MALE; PRIORITY JOURNAL; PROPHYLAXIS; SCHOOL CHILD; SEROLOGY; SEX DIFFERENCE; VACCINATION; VIRUS INFECTION; VIRUS LIKE AGENT; VIRUS STRAIN; WART VIRUS; WOMEN'S HEALTH; ADULT; AGE; BLOOD; CHILD; COMPARATIVE STUDY; IMMUNOLOGY; PAPILLOMA VIRUS;

ADOLESCENT; ADULT; AGE FACTORS; ANTIBODIES, VIRAL; CHILD; FEMALE; HUMANS; MALE; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS VACCINES; VIRAL VACCINES;

EID: 33750938518     PISSN: 00314005     EISSN: 02105721     Source Type: Journal    
DOI: 10.1542/peds.2006-0461     Document Type: Article

References (37)

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. Nobbenhuis MA, Walboomers JM, Helmerhorst TJ, et al. Relation of human papilloma virus status to cervical lesions and consequences for cervical-cancer screening: a prospective study. Lancet. 1999;354:20-25
3. Baseman JG, Koutsky LA. The epidemiology of human papillomavirus infections. J Clin Virol. 2005;32(suppl 1):S16-S24
4. Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005;55:74-108
5. Wiley DJ, Douglas J, Beutner K, et al. External genital warts: diagnosis, treatment, and prevention. Clin Infect Dis. 2002;35(suppl 2):S210-S224
6. von Krogh G. Management of anogenital warts (condylomata acuminata). Eur J Dermatol. 2001;11:598-603
7. Gabbott M, Cossart YE, Kan A, Konopka M, Chan R, Rose BR. Human papillomavirus and host variables as predictors of clinical course in patients with juvenile-onset recurrent respiratory papillomatosis. J Clin Microbiol. 1997;35:3098-3103
8. Poland GA, Jacobson RM, Koutsky LA, et al. Immunogenicity and reactogenicity of a novel vaccine for human papillomavirus 16: a 2-year randomized controlled clinical trial. Mayo Clin Proc. 2005;80:601-610
9. 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;6:271-278
10. Skjeldestad FE. Prophylactic quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 virus-like particle (VlP) vaccine (Gardasil) reduces cervical intraepithelial neoplasia (CIN) 2/3 risk [Abstract LB-8a]. In: Proceedings of the 43rd Annual Meeting of the Infectious Disease Society of America. Alexandria, VA: Infectious Disease Society of America; 2005:53
11. Mount SL, Papillo JL. A study of 10 296 pediatric and adolescent Papanicolaou smear diagnoses in Northern New England. Pediatrics. 1999;103:539-545
12. Weinstock H, Berman S, Cates W Jr. Sexually transmitted diseases among American youth: incidence and prevalence estimates, 2000. Perspect Sex Reprod Health. 2004;36:6-10
13. Insinga RP, Dasbach EJ, Myers ER. The health and economic burden of genital warts in a set of private health plans in the United States. Clin Infect Dis. 2003;36:1397-1403
14. Woodman CB, Collins S, Winter H, et al. Natural history of cervical human papillomavirus infection in young women: a longitudinal cohort study. Lancet. 2001;357:1831-1836
15. Koutsky LA, Ault KA, Wheeler CM, et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med. 2002;347:1645-1651
16. 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;22:3004-3007
17. Lowe RS, Brown DR, Bryan JT, 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. 1997;176:1141-1145
18. 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;10:108-115
19. Dias D, Van Doren J, Schlottmann S, et al. Optimization and validation of a multiplexed luminex assay to quantify antibodies to neutralizing epitopes on human papillomaviruses 6, 11, 16, and 18. Clin Diagn Lab Immunol. 2005;12:959-969
20. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4:213-226
21. Castellsague X, Bosch FX, Munoz N, et al. Male circumcision, penile human papillomavirus infection, and cervical cancer in female partners. N Engl J Med. 2002;346:1105-1112
22. Bottiger M, Forsgren M. Twenty years' experience of rubella vaccination in Sweden: 10 years of selective vaccination (of 12-year-old girls and of women postpartum) and 13 years of a general two-dose vaccination. Vaccine. 1997;15:1538-1544
23. Hughes JP, Garnett GP, Koutsky L. The theoretical population-level impact of a prophylactic human papilloma virus vaccine. Epidemiology. 2002;13:631-639
24. Marsano LS, West DJ, Chan I, et al. A two-dose hepatitis B vaccine regimen: proof of priming and memory responses in young adults. Vaccine. 1998;16:624-629
25. 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;364:1757-1765
26. Deacon JM, Evans CD, Yule R, et al. Sexual behaviour and smoking as determinants of cervical HPV infection and of CIN3 among those infected: a case-control study nested within the Manchester cohort. Br J Cancer. 2000;83:1565-1572
27. Grunbaum JA, Kann L, Kinchen S, et al. Youth risk behavior surveillance: United States, 2003. MMWR Surveill Summ. 2004;53:1-96
28. Davis K, Dickman ED, Ferris D, Dias JK. Human papillomavirus vaccine acceptability among parents of 10- to 15-year-old adolescents. J Low Genit Tract Dis. 2004;8:188-194
29. Olshen E, Woods ER, Austin SB, Luskin M, Bauchner H. Parental acceptance of the human papillomavirus vaccine. J Adolesc Health. 2005;37:248-251
30. Sanders GD, Taira AV. Cost-effectiveness of a potential vaccine for human papillomavirus. Emerg Infect Dis. 2003;9:37-48
31. Kulasingam SL, Myers ER. Potential health and economic impact of adding a human papillomavirus vaccine to screening programs. JAMA. 2003;290:781-789
32. Goldie SJ, Kohli M, Grima D, et al. Projected clinical benefits and cost-effectiveness of a human papillomavirus 16/18 vaccine. J Natl Cancer Inst. 2004;96:604-615
33. Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepat. 2004;11:97-107
34. Tung CS, Middleman AB. An evaluation of school-level factors used in a successful school-based hepatitis B immunization initiative. J Adolesc Health. 2005;37:61-68
35. Middleman AB. Race/ethnicity and gender disparities in the utilization of a school-based hepatitis B immunization initiative. J Adolesc Health. 2004;34:414-419
36. Rousseau MC, Pereira JS, Prado JC, Villa LL, Rohan TE, Franco EL. Cervical coinfection with human papillomavirus (HPV) types as a predictor of acquisition and persistence of HPV infection. J Infect Dis. 2001;184:1508-1517
37. 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