Immunogenicity and safety of a 9-valent HPV vaccine

Pediatrics

Volumn 136, Issue 1, 2015, Pages e28-e39

  Van Damme, Pierre ^a   Olsson, Sven Eric ^b   Block, Stanley ^c   Castellsague, Xavier ^d   Gray, Glenda E ^e   Herrera, Teobaldo ^f   Huang, Li Min ^g   Kim, Dong Soo ^h   Pitisuttithum, Punnee ⁱ   Chen, Joshua ^j   Christiano, Susan ^j   Maansson, Roger ^j   Moeller, Erin ^j   Sun, Xiao ^j   Vuocolo, Scott ^j   Luxembourg, Alain ^j  

^a UNIVERSITY OF ANTWERP   (Belgium)

^b DANDERYD HOSPITAL   (Sweden)

^c Kentucky Pediatric Research Institute   (United States)

^d HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^e UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^f INSTITUTO DE INVESTIGACIÓN NUTRICIONAL   (Peru)

^g NATIONAL TAIWAN UNIVERSITY   (Taiwan)

^h Yonsei University College of Medicine   (South Korea)

ⁱ MAHIDOL UNIVERSITY   (Thailand)

^j MERCK RESEARCH LABORATORIES   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

WART VIRUS VACCINE;

ADOLESCENT; ADULT; ARTICLE; CHILD; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ERYTHEMA; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; IMMUNOGENICITY; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PAIN; PAPILLOMAVIRUS INFECTION; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SWELLING; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VACCINATION; ALPHAPAPILLOMAVIRUS; CLINICAL TRIAL; DOSE RESPONSE; FOLLOW UP; HEALTH; IMMUNOLOGY; PAPILLOMAVIRUS INFECTIONS; PREVALENCE; PROCEDURES; RETROSPECTIVE STUDY; VIROLOGY; YOUNG ADULT;

ADOLESCENT; ADULT; ALPHAPAPILLOMAVIRUS; CHILD; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; GLOBAL HEALTH; HUMANS; MALE; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; PREVALENCE; RETROSPECTIVE STUDIES; VACCINATION; YOUNG ADULT;

EID: 84934325070     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2014-3745     Document Type: Article

References (54)

1. Walboomers JMM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999;189(1): 12-19
2. de Sanjose S, Quint WG, Alemany L, et al; Retrospective International Survey and HPV Time Trends Study Group. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010; 11(11):1048-1056
3. Srodon M, Stoler MH, Baber GB, Kurman RJ. The distribution of low and high-risk HPV types in vulvar and vaginal intraepithelial neoplasia (VIN and VaIN). Am J Surg Pathol. 2006;30(12):1513-1518
4. de Sanjosé S, Alemany L, Ordi J, et al; HPV VVAP Study Group. Worldwide human papillomavirus genotype attribution in over 2000 cases of intraepithelial and invasive lesions of the vulva. Eur J Cancer. 2013;49(16): 3450-3461
5. Hatch KD. A3. Vaginal intraepithelial neoplasia (VAIN). Int J Gynaecol Obstet. 2006;94(suppl 1):S40-S43
6. Palefsky JM. Anal squamous intraepithelial lesions: relation to HIV and human papillomavirus infection. J Acquir Immune Defic Syndr. 1999;21 (suppl 1):S42-S48
7. Picconi MA, Eiján AM, Distéfano AL, et al. Human papillomavirus (HPV) DNA in penile carcinomas in Argentina: analysis of primary tumors and lymph nodes. J Med Virol. 2000;61(1):65-69
8. Stamataki S, Nikolopoulos TP, Korres S, Felekis D, Tzangaroulakis A, Ferekidis E. Juvenile recurrent respiratory papillomatosis: still a mystery disease with difficult management. Head Neck. 2007;29(2):155-162
9. Kjaer SK, Tran TN, Sparen P, et al. The burden of genital warts: a study of nearly 70, 000 women from the general female population in the 4 Nordic countries. J Infect Dis. 2007;196(10): 1447-1454
10. Garland SM, Steben M, Sings HL, et al. Natural history of genital warts: analysis of the placebo arm of 2 randomized phase III trials of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine. J Infect Dis. 2009;199(6):805-814
11. Parkin DM, Bray F. Chapter 2: the burden of HPV-related cancers. Vaccine. 2006;24 (suppl 3):S3-, 11-25
12. Christensen ND. Emerging human papillomavirus vaccines. Expert Opin Emerg Drugs. 2005;10(1):5-19
13. Garland SM, Hernandez-Avila M, Wheeler CM, et al; Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I Investigators. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007;356(19):1928-1943
14. FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007;356(19):1915-1927
15. Joura EA, Leodolter S, Hernandez-Avila M, et al. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007;369(9574):1693-1702
16. Palefsky JM, Giuliano AR, Goldstone S, et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011;365(17): 1576-1585
17. Paavonen J, Jenkins D, Bosch FX, et al; HPV PATRICIA Study Group. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle 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(9580):2161-2170
18. Brotherton JM, Fridman M, May CL, Chappell G, Saville AM, Gertig DM. Early effect of the HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study. Lancet. 2011;377(9783):2085-2092
19. Powell SE, Hariri S, Steinau M, et al. Impact of human papillomavirus (HPV) vaccination on HPV 16/18-related prevalence in precancerous cervical lesions. Vaccine. 2012;31(1):109-113
20. Baldur-Felskov B, Dehlendorff C, Munk C, Kjaer SK. Early impact of human papillomavirus vaccination on cervical neoplasia-nationwide follow-up of young Danish women. J Natl Cancer Inst. 2014; 106(3):djt460
21. Crowe E, Pandeya N, Brotherton JM, et al. Effectiveness of quadrivalent human papillomavirus vaccine for the prevention of cervical abnormalities: case-control study nested within a population based screening programme in Australia. BMJ. 2014;348: g1458
22. Tabrizi SN, Brotherton JM, Kaldor JM, et al. Fall in human papillomavirus prevalence following a national vaccination program. J Infect Dis. 2012; 206(11):1645-1651
23. Mesher D, Soldan K, Howell-Jones R, et al. Reduction in HPV 16/18 prevalence in sexually active young women following the introduction of HPV immunisation in England. Vaccine. 2013;32(1):26-32
24. Kavanagh K, Pollock KG, Potts A, et al. Introduction and sustained high coverage of the HPV bivalent vaccine leads to a reduction in prevalence of HPV 16/18 and closely related HPV types. Br J Cancer. 2014;110(11):2804-2811
25. Kahn JA, Brown DR, Ding L, et al. Vaccine-type human papillomavirus and evidence of herd protection after vaccine introduction. Pediatrics. 2012;130(2). Available at: www.pediatrics.org/cgi/content/full/130/2/e249
26. Markowitz LE, Hariri S, Lin C, et al. Reduction in human papillomavirus (HPV) prevalence among young women following HPV vaccine introduction in the United States, National Health and Nutrition Examination Surveys, 2003-2010. J Infect Dis. 2013;208(3):385-393
27. Read TR, Hocking JS, Chen MY, Donovan B, Bradshaw CS, Fairley CK. The near disappearance of genital warts in young women 4 years after commencing a national human papillomavirus (HPV) vaccination programme. Sex Transm Infect. 2011;87(7):544-547
28. Bauer HM, Wright G, Chow J. Evidence of human papillomavirus vaccine effectiveness in reducing genital warts: an analysis of California public family planning administrative claims data, 2007-2010. Am J Public Health. 2012; 102(5):833-835
29. Leval A, Herweijer E, Arnheim-Dahlström L, et al. Incidence of genital warts in Sweden before and after quadrivalent human papillomavirus vaccine availability. J Infect Dis. 2012;206(6): 860-866
30. Baandrup L, Blomberg M, Dehlendorff C, Sand C, Andersen KK, Kjaer SK. Significant decrease in the incidence of genital warts in young Danish women after implementation of a national human papillomavirus vaccination program. Sex Transm Dis. 2013;40(2): 130-135
31. Nsouli-Maktabi H, Ludwig SL, Yerubandi UD, Gaydos JC. Incidence of genital warts among U.S. service members before and after the introduction of the quadrivalent human papillomavirus vaccine. MSMR. 2013;20(2):17-20
32. Arnheim-Dahlström L, Pasternak B, Svanström H, Sparén P, Hviid A. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ. 2013;347:f5906
33. Block SL, Brown DR, Chatterjee A, et al. Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) l1 virus-like particle vaccine. Pediatr Infect Dis J. 2010;29(2):95-101
34. Slade BA, Leidel L, Vellozzi C, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009;302(7): 750-757
35. Gee J, Naleway A, Shui I, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine. 2011;29(46):8279-8284
36. Chao C, Klein NP, Velicer CM, et al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012;271(2):193-203
37. Klein NP, Hansen J, Chao C, et al. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012; 166(12):1140-1148
38. Grimaldi-Bensouda L, Guillemot D, Godeau B; PGRx-AID Study Group. Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects. J Intern Med. 2014;275(4):398-408
39. Wellings K, Collumbien M, Slaymaker E, et al. Sexual behaviour in context: a global perspective. Lancet. 2006; 368(9548):1706-1728
40. Block SL, Nolan T, Sattler C, et al; Protocol 016 Study Group. 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(5): 2135-2145
41. Schiller JT, Castellsagué X, Garland SM. A review of clinical trials of human papillomavirus prophylactic vaccines. Vaccine. 2012;30(suppl 5):F123-F138
42. Serrano B, Alemany L, Tous S, et al. Potential impact of a nine-valent vaccine in human papillomavirus related cervical disease. Infect Agent Cancer. 2012;7(1):38
43. Alemany L, Saunier M, Alvarado-Cabrero I, et al. Human papillomavirus DNA prevalence and type distribution in anal carcinomas worldwide. Int J Cancer. 2015;136(1):98-107
44. Alemany L, Saunier M, Tinoco L, et al; HPV VVAP Study Group. Large contribution of human papillomavirus in vaginal neoplastic lesions: a worldwide study in 597 samples. Eur J Cancer. 2014;50(16): 2846-2854
45. Joura EA, Giuliano AR, Iversen OE, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015;372(8):711-723
46. Roberts C, Green T, Hess E, et al. Development of a human papillomavirus competitive luminex immunoassay for 9 HPV types. Hum Vaccin Immunother. 2014;10(8):2174-103
47. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985; 4(2):213-226
48. WHO Expert Committee on Biological Standardization. Guidelines to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines. 57th report, WHO/BS/06.2050. Geneva, Switzerland: World Health Organization; 2006
49. Van Damme P. Immunogenicity and safety of a novel 9-valent HPV vaccine in girls 9-15 years of age compared to the quadrivalent vaccine. EUROGIN 2013. Available at: www.eurogin.com/2013/images/pdf/eurogin-2013-abstracts-part-1.pdf. Accessed April 11, 2015
50. Dobson SR, McNeil S, Dionne M, et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA. 2013;309(17): 1793-1802
51. Iversen OE. Long-term extension study of Gardasil in adolescents: results through month 96. EUROGIN 2013. Available at: http://www.eurogin.com/2013/images/pdf/eurogin-2013-abstracts-part-2 pdf. Accessed April 11, 2015
52. Nygard M, Kjaer S, Dillner J, et al. Long-term effectiveness and immunogenicity of Gardasil in the Nordic countries. EUROGIN 2013. Available at: http://www. eurogin.com/2013/images/pdf/eurogin-2013-abstracts-part-2 pdf. Accessed April 11, 2015
53. Palefsky J. Long-term effectiveness, tolerability and immunogenicity of quadrivalent HPV vaccine in men. EUROGIN 2013. Available at: http://www. eurogin.com/2013/images/pdf/eurogin-2013-abstracts-part-2 pdf. Accessed April 11, 2015
54. Markowitz LE, Tsu V, Deeks SL, et al. Human papillomavirus vaccine introduction-the first five years. Vaccine. 2012;30(suppl 5):F139-F148