Safety and tolerability of bivalent HPV vaccine: An Italian post-licensure study

Human Vaccines

Volumn 7, Issue SUPPL., 2011, Pages 136-146

  Gasparini, Roberto ^a   Bonanni, Paolo ^b   Levi, Miriam ^b   Bechini, Angela ^b   Boccalini, Sara ^b   Tiscione, Emilia ^b   Amicizia, Daniela ^a   Lai, Piero Luigi ^a   Sulaj, Klodiana ^a   Patria, Antonio Giuseppe ^a   Panatto, Donatella ^a  

^a UNIVERSITY OF GENOA   (Italy)

^b UNIVERSITY OF FLORENCE   (Italy)

Author keywords

HPV 16 18 AS04 adjuvated vaccine; Human papillomavirus (HPV); Vaccination; Vaccine safety; Vaccine tolerability

Indexed keywords

WART VIRUS VACCINE;

ADULT; ARTHRALGIA; CHILD; DISEASE SEVERITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; FATIGUE; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; INJECTION PAIN; INJECTION SITE SWELLING; ITALY; MAJOR CLINICAL STUDY; MYALGIA; PRURITUS; QUESTIONNAIRE; RASH; REVIEW; SCHOOL CHILD; SKIN REDNESS; SYNCOPE; URTICARIA;

ADOLESCENT; ADULT; CHILD; DRUG TOXICITY; FEMALE; HUMANS; INCIDENCE; ITALY; PAPILLOMAVIRUS VACCINES; PRODUCT SURVEILLANCE, POSTMARKETING; QUESTIONNAIRES; YOUNG ADULT;

EID: 84855732950     PISSN: 15548600     EISSN: 15548619     Source Type: Journal    
DOI: 10.4161/hv.7.0.14576     Document Type: Review

References (31)

1. Trottier H, Franco EL. The epidemiology of genital human papillomavirus infection. Vaccine 2006; 24:4-15.
2. Bosch FX, Lorincz A, Muñoz N, Meijer CJLM, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol 2002; 55:244-65.
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; 30:1513-8.
4. Forastiere A, Koch W, Trotti A, Sidransky D. Head and neck cancer. N Engl J Med 2001; 345:1890-900.
5. Herrero R, Castellsague X, Pawlita M, Lissowska J, Kee F, Balaram P, et al. Human papillomavirus and oral cancer: the International Agency for Research on Cancer multicenter study. J Natl Cancer Inst 2003; 95:1772-83.
6. Cupp MR, Malek RS, Goellner JR, Espy MJ, Smith TF. Detection of human papillomavirus DNA in primary squamous cell carcinoma of the male urethra. Urology 1996; 48:551-5.
7. Harper DM, Franco EL, Wheeler C, Ferris DG, Jenkins D, Schuind A, et al. GlaxoSmithKline HPV Vaccine Study Group. 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.
8. Harper DM, Franco EL, Wheeler CM, Moscicki AB, Romanowski B, Roteli-Martins CM, et al. HPV Vaccine Study group. 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 2006; 367:1247-55.
9. GlaxoSmithKline Vaccine HPV-007 Study Group, Romanowski B, de Borba PC, Naud PS, Roteli-Martins CM, De Carvalho NS, Teixeira JC, et al. Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet 2009; 374:1975-85.
10. Paavonen J, Jenkins D, Bosch FX, Naud P, Salmeròn J, Wheeler CM, 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; 369:2161-70.
11. Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, et al. HPV PATRICIA Study Group, Greenacre M. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet 2009; 374:301-14.
12. Jenkins D. A review of cross-protection against oncogenic HPV by an HPV-16/18 AS04-adjuvanted cervical cancer vaccine: importance of virological and clinical endpoints and implications for mass vaccination in cervical cancer prevention. Gynecologic Oncology 2008; 110:18-25.
13. Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, et al. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin 2009; 5:332-40.
14. www.Agenziafarmaco.it. Accessed August 2010.
15. Zanoni G, Berra P, Lucchi I, Ferro A, O'Flanagan D, Levy-Bruhl D, et al. Vaccine adverse event monitoring systems across the European Union countries: time for unifying efforts. Vaccine 2009; 27:3376-84.
16. www.regione.veneto.it. Accessed September 2010.
17. Ministero della Salute, Consiglio Superiore della Sanità. Sessione XLVI, sessioni congiunte II e III. Seduta dell'11 gennaio 2007.
18. DGR. Liguria n° 54 del 25 gennaio 2008.
19. DGR Toscana n° 1020 del 27/12/2007.
20. DGR Toscana n° 856 del 27 Ottobre 2008.
21. Schwarz TF, Spaczynski M, Schneider A, Wysocki J, Galaj A, Perona P, et al. Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15-55 years. Vaccine 2009; 27:581-7.
22. Einstein MH, Baron M, Levin MJ, Chatterjee A, Edwards RP, Zepp F, et al. Dubin on behalf of the HPV-010 Study Group. Comparison of the immunogenicity and safety of Cervarix and Gardasil human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years. Human Vaccines 2009; 5:705-19.
23. Brotherton JM, Kaldor JM, Garland SM. Monitoring the control of human papillomavirus (HPV) infection and related diseases in Australia: towards a national HPV surveillance strategy. Sex Health 2010; 7:310-9.
24. Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009; 302:750-7.
25. th Ed. Elk Grove Village, IL: American Academy of Pediatrics 2009.
26. Agorastos T, Chatzigeorgiou K, Brotherton JM, Garland SM. Safety of human papillomavirus (HPV) vaccines: a review of the international experience so far. Vaccine 2009; 27:7270-81.
27. Didierlaurent AM, Morel S, Lockman L, Giannini SL, Bisteau M, Carlsen H, et al. AS04, an aluminum salt- and TLR4 agonist-based adjuvant system, induces a transient localized innate immune response leading to enhanced adaptive immunity. J Immunol 2009; 183:6186-97.
28. Giannini SL, Hanon E, Moris P, Van Mechelen M, Morel S, Dessy F, et al. Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminium salt combination (AS04) compared to aluminium salt only. Vaccine 2006; 24:5937-49.
29. A Phase I/II Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus (HPV) Types 16 and 18, in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive. Available at: http://ctr.gsk.co.uk/Summary/Vaccine-Papillomavirusus/II-580299- 005-pdf; Accessed September 2010.
30. A Phase I/II Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus (HPV) Types 16 and 18, when formulated with aluminum hydroxide SBAS4 or without adjuvant in healthy adult female volunteers. Available at: http://ctr.gsk.co.uk/Summary/Vaccine- Papillomavirusus/II-580299-004-004-pdf; Accessed September 2010.
31. Garçon N, Van Mechelen M, Wettendorff M. Development and evaluation of AS04, a novel and improved immunological adjuvant system containing MPL and aluminum salt. In: immunopotentiators in Modern Vaccines. Schijns V, O'Hagan D, (Eds). Elsevier Academic Press London UK 2006; 161-77.