Home > Result Summaries: Compounds > Human Papillomavirus Types 16 and 18 Vaccine > Result Summary for 580299/009

Result Summary for 580299/009

Result Summary

Protocol ID:	580299/009
Clinical Study ID:	580299/009
Official Title:	Study of the efficacy of an HPV16/18 VLP vaccine in the prevention of advanced cervical intraepithelial neoplasia (CIN2, CIN3, adenocarcinoma in situ and invasive cervical cancer) associated with HPV16 or HPV18 cervical infection in healthy young adult women in Costa Rica.
Phase:	phase 3
Study Indications or Diseases:	Human Papillomavirus (HPV)
Generic Name:	Human Papillomavirus Types 16 and 18 Vaccine
Trade/Product Name:	Cervarix
Approved Drug Label:	http://www.gsk.com/products.html
Results Summary:	Click here to download result summary.
Citations:	Safaeian M et al. (2007) Comparison of the SPF10-LiPA system to the Hybrid Capture 2 Assay for detection of carcinogenic human papillomavirus genotypes among 5,683 young women in Guanacaste, Costa Rica. J Clin Microbiol. 45(5):1447-1454. Hildesheim A et al. (2009) Response to "Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines" by Verstraeten et al. Vaccine. 27:2529. Kreimer A et al. (2011) Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV 16/18 vaccine. Journal of the National Cancer Institute. 103(19): 1444-1451. Herrero R et al. (2011) Prevention of persistent human papillomavirus (HPV) infection by a HPV 16/18 vaccine: a community-based randomized clinical trial in Guanacaste, Costa Rica. Cancer Discovery. 1(5):408-419. Kreimer AR et al. (2011) Efficacy of a bivalent HPV 16/18 vaccine against anal HPV16/18 infection among young women: a nested analysis within the Costa Rica Vaccine Trial. Lancet Oncology. 12(9):862-870. Katherine A et al. (2012) Adjuvanted human papillomavirus types 16/18 vaccine (Cervarix®): a guide to its use. Adis Drug Eval Drug Prof. 28(3):1-6. Chaturvedi A et al. (2011) Human papillomavirus infection with multiple types: pattern of coinfection and risk of cervical disease. Journal of Infectious Diseases. 203(7):910-20. Kemp TJ et al. (2008) Evaluation of systemic and mucosal anti-HPV16 and anti-HPV18 antibody responses from vaccinated women. Vaccine. 26(29-30):3608-3616. Castle PE et al. (2008) A Comparison of two PCR-based human papillomavirus genotyping methods. J Clin Microbiol 46(10):3437-3445. Coseo S et al. (2011) Evaluation of the polyclonal ELISA HPV serology assay as a biomarker for human papillomavirus exposure. Sexually Transmitted Diseases. 38(10):976-982. Dessy FJ et al. (2008) Correlation between direct ELISA, single epitope-based inhibition ELISA and pseudovirion-based neutralization assay for measuring anti-HPV-16 and anti-HPV-18 antibody response after vaccination with the AS04-adjuvanted HPV-16/18 cervical cancer vaccine. Hum Vaccin. 4(6):425-434. Coseo S et al. (2010) Seroprevalence and Correlates of Human Papillomavirus 16/18 Seropositivity Among Young Women in Costa Rica. Sexually Transmitted Diseases. 37(11):706-14. Porras C et al. (2010) Determinants of seropositivity among HPV-16/18 DNA positive young women. BMC Infectious Diseases. 10:238. Herrero R et al. (2008) Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica. Vaccine. 26(37):4795-4808. Hildesheim A et al. (2007) Effect of human papillomavirus 16/18 L1 virus-like particle vaccine among young women with preexisting infection: a randomized trial. JAMA. 298(7):743-753. Safaeian M et al. (2010) Epidemiological Study of Anti-HPV16/18 Seropositivity and Subsequent Risk of HPV16 and -18 Infections. J Natl Cancer Inst. 102(21):1653-62. Wacholder S et al. (2010) Risk of miscarriage in two randomized controlled trials of a bivalent vaccine against human papillomavirus types 16 and 18. British Medical Journal. 340:c1666. Kemp T et al (2011) HPV 16/18 LI VP Vaccine Induces Cross-Neutralizing antibodies that may mediate cross-protection. Vaccine. 29(11):2011-4.