Last updated: 11/07/2018 15:02:09
A double blind, controlled, randomized, phase III study of the efficacy of an HPV16/18 VLP vaccine in the prevention of advanced cervical intraepithelial neoplasia (CIN2, CIN3, adenocarcinoma in situ [AIS] and invasive cervical cancer) associated with HPV16 or HPV18 cervical infection in healthy young adult women in Costa Rica
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A double blind, controlled, randomized, phase III study of the efficacy of an HPV16/18 VLP vaccine in the prevention of advanced cervical intraepithelial neoplasia (CIN2, CIN3, adenocarcinoma in situ [AIS] and invasive cervical cancer) associated with HPV16 or HPV18 cervical infection in healthy young adult women in Costa Rica
Trial description: A double blind, controlled, randomized, phase III study of the efficacy of an HPV16/18 VLP vaccine in the prevention of advanced cervical intraepithelial neoplasia (CIN2, CIN3, adenocarcinoma in situ [AIS] and invasive cervical cancer) associated with HPV16 or HPV18 cervical infection in healthy young adult women in Costa Rica
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Castle PE et al. (2008) A Comparison of two PCR-based human papillomavirus genotyping methods. J Clin Microbiol 46(10):3437-3445.
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):910-920.
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):706-714.
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.
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.
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.
Hildesheim A et al. (2007) Effect of human papillomavirus 16/18 L1 viruslike particle vaccine among young women with preexisting infection: a randomized trial. JAMA. 298(7):743-753.
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(19):2529.
Hildesheim A et al. (2014) Efficacy of the HPV-16/18 vaccine: final according to protocol results from the blinded phase of the randomized Costa Rica HPV-16/18 vaccine trial. Vaccine. 32(39):5087-5097.
Kemp T et al (2011) HPV 16/18 LI VP Vaccine Induces Cross-Neutralizing antibodies that may mediate cross-protection. Vaccine. 29(11):2011-2014.
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.
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.
Kreimer AR 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.
Kreimer AR et al. (2015) Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA trials. Lancet Oncol. 16(7):775-786.
Porras C et al. (2010) Determinants of seropositivity among HPV-16/18 DNA positive young women. BMC Infectious Diseases. 10:238.
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.
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):1653-1662.
Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
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.
Medical condition
Papillomavirus Vaccines
Product
SB208109, SB580299
Collaborators
Not applicable
Study date(s)
June 2004 to December 2010
Type
Not applicable
Phase
2/3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2010-17-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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Access to clinical trial data by researchers
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