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- Title
Long-term immunogenicity, safety and effectiveness of Gardasil in the Nordic countries.
- Authors
Nygard, M.
- Abstract
Objectives To evaluate long-term effectiveness, safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine GARDASIL®, a pivotal randomized, placebo-controlled, double-blind, 4-year study (protocol 015-21) was extended up to 14 years in 4 Nordic countries. Interim analyses were performed at 8 years of total follow-up. Methods Nordic citizens are assigned a unique personal identification number (PIN) at birth, and are registered in a Civil Registration System in each country. A total of 2,750 subjects receiving qHPV and 2,097 receiving placebo at the start of the study 015-21 are included in effectiveness and safety analyses. 4,344 participants consented for long-term immunogenicity analyses. Neutralizing and total IgG antibody response to HPV 6/11/16/18 were detected by competitive Luminex immunoassay (cLIA) and VLP-specific total IgG Luminex Immunoassay (total IgG LIA), respectively. Results There were no cases of HPV 6/11/16/18-related disease observed through the current follow-up. There was no specific pattern of new medical condition in the two cohorts and no evidence of an increase above background. In addition, 94.4%, 95.5, 99.1% and 60.0% of patients remained seropositive to HPV 6/11/16/18 at year 8, respectively in the cLIA and 97.6%, 96.4%, 100% and 90.8% respectively in the IgG LIA. There was no evidence of HPV type-replacement against non-vaccine HPV types in young women. Discussion No breakthrough cases of disease related to vaccine HPV types have been observed among young women vaccinated with GARDASIL® through year 8. GARDASIL® continues to be generally safe and well tolerated. Immunogenicity to vaccine HPV types remains high 9 years following vaccination.
- Subjects
SCANDINAVIA; GARDASIL (Drug); IMMUNOGLOBULIN G; HUMAN papillomavirus vaccines; IMMUNOGLOBULINS
- Publication
Obstetrics & Gynaecology Forum, 2013, Vol 23, Issue 3, p36
- ISSN
1029-1962
- Publication type
Article