1. Effectiveness of the AS04-adjuvanted HPV-16/18 vaccine in reducing oropharyngeal HPV infections in young females-Results from a community-randomized trial.
- Author
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Lehtinen M, Apter D, Eriksson T, Harjula K, Hokkanen M, Lehtinen T, Natunen K, Damaso S, Soila M, Bi D, and Struyf F
- Subjects
- Adolescent, Adult, Aluminum Hydroxide administration & dosage, Female, Finland epidemiology, Humans, Lipid A administration & dosage, Lipid A analogs & derivatives, Oropharyngeal Neoplasms epidemiology, Oropharyngeal Neoplasms immunology, Oropharyngeal Neoplasms prevention & control, Oropharyngeal Neoplasms virology, Oropharynx immunology, Papillomavirus Infections immunology, Papillomavirus Infections prevention & control, Papillomavirus Vaccines immunology, Pharyngeal Diseases immunology, Pharyngeal Diseases prevention & control, Pharyngeal Diseases virology, Seroepidemiologic Studies, Young Adult, Human papillomavirus 16 immunology, Human papillomavirus 18 immunology, Oropharynx virology, Papillomavirus Infections epidemiology, Papillomavirus Vaccines administration & dosage, Pharyngeal Diseases epidemiology
- Abstract
We studied effectiveness of the AS04-adjuvanted HPV-16/18 (AS04-HPV-16/18) vaccine against human papillomavirus (HPV) oropharyngeal infections associated with the increase of head/neck cancers in western countries. All 38,631 resident adolescents from 1994 to 1995 birth cohorts of 33 Finnish communities were invited in this community-randomized trial (NCT00534638). During 2008-2009, 11,275 girls and 6,129 boys were enrolled in three arms of 11 communities each. In Arm A, 90% of vaccinated girls/boys, and in Arm B, 90% of vaccinated girls received AS04-HPV-16/18 vaccine. Other Arm A/B and all Arm C vaccinated participants received control vaccine. All Arm A participants and Arm B female participants were blinded to vaccine allocation. Oropharyngeal samples were analyzed from 4,871 18.5-year-old females who attended follow-up visit 3-6 years postvaccination. HPV DNA prevalence was determined by SPF-10 LiPA and Multiplex type-specific PCR. Total vaccine effectiveness (VE) was defined as relative reduction of oropharyngeal HPV prevalence in pooled Arms A/B HPV-vaccinated females vs. all Arm C females. VE against oropharyngeal HPV-16/18, HPV-31/45 and HPV-31/33/45 infections were 82.4% (95% confidence intervals [CI]: 47.3-94.1), 75.3% (95%CI: 12.7-93.0) and 69.9% (95% CI: 29.6-87.1), respectively. In conclusion, the AS04-HPV-16/18 vaccine showed effectiveness against vaccine and nonvaccine HPV-types oropharyngeal infections in adolescent females up to 6 years postvaccination., (© 2019 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)
- Published
- 2020
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