Reduced Prevalence of Oral Human Papillomavirus (HPV) 4 Years after Bivalent HPV Vaccination in a Randomized Clinical Trial in Costa Rica

• DOI: 10.1371/journal.pone.0068329
• Publication Date: 2013-07-17T21:03:43Z
• Authors: Rolando Herrero; Wim Quint; Allan Hildesheim; Paula Gonzalez; Linda Struijk; Hormuzd A. Katki; Carolina Porras; Mark Schiffman; Ana Cecilia Rodri...; Diane Solomon; Silvia Jimenez; John T. Schiller; Douglas R. Lowy; Leen-Jan van Doorn; Sholom Wacholder; Aimée R. Kreimer
• Keywords: Vaccine efficacy; Hepatitis A vaccine; HPV vaccines

Background Human papillomavirus (HPV) infection, particularly with type 16, causes a growing fraction of oropharyngeal cancers, whose incidence is increasing, mainly in developed countries. In double-blind controlled trial conducted to investigate vaccine efficacy (VE) the bivalent HPV 16/18 against cervical infections and lesions, we estimated VE prevalent oral 4 years after vaccination. Methods Findings A total 7,466 women 18–25 old were randomized (1∶1) receive HPV16/18 or hepatitis as control. At final blinded 4-year study visit, 5,840 participants provided specimens (91·9% eligible women) evaluate infections. Our primary analysis evaluated infection among all vaccinated results. Corresponding was calculated for comparison. Oral prevalence identifiable mucosal relatively low (1·7%). Approximately four vaccination, there 15 control group one group, an 93·3% (95% CI = 63% 100%). same cohort at visit 72·0% 79%) (p versus 0·04). There no statistically significant protection other infections, though power limited these analyses. Conclusions vaccination ASO4-adjuvanted much lower arm compared arm, suggesting that affords strong potentially important implications prevention increasingly common HPV-associated cancer. ClinicalTrials.gov, Registry number NCT00128661