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•A community-based trial of the HPV-16/18 vaccine was conducted among 7466 women.•Vaccine efficacy was 89.8% for HPV-16/18 CIN2+ and 61.4% for any CIN2+.•The vaccine had an acceptable safety profile and induced robust antibody responses.•Results confirm the safety, immunogenicity and efficacy of the HPV-16/18 vaccine. A community-based randomized trial was conducted in Costa Rica to evaluate the HPV-16/18 AS04-adjuvanted vaccine (NCT00128661). The primary objective was to evaluate efficacy of the vaccine to prevent cervical intraepithelial neoplasia 2 or more severe disease (CIN2+) associated with incident HPV-16/18 cervical infections. Secondary objectives were to evaluate efficacy against CIN2+ associated with incident cervical infection by any oncogenic HPVs and to evaluate duration of protection against incident cervical infection with HPV-16/18. Vaccine safety and immunogenicity over the 4-year follow-up were also evaluated. We randomized (3727 HPV arm; 3739 control arm), vaccinated (HPV-16/18 or Hepatitis A) and followed (median 53.8 months) 7466 healthy women aged 18–25 years. 5312 women (2635 HPV arm; 2677 control arm) were included in the according to protocol analysis for efficacy. The full cohort was evaluated for safety. Immunogenicity was considered on a subset of 354 (HPV-16) and 379 (HPV-18) women. HPV type was assessed by PCR on cervical specimens. Immunogenicity was assessed using ELISA and inhibition enzyme immunoassays. Disease outcomes were histologically confirmed. Vaccine efficacy and 95% confidence intervals (95%CI) were computed. Vaccine efficacy was 89.8% (95% CI: 39.5–99.5; N=11 events total) against HPV-16/18 associated CIN2+, 59.9% (95% CI: 20.7–80.8; N=39 events total) against CIN2+ associated with non-HPV-16/18 oncogenic HPVs and 61.4% (95% CI: 29.5–79.8; N=51 events total) against CIN2+ irrespective of HPV type. The vaccine had an acceptable safety profile and induced robust and long-lasting antibody responses. Our findings confirm the high efficacy and immunogenicity of the HPV-16/18 vaccine against incident HPV infections and cervical disease associated with HPV-16/18 and other oncogenic HPV types. These results will serve as a benchmark to which we can compare future findings from the ongoing extended follow-up of participants in the Costa Rica trial. : Registered with clinicaltrials.gov: NCT00128661.

Influenza vaccination is recommended annually for all persons 6 months and older. Reports of increased influenza-related morbidity and mortality during the 2013–2014 influenza season raised concerns about low adult influenza immunization rates in Puerto Rico. In order to inform public health actions to increase vaccination rates, we surveyed adults in Puerto Rico regarding influenza vaccination-related attitudes and barriers. A random-digit-dialing telephone survey (50% landline: 50% cellphone) regarding influenza vaccination, attitudes, practices and barriers was conducted November 19–25, 2013 among adults in Puerto Rico. Survey results were weighted to reflect sampling design and adjustments for non-response. Among 439 surveyed, 229 completed the survey with a 52% response rate. Respondents’ median age was 55 years; 18% reported receiving 2013–2014 influenza vaccination. Among 180 unvaccinated respondents, 38% reported barriers associated with limited access to vaccination, 24% reported they did not want or need influenza vaccination, and 20% reported safety concerns. Vaccinated respondents were more likely to know if they were recommended for influenza vaccination, to report greater perceived risk of influenza illness, and to report being less concerned about influenza vaccine safety (p-value<0.05). Of the 175 respondents who saw a healthcare provider (HCP) since July 1, 2013, 38% reported their HCP recommended influenza vaccination and 17% were offered vaccination. Vaccination rates were higher among adults who received a recommendation and/or offer of influenza vaccination (43% vs. 14%; p-value<0.01). Failure of HCP to recommend and/or offer influenza vaccination and patient attitudes (low perceived risk of influenza virus infection) may have contributed to low vaccination rates during the 2013–2014 season. HCP and public health practitioners should strongly recommend influenza vaccination and provide vaccinations during clinical encounters or refer patients for vaccination.