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HPV-023 (NCT00518336; ClinicalTrial.gov) is a long-term follow-up of an initial double-blind, randomized (1:1), placebo-controlled study (HPV-001, NCT00689741) evaluating the efficacy against human papillomavirus (HPV)-16/18 infection and associated cyto-histopathological abnormalities, persistence of immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine. Among the women, aged 15-25 years, enrolled in HPV-001 and who participated in the follow-up study HPV-007 (NCT00120848), a subset of 437 women from five Brazilian centers participated in this 36-month long-term follow-up (HPV-023) for a total of 113 months (9.4 years). During HPV-023, anti-HPV-16/18 antibodies were measured annually by enzyme-linked immunosorbent assay (ELISA) and pseudovirion-based neutralisation assay (PBNA). Cervical samples were tested for HPV DNA every 6 months, and cyto-pathological examinations were performed annually. During HPV-023, no new HPV-16/18-associated infections and cyto-histopathological abnormalities occurred in the vaccine group. Vaccine efficacy (VE) against HPV-16/18 incident infection was 100% (95%CI: 66.1, 100). Over the 113 months (9.4 years), VE was 95.6% (86.2, 99.1; 3/50 cases in vaccine and placebo groups, respectively) against incident infection, 100% (84·1, 100; 0/21) against 6-month persistent infection (PI); 100% (61·4, 100; 0/10) against 12-month PI; 97·1% (82.5, 99.9; 1/30) against ≥ ASC-US; 95·0% (68.0, 99.9; 1/18) against ≥ LSIL; 100% (45.2, 100; 0/8) against CIN1+; and 100% (-128.1, 100; 0/3) against CIN2+ associated with HPV-16/18. All vaccinees remained seropositive to HPV-16/18, with antibody titers remaining several folds above natural infection levels, as measured by ELISA and PBNA. There were no safety concerns. To date, these data represent the longest follow-up reported for a licensed HPV vaccine.

Objectives: This article reports on a survey of medical laboratorians' knowledge of quality systems in their workplace and their perceptions about the effect of job function, education and training, professional credentials, and experience on the overall quality of testing and results., Methods: The Medical Laboratory Workforce Survey was designed and conducted in Vermont in 2005. Surveys were distributed to all laboratorians working in Clinical Laboratory Improvement Amendments-regulated laboratories throughout Vermont. Results were analyzed for statistical significance using the Fisher's exact test for overall group comparisons., Results: Laboratorians perceived that they were generally knowledgeable about the quality systems in place in their laboratories (96% considered themselves familiar with quality assurance [OA] measures in their laboratory), but meeting quality objectives and perceptions of factors that impact quality measures in the laboratory were variably influenced by the laboratorians' years of experience, professional credentials, organization type, and job title. Almost half (47%) of laboratorians said they did not have a role in deciding the QA measures, whereas 77% felt they had a significant impact on meeting the QA objectives., Conclusions: Not all laboratorians feel that they play a significant role in assuring quality or influencing quality measures used in the laboratory. All laboratorians should be encouraged to take an active approach to influence quality systems in the laboratory to ensure the highest quality health care possible.