Search

Background: Prophylactic human papillomavirus (HPV) vaccines have to provide sustained protection. We assessed efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine up to 6.4 years.Methods: Women aged 15-25 years, with normal cervical cytology, who were HPV-16/18 seronegative and oncogenic HPV DNA-negative (14 types) at screening participated in a double-blind, randomised, placebo-controlled initial study (n=1113; 560 vaccine group vs 553 placebo group) and follow-up study (n=776; 393 vs 383). 27 sites in three countries participated in the follow-up study. Cervical samples were tested every 6 months for HPV DNA. Management of abnormal cytologies was prespecified, and HPV-16/18 antibody titres were assessed. The primary objective was to assess long-term vaccine efficacy in the prevention of incident cervical infection with HPV 16 or HPV 18, or both. We report the analyses up to 6.4 years of this follow-up study and combined with the initial study. For the primary endpoint, the efficacy analysis was done in the according-to-protocol (ATP) cohort; the analysis of cervical intraepithelial neoplasia grade 2 and above (CIN2+) was done in the total vaccinated cohort (TVC). The study is registered with ClinicalTrials.gov, number NCT00120848.Findings: For the combined analysis of the initial and follow-up studies, the ATP efficacy cohort included 465 women in the vaccine group and 454 in the placebo group; the TVC included 560 women in the vaccine group and 553 in the placebo group. Vaccine efficacy against incident infection with HPV 16/18 was 95.3% (95% CI 87.4-98.7) and against 12-month persistent infection was 100% (81.8-100). Vaccine efficacy against CIN2+ was 100% (51.3-100) for lesions associated with HPV-16/18 and 71.9% (20.6-91.9) for lesions independent of HPV DNA. Antibody concentrations by ELISA remained 12-fold or more higher than after natural infection (both antigens). Safety outcomes were similar between groups: during the follow-up study, 30 (8%) participants reported a serious adverse event in the vaccine group versus 37 (10%) in the placebo group. None was judged related or possibly related to vaccination, and no deaths occurred.Interpretation: Our findings show excellent long-term efficacy, high and sustained immunogenicity, and favourable safety of the HPV-16/18 AS04-adjuvanted vaccine up to 6.4 years.Funding: GlaxoSmithKline Biologicals (Belgium). [ABSTRACT FROM AUTHOR]

Objective: To analyze the acceptability, safety, and effectiveness of thermocoagulation for the treatment of histologically proven cervical intraepithelial neoplasia grade 2-3 (CIN2-3) lesions., Methods: In a retrospective study, data were obtained for women treated for CIN2-3 lesions by thermocoagulation at the Hospital de Clínicas de Porto Alegre, Brazil, between March 6, 2012, and October 29, 2013, and followed up after 1 year. The proportions of women with no evidence of disease, adverse effects, or complications were determined., Results: Among 52 women included, 44 (85%) had no evidence of disease 1year after thermocoagulation. The rate of no disease at follow-up was similar for women treated for CIN2 (17/20 [85%]) and CIN3 (27/32 [84%]). No serious adverse effects or complications requiring hospitalization were observed during the follow-up period., Conclusion: Thermocoagulation is useful in the management of ectocervical CIN and should be integrated into public health services for management of cervical cancer., (Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

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.